Eu Ivdd
Eu Ivd Self Testing
On The Market
🇨🇳 China
GLUCOSE TEST STRIPS
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- D-01B0112Y8
- Basic UDI-DI Code
- B-01B0112Y8
- Reference
- 4B002
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Self Testing
- Status
- On The Market
- Manufacturer
- Changsha Sinocare Inc.
Additional Description
The SPUG Blood Glucose Test Strip is to be used with the SPUG Blood Glucose and Uric Acid Meter to quantitatively measure glucose in human whole blood taken from the fingertip (capillary) or from the vein venous). It is intended for self-testing or professional use as an aid in the management of diabetes. lt is intended for use outside the body (in-vitro diagnostic use).
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0101060101 | GLUCOSE TEST STRIPS |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | No. V1 060250 0017 | TÜV SÜD Product Service GmbH | Expired |
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