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Basic Information
- Primary DI
- 06934175004591
- Basic UDI-DI Code
- B-06934175004591
- Reference
- 5Y001DD
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Annex 2 List B
- Status
- On The Market
- Manufacturer
- Changsha Sinocare Inc.
Additional Description
The Safe AQ pro series blood glucose monitoring system is intended for use in the quantitative measurement of glucose in human whole blood taken from the fingertip (capillary) or from the vein (venous). it is intended to be used by people with diabetes at home or clinical site as an aid in monitoring the effectiveness of their diabetes control programs. The blood glucose monitoring system is for in vitro diagnostic use only. lt is not intended for the diagnosis of, or screening for diabetes. lt is not intended for use on neonates.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0201060102 | BLOOD GLUCOSE METERS |
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
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