Eu Ivdd
Eu Ivd Annex 2 List B
On The Market
๐จ๐ณ China
Safe AQ Smart
Devices (same UDI-DI)
1
Certificates
1
Countries
3
Notified Bodies
1
Basic Information
- Primary DI
- 06934175037704
- Basic UDI-DI Code
- B-06934175037704
- Reference
- 2J002DD
- 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 blood glucose test strip is used only with Safe AQ Smart,Safe AQ Voice,Safe AQ Air meters to quantitative determine 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. The test strips requires 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 | TรV SรD Product Service GmbH | Expired |
Available In Countries
๐ฉ๐ช Germany
๐ช๐ธ Spain
๐ฎ๐น Italy
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