Eu Ivdd
Eu Ivd Self Testing
On The Market
🇰🇷 South Korea
CERA-CHEK™ Lactate Test Strip
Devices (same UDI-DI)
1
Certificates
1
Countries
2
Notified Bodies
1
Basic Information
- Primary DI
- 08800065133024
- Basic UDI-DI Code
- B-08800065133024
- Reference
- L400S10
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Self Testing
- Status
- On The Market
- Manufacturer
- GC MEDIS Corp.
Additional Description
The CERA-CHEK™ Lactate Test Strip is intended to help people manage their lactate level. It also provides professionals healthcare personnel with helpful information by measuring Lactate in fresh capillary whole blood as well as venous blood. The CERA-CHEK™ Lactate Test Strip is intended for in vitro diagnostic use.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0101060104 | LACTATE TEST STRIPS |
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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