Basic UDI-DI
Eu Ivdd
Eu Ivd Annex 2 List B
🇹🇼 Taiwan
GlucoLeader
Code: B-04711200722116
Devices
1
Certificates
1
Notified Bodies
1
Auth. Representatives
1
Basic Information
- UDI-DI Code
- B-04711200722116
- Issuing Agency
- EUDAMED
- Device Model
- Enhance 2
- Types
-
Kit Professional testing Near patient testing Self testing Reagent
- Regulation
- Eu Ivdd Legacy
- Classification
- Eu Ivd Annex 2 List B
- Manufacturer
- HMD Biomedical Inc.
- Last Updated
- April 25, 2025
Certificate Health
Total
1
Valid
0
Expiring < 6mo
0
Expired / Withdrawn
1
| Type | Number | Expiry Date | Status | |
|---|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | No. V1 097447 0006 | TÜV SÜD Product Service GmbH | May 26, 2024 |
Associated Devices
This Basic UDI-DI is associated with 1 device.
| Name | Status |
|---|---|
| GlucoLeader Enhance 2 Blood Glucose Test Strip | No longer on the market |