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-01A0102XS
- Basic UDI-DI Code
- B-01A0102XS
- Reference
- 5D001
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Self Testing
- Status
- On The Market
- Manufacturer
- Changsha Sinocare Inc.
Additional Description
The Safe-Accu 2 Blood Glucose Monitoring System is designed for the quantitative measurement of glucose in fresh capillary whole blood samples taken from the fingertip and in venous whole blood samples. The Blood Glucose Monitoring System is for use outside the body only (in vitro diagnostic use) for self-testing and professional use as an aid in the management of diabetes. The Safe-Accu 2 Blood Glucose Monitoring System is intended for in vitro diagnostic use and should not be used for the diagnosis of or screening of diabetes.
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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