GLUCOSE TEST STRIPS
Basic Information
- Primary DI
- D-01B0103Y7
- Basic UDI-DI Code
- B-01B0103Y7
- Reference
- 2B002
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Self Testing
- Status
- On The Market
- Manufacturer
- Changsha Sinocare Inc.
Additional Description
The Safe AQ Angel Blood Glucose Monitoring System is intended for use outside the body (in vitro diagnostic use and should not be used for the diagnosis of or screening of diabetes. The Safe AQ Angel Blood Glucose Test Strip is intended to be used with the Safe AQ ANGEL Blood Glucose Meter to quantitatively measure glucose (sugar) in capillary whole blood samples drawn from the fingertips or venous whole blood samples. The Safe AQ Angel Blood Glucose Test Strip is intended for use by people with diabetes mellitus in the home and by healthcare professionals in clinical setting as an aid in monitoring the effectiveness of diabetes control. The Test Strip requires No Coding.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0101060101 | GLUCOSE TEST STRIPS |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | No. V1 060250 0017 | TÜV SÜD Product Service GmbH | Expired |
Similar Devices
Other on-the-market devices with the same classification (Eu Ivd Self Testing) and regulation (EU IVDD).