Eu Ivdd
Eu Ivd Annex 2 List B
On The Market
🇨🇳 China
On Call Extra Glucose Control Solution
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- D-G125-12HJN
- Basic UDI-DI Code
- B-G125-12HJN
- Reference
- G125-12H
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Annex 2 List B
- Status
- On The Market
- Manufacturer
- Acon Biotech (Hangzhou) Co., Ltd.
Additional Description
The On Call Extra Glucose Control Solution contains a known concentration of glucose. It is used to confirm that your On Call Extra Blood Glucose Test Strips and On Call Extra Blood Glucose Meters are working together properly and that you are performing the test correctly.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W010106010801 | BLOOD TEST STRIPS CONTROLS |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | No. V1 042074 0026 | TÜV SÜD Product Service GmbH | Expired |
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