Eu Ivdd
Eu Ivd Self Testing
On The Market
🇰🇷 South Korea
CERA-CHEK™ Hb Plus Hemoglobin Control Solution
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- 08800065170005
- Basic UDI-DI Code
- B-08800065170005
- Reference
- B400C10
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Self Testing
- Status
- On The Market
- Manufacturer
- GC MEDIS Corp.
Additional Description
CERA-CHEK™ Hb Plus Hemoglobin Control Solution is an assayed quality control solutions intended for use in self-testing by lay person and for near-patient testing by healthcare professionals as a quantitative quality monitoring the performance of CERA-CHEK™ Hb Plus Hemoglobin Measuring System.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0103010504 | HAEMOGLOBIN CONTROLS |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | V1 091763 0015 | TÜV SÜD Product Service GmbH | Expired |
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