Eu Ivdd
Eu Ivd Self Testing
On The Market
🇨🇳 China
Blood Glucose Test Strips
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- 06921807610237
- Basic UDI-DI Code
- B-06921807610237
- Reference
- GL0825
- Device Types
-
Single use Sterilization
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Self Testing
- Status
- On The Market
- Manufacturer
- Beijing Lepu Medical Technology Co., Ltd.
Additional Description
The Blood Glucose Test Strip is used for in vitro quantitative detection of glucose in fresh capillary whole blood from the finger. It can be intended for professional use or self-testing by patient (or their families) at home or in medical facilities as an aid to monitor the effectiveness control of glucose in patient blood sample. It should not be used for the diagnosis of or screening for the related diseases. It should not be used as the basis for the adjustment of therapeutic drugs
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0101060101 | GLUCOSE TEST STRIPS |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | HL2062714-1 | TÜV Rheinland LGA Products GmbH | Expired |
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