Eu Ivdd
Eu Ivd Self Testing
On The Market
🇨🇳 China
Blood Glucose Monitoring System
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- 06921807600269
- Basic UDI-DI Code
- B-06921807600269
- Reference
- JY06poctor800
- 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
Poctor 800 glucometer co-operates with Poctor 800 blood glucose testing strips produced by Beijing Lepu Medical Technology Co., Ltd., applied toquantitatively detect the glucose concentration with whole blood sample from fingertip. This product is only used to supervise the effect of diabetes’ blood glucosecontrol.Do not use it to diagnose or screen diabetes, nor as the basis of therapeutic or drug adjustment.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0201060102 | BLOOD GLUCOSE METERS |
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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