BLOOD TEST STRIPS CONTROLS
Let the assistant research this device
The Research Assistant compiles risk class, certificates, notified bodies and related records β and cites every one.
Free to try Β· every answer cites its records
Basic Information
- Primary DI
- D-01A0104XW
- Basic UDI-DI Code
- B-01A0104XW
- Reference
- 2J003; 2J004; 2K002; 2K003
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Annex 2 List B
- Status
- On The Market
- Manufacturer
- Changsha Sinocare Inc.
Additional Description
The Safe AQ Smart, Safe AQ Air, Safe AQ Voice Blood Glucose Monitoring System is designed for the quantitative measurement of glucose in fresh capillary whole blood taken from the fingertip or in venous whole blood samples, The Blood Glucose Monitoring System is for use outside the body only (in vitro diagnostic use) for self-testing and professional use as an aid in the management of diabetes. It is for in vitro diagnostic use only and should not be used for the diagnosis or screening of diabetes.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W010106010801 | BLOOD TEST STRIPS CONTROLS |
| W0101060101 | GLUCOSE TEST STRIPS |
| W0201060102 | BLOOD GLUCOSE METERS |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | No. V1 060250 0017 | TΓV SΓD 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).