Basic UDI-DI
Eu Ivdd
Eu Ivd Self Testing
🇰🇷 South Korea
CERA-CHEK™ Hb Plus Hemoglobin Measuring System
Code: B-08800065152018
Devices
1
Certificates
1
Notified Bodies
1
Auth. Representatives
1
Basic Information
- UDI-DI Code
- B-08800065152018
- Issuing Agency
- EUDAMED
- Device Model
- H 400
- Types
-
Instrument Professional testing Near patient testing Self testing
- Regulation
- Eu Ivdd Legacy
- Classification
- Eu Ivd Self Testing
- Manufacturer
- GC MEDIS Corp.
- Last Updated
- June 11, 2024
Certificate Health
Total
1
Valid
0
Expiring < 6mo
0
Expired / Withdrawn
1
| Type | Number | Expiry Date | Status | |
|---|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | V74 091763 0019 | TÜV SÜD Product Service GmbH | May 26, 2024 |
Associated Devices
This Basic UDI-DI is associated with 1 device.
| Name | Status |
|---|---|
| CERA-CHEK™ Hb Plus Hemoglobin Measuring System | On the market |