Eu Ivdd
Eu Ivd Annex 2 List B
On The Market
🇹🇼 Taiwan
GlucoLeader Enhance Blood Glucose Monitoring System
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- 04711200723946
- Basic UDI-DI Code
- B-04711200723946
- Reference
- 3K-01-250062
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Annex 2 List B
- Status
- On The Market
- Manufacturer
- HMD Biomedical Inc.
Additional Description
GlucoLeader Enhance KIT with 25Strips and GCS(Es)
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0101050205 | DIABETES CONTROLS |
| W0101060101 | GLUCOSE TEST STRIPS |
| W0201060102 | BLOOD GLUCOSE METERS |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | No. V1 097447 0006 | TÜV SÜD Product Service GmbH | Expired |
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