Devices (same UDI-DI)
1
Certificates
1
Countries
3
Notified Bodies
1
Basic Information
- Primary DI
- 06934175004690
- Basic UDI-DI Code
- B-06934175004690
- Reference
- 5Y002DD
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Annex 2 List B
- Status
- On The Market
- Manufacturer
- Changsha Sinocare Inc.
Additional Description
The Safe AQ pro I blood glucose test strip is used only with Safe AQ pro I blood glucose meter to quantitatively measure glucose in human whole blood taken from the fingertip (capillary) or from the vein (venous). It is intended for use outside the body only (in vitro diagnostic use)for self-testing or professional use as an aid in the management of diabetes. lt should not be used for the screening or diagnosis of diabetes. The test strips require No Coding.
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 |
Available In Countries
🇩🇪 Germany
🇪🇸 Spain
🇮🇹 Italy
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