Eu Ivdd
Eu Ivd Self Testing
On The Market
🇨🇳 China
GLUCOSE TEST STRIPS
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- D-01B0101Y3
- Basic UDI-DI Code
- B-01B0101Y3
- Reference
- 1N003
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Self Testing
- Status
- On The Market
- Manufacturer
- Changsha Sinocare Inc.
Additional Description
The Safe-Accu Blood Glucose Test Strip is intended to be used with the Safe-Accu Blood Glucose Meter to quantitatively measure glucose (sugar) in capillary whole blood samples drawn from the fingertips or venous whole blood samples. The Safe-Accu 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.
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 |
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