Eu Ivdd
Eu Ivd Annex 2 List B
On The Market
🇨🇳 China
On Call Extra Blood Glucose Monitoring System
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- D-G115-10HJ3
- Basic UDI-DI Code
- B-G115-10HJ3
- Reference
- G115-10H
- 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 Blood Glucose Monitoring System is intended for quantitative measurement of glucose in fresh capillary whole blood from the finger, forearm and palm to monitor daily blood glucose for individuals who have diabetes or are potentially at risk for diabetes. The system includes On Call Extra Blood Glucose Meters, On Call Extra Blood Glucose Test Strips and On Call Extra Glucose Control Solution.
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) | V1 042074 0026 | TÜV SÜD Product Service GmbH | Expired |
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