Eu Ivdd
Eu Ivd Annex 2 List B
On The Market
🇨🇳 China
On Call Sure Glucose Control Solution
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- D-G125-12UKG
- Basic UDI-DI Code
- B-G125-12UKG
- Reference
- G125-12U
- 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 Sure Glucose Control Solution contains a known concentration of glucose. It is used to confirm that your On Call Sure Blood Glucose Test Strips are working properly when used with On Call Sure family of blood glucose meters or On Call GU Dual Blood Glucose & Uric Acid Meter and to confirm that you are performing the test correctly. The On Call Sure family of blood glucose meters include On Call Sure Blood Glucose Meter and On Call Sure Sync Blood Glucose Meter.
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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