Item
N°

Product Name

Product Description

Unit of Measure

Quantity

1

Impedance audiometer (tympanometer)

Tympanometer is a medical device used to test how well the middle ear works and diagnose problems related to hearing loss. The test establishes the condition and movements of the eardrum (tympanic membrane) as it responds to changes in pressure.

Technical specifications:

• Instrument type: Screening tympanometer
• Available Testing:
  
  • Tympanometry
  • Acoustic reflex measurement testing.
• Patient Scope: patients from six months of age and up
• Power supply: Rechargeable battery integrated.
• User interface: at least LCD display to visualize the information and buttons to navigate.
• Tympanometry features:
  
  • Probe tone level: 226Hz ±2%, 85dB SPL.
  • Analysis performed:
    
    • Admittance / Compliance peak level (in ml),
    • Pressure of same;
    • Gradient (in daPa);
    • Ear Canal Volume (ECV) @ 200 daPa.
  • Ear volume measurement range, at least: 0.2ml to 5m
  • Pressure levels: at least from -400 daPa to +200daPa.
  • Pressure limits: max. from -800 to +600daPa

• Acoustic reflex measurement testing features:
  
  • Reflex type: at least Ipsilateral
  • Reflex settings:
    
    • Reflex levels, at least four (4) of the follows: 100dB with 10dB steps; 100dB, 95dB, 90dB, 85dB with 5dB steps.
    • Reflex Frequency: at least 500, 1k, 2k, and 4kHz (individually selectable)
    • Reflex threshold: at least 0.01ml to 0.5ml configurable in 0.01ml increments.
    • Reflex analysis, at least: Reflex pass/fail at each level tested; Maximum amplitude of each reflex.

• Internal memory at least for 18 patients
• Visualization menu once testing was performed, at least:
  
  • Save the results in the internal database,
  • Review the test results,
  • Print the results,
  • Delete result,
• Data management, at least:
  
  • patient initials,
  • time and date of recording,
  • tympanogram and reflex graphs,
  • whether the test is for the Left (L), Right (R) or both (2) ears.
• Interface to PC by USB port to visualize the test result, save in data base and print the reports. The Software to visualization, report and print must be included.
• Interface to printer by USB or serial port or Bluetooth.

Electrical Requirements:

• Voltage: 230 V, 50 Hz
• Plug type: C or F
• All electrical connection according with the destination Country standards (Ukraine)

Accessories:

• Transport case.
• Battery charger with power supply cable.

• USB Cable to interface to PC
• Disposable Ear Tip Starter Set (25 of each type)
• Probe Tip Cleaning Kit
• Calibration test cavity
• Printer thermal kit (thermal printer, printer cable, battery charger, power supply cable, printer paper roll)
• Manuals and Software

Documentation requirement:

• Instructions for use to be provided (including operation instructions, maintenance and procedures for decontamination, storage conditions, safe disposal).
• Indications in the language of the destination country (Ukraine) or at least in English as mandatory.
• Contact details of manufacturer, supplier and local service agent must be provided.
• Certificate of calibration and inspection to be provided.
• List of equipment and procedures required for local calibration and routine maintenance must be provided.
• List of common spares and accessories with part numbers must be provided.
• Manufacturer authorization.
• Free sale certificate of origin country if other than Ukraine.

Other requirements:

1. All standard accessories, consumables and parts required to operate the equipment, including all standard tools, cleaning and lubrication materials must be included.
2. Must be included at least two (2) years of full onsite warranty including 2 yearly preventive maintenances, full corrective maintenance, including works and spare parts.
3. Must be included training on use, cleaning, disinfecting and basic maintenance on-site or in teleconference for at least 4 hours.

Regulatory approvals required: 

• National Regulatory Agency/Authority (NRA) requirements compliance.
• And at least one of the follows:

• European Certificate of Conformity (CE) with directive 93/42 EC or regulation 2017/745 (with indication of Notifying Body).
• FDA (Food and Drug Administration) of the USA that certifies marketing permission in the United States.
• Other regulatory body of an IMDRF founding member country such as Australia, Canada, or Japan.

For general manufacturing:

• ISO 13485: Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes
• ISO 14971: Medical Devices - Application of Risk Management to Medical Devices
• ISO 15223-1: Medical devices -- Symbols to be used with medical device labels, labelling and information to be supplied -- Part 1: General requirements.

Safety & product Standards:

Bidder shall furnish the documentary evidence to demonstrate that the good it offers meet the international safety & regulatory standards providing a signed and dated Declaration of Conformity (DoC) according to ISO 17050 stating compliance to the follow standards:

• IEC 60601-1 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
• IEC 60601-1-2 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
• ANSI S3.39 Specification for Instruments to measure Aural Acoustic Impedance and Admittance (Aural Acoustic Immittance) / IEC 60645-5 Electroacoustics - Audiometric Equipment – Instruments for the measurement of aural acoustic impedance/admittance.

Piece

1

2

Otoscope

Otoscope set for visual examination of the eardrum and the outer ear, comes including two sets of four different sized reusable specula, a bulb and tube, a storage case, and required batteries.

General Description:

An electrically powered, hand-held device designed for examination of the outer ear canal and tympanic membrane (eardrum) by direct viewing through the ear opening. It consists of a main unit (commonly referred to as the head) with a built-in light source intended to illuminate the interior of the ear canal with a detachable cone-shaped tube (speculum) inserted in the ear canal; it may facilitate the application of air pressure for pneumatic otoscopy. A dedicated power supply handpiece and/or an insufflation bulb may be included with the head.

Technical Specification:

Handle with a built-in LED light source in a mounted head. Including rotatable viewing lens with a magnification between 3 times. Colour temperature: Cool white in the range 3,200-4,000K. Including reusable, autoclavable specula. Specula are cleanable with alcohol wipes. Handle contains on/off switch. Includes a port to connect an insufflation bulb. Uses 2 x type AA Alkaline batteries as a power source. Is able to withstand frequent cleaning and disinfecting with hospital grade products.

Certificates:

Self-declared CE under the EU MDR 2017/745 as Class I device. Manufacturer is certified for ISO 13485 Medical devices

- Quality management systems. - Supplier is certified for ISO 9001 Quality management systems. - IEC 60601-1:2005 + A1:2012(E) Medical electrical equipment. - IEC 60601-1-2:2014 Medical electrical equipment. - EN ISO 15223-1 (EN 980) Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied.

- National Regulatory Agency/Authority (NRA) requirements compliance.

Piece

3

3

Head lamp

Portable medical head light composed of the illuminator, adjustable headband and battery charger.

Technical specifications:

• Lamp type: LED
• Light intensity: at least 70,000 lux
• Color temperature: cool white light (approx. between 4500 to 6000°K)
• Lamp lifespan: at least 50,000 hours
• Adjustable light beam width at least from 30mm to 70 mm
• Power supply: Rechargeable battery integrated.
• Operating time: autonomy at least 4 hours
• Battery charging time: less than 6 hours
• Weight: less than 400g.

Electrical Requirements:

• Voltage: 230 V, 50 Hz
• Plug type: C or F
• All electrical connection according with the destination Country standards (Ukraine)

Accessories:

• Transport case.
• Battery charger.

Documentation requirements:

• Instructions for use and service manuals to be provided (including operation instructions, maintenance and procedures for decontamination, storage conditions, safe disposal).
• Indications in the language of the destination country (Ukraine) or at least in English as mandatory.
• Contact details of manufacturer, supplier and local service agent must be provided.
• Certificate of calibration and inspection to be provided, if applicable.
• List of equipment and procedures required for local calibration and routine maintenance must be provided.
• List of common spares and accessories with part numbers must be provided.
• Manufacturer authorization.
• Free sale certificate of origin country if other than Ukraine

Other requirements:

1. All standard accessories, consumables and parts required to operate the equipment, including all standard tools, cleaning and lubrication materials must be included.
2. Must be included at least two (2) years of full onsite warranty including 2 yearly preventive maintenances, full corrective maintenance, including works and spare parts.
3. Must be included training on use, cleaning, disinfecting and basic maintenance on-site or in teleconference for at least 2 hours.

Regulatory approvals required: 

• National Regulatory Agency/Authority (NRA) requirements compliance.
• And at least one of the follows:

• European Certificate of Conformity (CE) with directive 93/42 EC or regulation 2017/745 (with indication of Notifying Body).
• FDA (Food and Drug Administration) of the USA that certifies marketing permission in the United States.
• Other regulatory body of an IMDRF founding member country such as Australia, Canada, or Japan.

For general manufacturing:

• ISO 13485: Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes
• ISO 14971: Medical Devices - Application of Risk Management to Medical Devices
• ISO 15223-1: Medical devices -- Symbols to be used with medical device labels, labelling and information to be supplied -- Part 1: General requirements.

Safety & product Standards:

Bidder shall furnish the documentary evidence to demonstrate that the good it offers meet the international safety & regulatory standards providing a signed and dated Declaration of Conformity (DoC) according to ISO 17050 stating compliance to the follow standards:

• IEC 60601-1 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
• IEC 60601-1-2 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
• IEC 62366 Medical devices - Application of usability engineering to medical devices

Piece

3

4

Ophthalmoscope

Ophthalmoscope set to visualize the interior of the eye, with the instrument relatively close to the subject's eye and the observer viewing an upright magnified image. Ophthalmoscope set composed of diagnostic head threaded on a handle.

General Description:

An electrically-powered, hand-held, ophthalmic instrument designed to be held close to the patient’s eye to examine the interior of the eye and related structures [e.g., fundus (retina), cornea, aqueous, lens, and vitreous] by producing an upright (unreversed) image of approximately 5 times magnification. It consists of a main unit (commonly referred to as the head) with a built-in light source directed through the pupil to illuminate the interior of the eyeball, a mirror with a single hole for viewing, and a dial containing lenses of different powers; a dedicated power supply handpiece may be included with the head.

Technical Specification:

Ophthalmoscope set composed of diagnostic head mounted on a handle. Range of lenses not smaller than -35D to +40D, adjustable in steps. Anti-reflection lens. Ability to magnify at least five times. Available apertures at a minimum: small, large and semi-circle, fixation star. Colour temperature: Cool white in the range 3,500-4,000 K. Red-free, blue, and green filters. Handle with on/off switch. Provided with an LED light source. Is able to withstand frequent cleaning and disinfecting with hospital grade products.

Certificates:

Self-declared CE under the EU MDR 2017/745 as Class I device. Manufacturer is certified for ISO 13485 Medical devices

- Quality management systems. - Supplier is certified for ISO 9001 Quality management systems. - IEC 60601-1:2005 + A1:2012(E) Medical electrical equipment. - IEC 60601-1-2:2014 Medical electrical equipment. - EN ISO 15223-1 (EN 980) Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied.

- National Regulatory Agency/Authority (NRA) requirements compliance.

Piece

3

5

Set of lenses

Set of ophthalmic trial eyeglass lenses 266 helps the ophthalmologist determine the optimal corrective lenses for each patient based on their needs and requirements.

The set shall include 266 different lenses with various diopters, curvatures, and designs, which can be inserted into frames to assess their impact on vision.

Technical specifications:

• Trial eyeglass lenses made of glass with metal frame of 38 mm outer diameter.
• The set of 266 trial glass eyeglass lenses consist of:
  
  • Spherical lenses: range at least from ± 0.25 to ± 20 diopters
  • Cylindrical lenses: range at least from ± 0.25 to ± 6.00 diopters
  • Prismatic lenses: range at least from 0.50 to 10.0 diopters
  • Accessories lenses: at least red, green, black, plane, Maddox, slit, cross, frosted, pinhole, cross cylinder.

• Trial Frame:
  
  • Lightweight for use also in children.
  • Designed for fitting complex eyeglasses and various ophthalmic examinations.
  • Range of interpupillary distances: at least between 54 to 70mm.
  • At least four lens slots on each side of 38 mm diameter: three in front and one in back.
  • The lens holders can freely rotate with the inserted lenses, allowing measurements of meridional angles using circular scales on the lens holder frame.
  • The frame allows for adjustment of vertex distance and interpupillary distance.

Accessories:

• Metal portable case
• Lens cloth

Documentation requirements:

• Instructions for use to be provided (including operation instructions, procedures for decontamination, storage conditions, safe disposal).
• Indications in the language of the destination country (Ukraine) or at least in English as mandatory.
• Contact details of manufacturer, supplier and local service agent must be provided.
• Certificate of calibration and inspection to be provided, if applicable.
• List of equipment and procedures required for local calibration and routine maintenance must be provided, if applicable.
• List of common spares and accessories with part numbers must be provided.
• Manufacturer authorization.
• Free sale certificate of origin country if other than Ukraine`

Other requirements:

1. All standard accessories, consumables and parts required to operate the equipment, including all standard tools, cleaning and lubrication materials must be included.
2. Must be included at least two (2) years of full onsite warranty.
3. Must be included training on use, cleaning, disinfecting and basic maintenance on-site or in teleconference for at least 1 hours.

Regulatory approvals required: 

• National Regulatory Agency/Authority (NRA) requirements compliance.
• And at least one of the follows:

• European Certificate of Conformity (CE) with directive 93/42 EC or regulation 2017/745 (with indication of Notifying Body).
• FDA (Food and Drug Administration) of the USA that certifies marketing permission in the United States.
• Other regulatory body of an IMDRF founding member country such as Australia, Canada, or Japan.

For general manufacturing:

• ISO 13485: Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes
• ISO 14971: Medical Devices - Application of Risk Management to Medical Devices
• ISO 15223-1: Medical devices -- Symbols to be used with medical device labels, labelling and information to be supplied -- Part 1: General requirements.

Safety & product Standards:

Bidder shall furnish the documentary evidence to demonstrate that the good it offers meet the international safety & regulatory standards providing a signed and dated Declaration of Conformity (DoC) according to ISO 17050 stating compliance to the follow standards:

• ISO 9801 Ophthalmic instruments – Trial case lenses
• ISO 15004-1 Ophthalmic instruments — Fundamental requirements and test methods — Part 1: General requirements applicable to all ophthalmic instruments
• ISO 12867 Ophthalmic instruments — Trial frames

Set

1

6

Pulse Oximeter

Finger clip mounting, battery powered, all-in-one pulse oximeter displaying patient oxygen saturation (SpO2) and pulse rate. It is intended for spot-checking of adult and pediatric patients.

Technical Description:

Ultra-compact pulse oximeter integrated into finger/toe clip. Robust shock resistant design allow use in demanding environments. Suitable for professional clinical use, all patient categories neonate, infant, adult. Accommodates finger/toe thicknesses 8 to 25mm directly or through the use of a separate sensor which can be connected to the device. Spot-check of arterial blood oxygen saturation (SpO2) and heart rate (HR).

Technical Specification:

Measuring ranges: SpO2 detection within the range of: 70 to 99%; SpO2 resolution: 1% or less; SpO2 accuracy within: +/-3%; Pulse rate detection: 30 to 240 bpm; Pulse rate resolution: 1 bpm; Pulse rate accuracy: within: +/-3%; Display shows SpO2, pulse rate, signal strength, sensor error or disconnect and low battery. Enclosure protection IPX2 or better. Suitable for cleaning and disinfection with hospital-grade cleaning products. Power requirements two 1.5V AAA batteries. Batteries must allow at least 2500 spot-checks, calculated at 30 seconds per spot-check, or at least 21 hours of operation. The unit is equipped with an automatic power off feature.

Certificates:

CE certificate 93/42/EEC Risk class Iia. ISO 13485:2003 Medical devices -Quality management systems. ISO 80601-2-61 Medical electrical equipment. Charger certified to IEC 60601-1 - Medical electrical equipment

- National Regulatory Agency/Authority (NRA) requirements compliance.

Piece

3

7

Thermometer infrared

Infrared (IR), non-contact, clinical thermometer, digital, handheld, range 34 – 42 °C, including batteries.

Technical Description:

A hand-held, electrically-powered instrument designed to estimate the temperature of a site on the skin (e.g., axilla, forehead) by measurement of body infrared emissions at this particular point. It provides a method to determine temperature patterns or variations on the surface of the skin (e.g., due to differences in perfusion). This device may be used in the home. This is a reusable device.

Technical Specification:

Measurement of skin temperature trough infrared radiation detection. IR spectral response 6,000 – 14,000 nm. Preferred measuring distance 3 - 7 cm. Accuracy 0.2°C in the range of 35 - 42°C. Graduation 0.1°C. Out of range indication required. Display visualization of measured temperature, low battery, and malfunction. Display easy to read in all levels of ambient light. Digital read-out in Celsius or Fahrenheit, user selectable. Low and high temperature indication. Temperature measurement range 32 – 43 °C. Response (measurement) time within 2 s. Response (measurement) time within 2 s. Ready-to-use after switch-on within 10 s. Automatic switch-off when not in use. Automatic self-test on switch-on. Visual and/or audible alert on switch-on, ready-to-use and measurement completed. Full batteries allow for a minimum of 1,000 measurements. The unit is light weight and designed to facilitate easy operation for prolonged durations. Designed to withstand frequent cleaning and disinfection with hospital-grade products.

Certificates:

CE certified under the EU MDD 93/42/EEC as Class IIa device. Manufacturer is certified for ISO 13485 Medical devices - Quality management systems. - Supplier is certified for ISO 9001 Quality management systems. ISO 80601-2-56: 2017: Medical electrical equipment. ASTM E1112-00(2018) Standard specification for electronic thermometer for intermittent determination of patient temperature. - IEC 60601-1:2005 + A1:2012(E) Medical electrical equipment. IEC 60601-1-2:2014 Medical electrical equipment. EN ISO 15223-1 (EN 980) Medical devices

- National Regulatory Agency/Authority (NRA) requirements compliance.

Piece

3

8

Sphygmo-manometer (child & adult)

Sphygmomanometer (adult & child), aneroid sphygmomanometer. Measures blood pressure non-invasively by displaying the pressure in a cuff wrapped around a patient’s arm. The systolic and diastolic pressure is usually assessed by listening to Korotkoff sounds generated by arterial blood flow using a stethoscope simultaneously.

Technical Description:

A device designed to measure blood pressure consisting of an inflatable cuff that fits around a limb (arm or thigh), an inflation bulb for controlling the air pressure within the cuff, an aneroid manometer, and tubing. The aneroid manometer consists of a metal bellows, which expands as the pressure in the cuff increases, and a mechanical amplifier that transmits this expansion through a lever to an indicator needle, which rotates around a circular, calibrated scale. The manometer is hand held (portable); blood pressure measurement is taken in conjunction with a stethoscope.

Technical Specification:

Composed of a cuff containing an inflatable bag. The inflatable bag is connected via a tube to a bulb with an integrated manometer needle gauge. The cuff is made of durable material (e.g. nylon), which is non-deformable, and washable at 30°C. The cuff is fitted with double Velcro fastening, enabling a tight and secure fit around arms. The cuff is reinforced at both sides. Size cuff for adult & children. The bag is inflated by means of the flexible bulb connected via a tube. Material tube: rubber or other suitable material, e.g. silicone rubber, crack resistant. Length tube: 70 cm. Equipped with a universal quick connector for connection inflation bulb. Gauge graduated 0 - 300mmHg (min) in 2 (max) mmHg increments, with pressure release valve. Accuracy as per ISO 81060-1: +/- 3mm Hg. Latex and mercury free design. This model is designed to withstand shocks and vibration. Gauge body to allow recalibration of readings, yet in normal operation be sealed and secure. Calibration should only be done by the manufacturer or a authorized dealer.

Certificates:

CE certified under EU MDD 93/42 as a Class Im device, or CE certified under EU MDR 2017/745 as Class Im device. Manufacturer is certified for ISO 13485 Medical devices - Quality management systems. - Supplier is certified for ISO 9001 Quality management systems. - ISO 81060-1 Non-invasive sphygmomanometers. - ISO 10993-1, Biological Evaluation of Medical Devices. - EN ISO 15223-1 (EN 980) Medical devices

- National Regulatory Agency/Authority (NRA) requirements compliance.

Piece

3

9

Glucometer

Blood glucose meter intended for use for single-patient self-testing for the quantitative determination of blood glucose.

The device must be composed of glucose test strips and a hand meter that measures and displays the result.

Technical specifications:

• Measurement method: Enzymatic method with photometric, amperometric, electrochemical, biosensor detection, other. The method available must be specified in the offer.
• Measurement range: at least from 20 up to 500 mg/dL (1.1 to 27,8 mmol/L). 
• Measurement speed/time: less than 10 seconds
• Blood sample volume: at least 2 µl or less.
• User interface: at least LCD display,
• Displayed parameters: at least test result, alarm indicator, clock with time display for selected measurements.
• Storage of measurements: at least the last 200 measurements
• Function to calculate the average result: at least for 7, 14, or 28 days.
• Operating ambient temperature: At least in the range from 10-40°C.
• Weight of the glucometer: not greater than 80g. including batteries.
• Alarms/Messages: at least should be available test failure, low battery, test strips problems (expired or inserted wrong side) and malfunction.
• Power supply: Single use battery (lithium battery CR2032 or Alkaline AAA or AA battery or equivalent that must be specified).
• Auto power-off: at least after two minutes of inactivity

Accessories:

• Hand Case. 
• Test strips: at least 500 test strips (the strips should have at least 6 months expiry date from the date of delivery). Packaging: not more than 50 per each package or container.
• Safety lancets: at least 500 lancets single use, sterile, to be used without a lancing device, pre-loaded and unable to be reused. Without lancet removal ready to be disposed of after one-use.
• Control solutions, if needed.
• All other reagents, accessories and consumables needed to have a "ready to start" system shall be provided by bidder/manufacturer and should be available in the local market.

Documentation requirement:

• Instructions for use and service manuals to be provided (including operation instructions, maintenance and/or procedures for decontamination, storage conditions, safe disposal.
• Indications in the language of the destination country (Ukraine) or at least in English as mandatory.
• Contact details of manufacturer, supplier and local service agent must be provided.
• Certificate of calibration and inspection to be provided, if applicable.
• List of equipment and procedures required for local calibration and routine maintenance must be provided, if applicable.
• List of common spares and accessories with part numbers must be provided.
• Manufacturer authorization.
• Free sale certificate of origin country if other than Ukraine.

Other requirements:

1. All standard accessories, consumables and parts required to operate the equipment, including all standard tools, cleaning and lubrication materials must be included.
2. Must be included at least two (2) years of full onsite warranty.
3. Must be included training on use, cleaning, disinfecting and basic maintenance on-site or in teleconference for at least 1 hours, if applicable.

Regulatory approvals required: 

• National Regulatory Agency/Authority (NRA) requirements compliance.
• And at least one of the follows:

• CE mark conforming to In Vitro Diagnostic Regulation (EU) 2017/746 or Directive 98/79/EC (IVDD) (with indication of Notifying Body).
• FDA (Food and Drug Administration) of the USA that certifies marketing permission in the United States.
• Other regulatory body of an IMDRF founding member country such as Australia, Canada, or Japan.

For general manufacturing:

• ISO 13485: Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes
• ISO 14971: Medical Devices - Application of Risk Management to Medical Devices
• ISO 15223-1: Medical devices -- Symbols to be used with medical device labels, labelling and information to be supplied -- Part 1: General requirements.

Safety & product Standards:

Bidder shall furnish the documentary evidence to demonstrate that the good it offers meet the international safety & regulatory standards providing a signed and dated Declaration of Conformity (DoC) according to ISO 17050 stating compliance to the follow standards:

• ISO 15197 In vitro diagnostic test systems — Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus.
• IEC 61326 Electrical equipment for measurement, control and laboratory use - EMC requirements

Piece

3

Contact person

Iryna Bohun

Email address

ua-procurement@unfpa.org

Lot and Item No.

Quantity, pcs

Unit price, USD, CPT (Kyiv)

Total price, USD, CPT (Kyiv)

Delivery schedule (days)

1. Impedance audiometer (tympanometer)

1

2. Otoscope

3

3. Head lamp

3

4. Ophthalmoscope

3

5. Set of lenses

1

6. Pulse Oximeter

3

7. Thermometer infrared

3

8. Sphygmomanometer (child & adult)

3

9. Glucometer

3

3.1         Is the product CE marked?

Certification body and number:
Click here to enter text.

□            Yes

Start Date: Click here to enter text.
Expiry Date: Click here to enter text.

□            No

3.2         Is the product FDA approved?

            510k clearance #: Click here to enter text.
            PMA clearance #: Click here to enter text.

□            Yes

Start Date: Click here to enter text.
Expiry Date: Click here to enter text.

□            No

3.3        Is the product approved by National Regulatory Agency or Department?

Name of agency and type of approval: Click here to enter text.

□            Yes

Start Date: Click here to enter text.
Expiry Date: Click here to enter text.

□            No

3.4        Provide details of any other current regulatory approvals for this product.

Name of jurisdiction and type of approval: Click here to enter text.

□            Yes

Start Date: Click here to enter text.
Expiry Date: Click here to enter text.

□            No

Name and address of the subcontractor

QMS certification of the subcontractor - Identify Regulatory body and/or number and expiry date

Click here to enter text.

Click here to enter text.

If the device contains Lithium metal and Lithium ion batteries, does it comply with clause 38.3 of the recommendations on “Transport Of Dangerous Goods” from the United Nations?

        Yes ☐       No ☐

Does it comply with the latest IATA Dangerous Goods Regulations (DGR)?

        Yes ☐       No ☐

Testing laboratory, Test Report reference, specify standard

Click here to enter text.

Product class
(EC MEDDEV)

Minimum documentation required
Documents to be submitted must be true and valid copies. All documents submitted must be in English or be accompanied with certified translation.

class I
(non-measuring, non-sterile and/or
non-reusable surgical instrument, rsi)

☐  Copy of ISO 13485* (or ISO 9001*) QMS certificate.
☐  A signed and dated Declaration of Conformity (DoC) according to ISO 17050 stating compliance to the relevant ISO standards and directives (for manufacturer), and which has reference to the offered product.
☐  Photo of the product and packaging (at various angles if necessary, preferably in a format where the dimensions and features can be visually verified from the photos).

class I measuring
class I sterile
class I rsi
class IIa

☐  Copy of EC certificate (referencing the name/number of the notifying body), and/or 510k FDA clearance, and/or approval letter or certificate from a National Regulatory Body.
☐  A signed and dated DoC according to ISO 17050 stating compliance to critical ISO standards (e.g. for sterilization, ISO 13485 QMS) and directives, and which has reference to the offered product. Note: If a sterilization activity is subcontracted to a third party, ISO 13485 QMS compliance is also required from the subcontracting company.
☐  Photo of the product and packaging (at various angles if necessary, preferably in a format where the dimensions and features can be visually verified from the photos).

class IIb
class III  

☐  Copy of EC certificate (referencing the name/number of the notifying body) with an additional copy EC Design Examination certificate, and/or 510k/PMA FDA clearance, and/or approval letter or certificate from a National Regulatory Body.
☐  A signed and dated DoC according to ISO 17050 stating compliance to critical ISO standards (e.g. ISO 13485 QMS) and directives, and which has reference to the offered product. Proof of compliance to ISO standards in a form of copies of certificates shall be submitted if available.
☐  Photo of the product and packaging (at various angles if necessary, preferably in a format where the dimensions and features can be visually verified from the photos).