Eu Ivdd
Eu Ivd Self Testing
On The Market
🇰🇷 South Korea
CERA-CHEK™ Lactate Measuring System
Devices (same UDI-DI)
1
Certificates
1
Countries
2
Notified Bodies
1
Basic Information
- Primary DI
- 08800065158201
- Basic UDI-DI Code
- B-08800065158201
- Reference
- L400M10
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Self Testing
- Status
- On The Market
- Manufacturer
- GC MEDIS Corp.
Additional Description
The CERA-CHEK™ Lactate Measuring System is intended to help people manage their lactate level. It also provides healthcare professionals with helpful information by measuring Lactate in fresh capillary whole blood as well as venous blood. The CERACHEK™ Lactate Test Strip is intended for in vitro diagnostic use.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W02010199 | CHEMISTRY INSTRUMENTS - OTHER |
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
🇪🇸 Spain
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