Eu Ivdd
Eu Ivd Annex 2 List B
On The Market
🇰🇷 South Korea
CERA-CHEK™ 3 in 1 GHL Lactate Control Solution
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- 08800065181209
- Basic UDI-DI Code
- B-08800065181209
- Reference
- M400C12
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Annex 2 List B
- Status
- On The Market
- Manufacturer
- GC MEDIS Corp.
Additional Description
CERA-CHEK™ 3 in 1 GHL Lactate Control Solution is able to check that the test meter and the test strips are working together as a system and that you are performing the test correctly. It is very important that you do this simple check routinely to make sure you get accurate results.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0101050299 | SPECIFIC CONTROLS (CC) - OTHER |
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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