CERA-CHEK™ 1070 Blood Glucose Monitoring System
Basic Information
- Primary DI
- 08800065110001
- Basic UDI-DI Code
- B-08800065110001
- Reference
- G300M10
- 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™ 1070 Blood Glucose Monitoring System, comprising the blood glucose meter, the compatible test strips, and control solutions, is an automated system intended for the quantitative measurement of glucose in venous blood and fresh capillary whole blood drawn from the fingertips. The System is intended to be used for self-testing by lay persons with diabetes and for near-patient testing by healthcare professionals to monitor the effectiveness of diabetes control. The CERA-CHEK™ 1070 Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes or for neonatal use. The system is intended for in vitro diagnostic use only.
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 |
Similar Devices
Other on-the-market devices with the same classification (Eu Ivd Annex 2 List B) and regulation (EU IVDD).