Eu Ivdd
Eu Ivd Annex 2 List B
On The Market
๐น๐ผ Taiwan
Mylife Unio Cara Blood Glucose Monitoring System
Devices (same UDI-DI)
1
Certificates
1
Countries
8
Notified Bodies
1
Basic Information
- Primary DI
- D-GM775V6
- Basic UDI-DI Code
- B-GM775V6
- Reference
- 775G01
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Annex 2 List B
- Status
- On The Market
- Manufacturer
- Bionime Corporation
Additional Description
Meter, Strips(10pcs), Glucose control(Normal)
CND Nomenclature Codes
| Code | Description |
|---|---|
| W01010699 | CLIN. CHEM. RT & POC - OTHER |
| W0101060101 | GLUCOSE TEST STRIPS |
| W0201060102 | BLOOD GLUCOSE METERS |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | HL 2110160-1 | TรV Rheinland LGA Products GmbH | Expired |
Available In Countries
๐ฉ๐ช Germany
๐ฉ๐ฐ Denmark
๐ซ๐ฎ Finland
๐ซ๐ท France
๐ฎ๐น Italy
๐ณ๐ฑ Netherlands
๐ณ๐ด Norway
๐ธ๐ฎ Slovenia
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