Eu Ivdd
Eu Ivd Annex 2 List B
On The Market
🇰🇷 South Korea
CERA-CHEK™ 3 in 1 GHL Hemoglobin Test Strip
Devices (same UDI-DI)
1
Certificates
1
Countries
2
Notified Bodies
1
Basic Information
- Primary DI
- 08800065140220
- Basic UDI-DI Code
- B-08800065140220
- Reference
- M400S11
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Annex 2 List B
- Status
- On The Market
- Manufacturer
- GC MEDIS Corp.
Additional Description
The CERA-CHEK™ 3 in 1 GHL Hemoglobin Test Strip is intended to help people manage their hemoglobin level. It also provides professional healthcare personnel with helpful information by measuring hemoglobin in fresh capillary whole blood as well as venous blood. The CERA-CHEK™ 3 in 1 GHL Hemoglobin Test Strip is intended for in vitro diagnostic use.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0103010201 | HAEMOGLOBIN DETERMINATIONS (TOTAL HB) |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | V1 091763 0015 | TÜV SÜD Product Service GmbH | Expired |
Available In Countries
🇧🇪 Belgium
🇱🇹 Lithuania
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