Eu Ivdd
Eu Ivd Self Testing
On The Market
🇨🇳 China
BLOOD GLUCOSE METERS
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
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Basic Information
- Primary DI
- D-01A0111XT
- Basic UDI-DI Code
- B-01A0111XT
- Reference
- 5Y001, 5Z001, 6A001, 6B001, 6C001, 6D001
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Self Testing
- Status
- On The Market
- Manufacturer
- Changsha Sinocare Inc.
Additional Description
The Safe AQ max and 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). lt 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.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0201060102 | BLOOD GLUCOSE METERS |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | No. V1060250 0017 | TÜV SÜD Product Service GmbH | Expired |
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