Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- D-8800210900006UK
- Basic UDI-DI Code
- B-8800210900006UK
- Reference
- CGSB02
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Self Testing
- Status
- On The Market
- Manufacturer
- CareforU.Co.Ltd
Additional Description
Care Blood Glucose Test Strips work with the Care Blood Glucose Meters to quantitatively measure glucose in whole blood . The Care Blood Glucose Monitoring Systems is for self-testing outside the body (in vitro diagnostic use). The Care Blood Glucose Monitoring Systems should not be used for the diagnosis of diabetes or for testing newborns . Glucose in blood samples reacts with the chemical in the test strip to produce a small electrical current. The CareBuddy Brand of Blood Glucose Meters detect the electrical current which reflects the amount of glucose in the blood sample
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0101060101 | GLUCOSE TEST STRIPS |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex III Section 6 | 1434-IVDD-178/2022 | POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. | Expired |
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