Eu Ivdd
Eu Ivd Annex 2 List B
On The Market
🇰🇷 South Korea
CERA-CHEK™ 3 in 1 GHL Blood Glucose, Hemoglobin, Lactate Monitoring System
Devices (same UDI-DI)
1
Certificates
1
Countries
2
Notified Bodies
1
Basic Information
- Primary DI
- 08800065113019
- Basic UDI-DI Code
- B-08800065113019
- Reference
- M400M10
- Device Types
- None provided
- 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 Blood Glucose, Hemoglobin, Lactate Monitoring System is intended to help people manage their glucose, hemoglobin and lactate level. It also provides healthcare professionals with helpful information by measuring glucose, hemoglobin and lactate in fresh capillary whole blood as well as venous blood.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0201060102 | BLOOD GLUCOSE METERS |
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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