Eu Ivdd
Eu Ivd Annex 2 List B
On The Market
🇰🇷 South Korea
CERA-CHEK™ 3 in 1 GHL Hemoglobin Control Solution
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- 08800065170203
- Basic UDI-DI Code
- B-08800065170203
- Reference
- M400C11
- 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 Hemoglobin Control Solution is provided in two levels for monitoring system performance at significant points within the clinical range. It is packaged in bottles, each containing 3.0mL of Control Solution. Bottles are packaged 2 (per) box.
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 |
Similar Devices
Other on-the-market devices with the same classification (Eu Ivd Annex 2 List B) and regulation (EU IVDD).
master diagnostica
Device
EU IVDD
·
Eu Ivd Annex 2 List B
·VITRO, S.A.·On the market
Vitamin B1 & B6 Reagent Set
Device
EU IVDD
·
Eu Ivd Annex 2 List B
·Diagnotix B.V.·On the market·32 countries
Methylmalonic Acid Reagent Set
Device
EU IVDD
·
Eu Ivd Annex 2 List B
·Diagnotix B.V.·On the market·32 countries
Cortisol & Cortisone Reagent Set
Device
EU IVDD
·
Eu Ivd Annex 2 List B
·Diagnotix B.V.·On the market·32 countries
Vitamin A & E Reagent Set
Device
EU IVDD
·
Eu Ivd Annex 2 List B
·Diagnotix B.V.·On the market·32 countries
Metanephrines Reagent Set
Device
EU IVDD
·
Eu Ivd Annex 2 List B
·Diagnotix B.V.·On the market