Eu Ivdd
Eu Ivd Annex 2 List B
On The Market
๐จ๐ณ China
Safe-Accu
Devices (same UDI-DI)
1
Certificates
1
Countries
3
Notified Bodies
1
Basic Information
- Primary DI
- 06934175037391
- Basic UDI-DI Code
- B-06934175037391
- Reference
- 1N002DD
- 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-Accu Blood Glucose Monitoring System is designed for the quantitative measurement of glucose in fresh capilary 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 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 |
|---|---|
| W0201060102 | BLOOD GLUCOSE METERS |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | No.V1 0602500017 | TรV SรD Product Service GmbH | Expired |
Available In Countries
๐ฉ๐ช Germany
๐ช๐ธ Spain
๐ฎ๐น Italy
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