Eu Ivdd
Eu Ivd Annex 2 List B
No Longer On The Market
🇹🇼 Taiwan
GlucoLeader Enhance 2 Blood Glucose Monitoring System
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- 04711200722109
- Basic UDI-DI Code
- B-04711200722109
- Reference
- 3K-01-250081 / 3K-01-250082
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Annex 2 List B
- Status
- No Longer On The Market
- Manufacturer
- HMD Biomedical Inc.
Additional Description
GlucoLeader Enhance 2 Meter and KIT(for Republic of Türkiye)
CND Nomenclature Codes
| Code | Description |
|---|---|
| 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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