Eu Ivdd
Eu Ivd Annex 2 List B
On The Market
🇰🇷 South Korea
CERA-CHEK™ 3 in 1 GHL Blood Glucose Test Strip
Devices (same UDI-DI)
1
Certificates
1
Countries
2
Notified Bodies
1
Basic Information
- Primary DI
- 08800065124022
- Basic UDI-DI Code
- B-08800065124022
- Reference
- M400S10
- 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 Blood Glucose Test Strip is intended to help people manage their diabetes with measuring their glucose level with fresh capillary whole blood from the fingertip for self testing. It also provides professional healthcare personnel with the helpful information with measuring glucose concentration in fresh capillary whole blood as well as fresh venous blood. The CERA-CHEK™ 3 in 1 GHL Blood Glucose Test Strip is intended for in vitro diagnostic use.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0101060101 | GLUCOSE 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
🇱🇹 Lithuania
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