Eu Ivdd
Eu Ivd Annex 2 List B
On The Market
🇨🇳 China
On Call Sure Blood Glucose Test Strips
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- D-G135-10UKP
- Basic UDI-DI Code
- B-G135-10UKP
- Reference
- G135-10U
- Device Types
-
Single use
- 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 Blood Glucose Test Strips are intended to work with the On Call Sure family of blood glucose meters and On Call GU Dual Blood Glucose & Uric Acid Meter 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 |
|---|---|
| W0101060101 | GLUCOSE TEST STRIPS |
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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