Eu Ivdd
Eu Ivd Annex 2 List B
On The Market
🇨🇳 China
On Call Sure Sync Blood Glucose Meter
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- D-G115-13WKA
- Basic UDI-DI Code
- B-G115-13WKA
- Reference
- G115-13W
- 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 Sync Blood Glucose Meter is intended to work with the On Call Sure blood glucose test strips for quantitative measurement of glucose in venous, arterial, neonatal or fresh capillary whole blood from the fingertip, forearm and palm to monitor daily blood glucose for individuals who have diabetes or are potentially at risk for diabetes.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0201060102 | BLOOD GLUCOSE METERS |
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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