Basic Information
- Primary DI
- D-8800210900013UG
- Basic UDI-DI Code
- B-8800210900013UG
- Reference
- CGMB02
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Self Testing
- Status
- On The Market
- Manufacturer
- CareforU.Co.Ltd
Additional Description
The CareBuddy meter is designed to be used with the CareBuddy test strip to quantitatively measure glucose in fresh venous and capillary whole blood as an aid in monitoring the effectiveness of glucose control. Capillary whole blood for testing of blood glucose can be obtained from fingertip. The CareBuddy meter with the CareBuddy test strips provide a complete test system that is meant for in vitro diagnostic use by people with diabetes at home. The system is not for use in diagnosis or screening of diabetes mellitus. Healthcare professional blood sample collection and preparation is described in the test strip package insert. For use only with the CareBuddy test strips and control solutions. Suitable for self-testing
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0201060102 | BLOOD GLUCOSE METERS |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex III Section 6 | 1434-IVDD-178/2022 | POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. | Expired |
Similar Devices
Other on-the-market devices with the same classification (Eu Ivd Self Testing) and regulation (EU IVDD).