Eu Ivdd
Eu Ivd Annex 2 List B
On The Market
🇰🇷 South Korea
CERA-CHEK™ 1070 Blood Glucose Test Strip
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- 08800065130122
- Basic UDI-DI Code
- B-08800065130122
- Reference
- G300S10
- 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™ 1070 Blood Glucose Test Strip is intended for use with the CERA-CHEK™ 1070 Blood Glucose Monitoring System for self-testing by lay person with diabetes and for near-patient testing by healthcare professionals to quantitatively measure glucose in venous blood and fresh capillary whole blood drawn from the fingertips.
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 |
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