Eu Ivdd
Eu Ivd Self Testing
On The Market
🇨🇳 China
On Call GU Dual Blood Glucose and Uric Acid Meter
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- D-GU114-11DK5
- Basic UDI-DI Code
- B-GU114-11DK5
- Reference
- GU114-11D
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Self Testing
- Status
- On The Market
- Manufacturer
- Acon Biotech (Hangzhou) Co., Ltd.
Additional Description
The On Call GU Dual Blood Glucose & Uric Acid Meter is intended for quantitative assay for the detection of glucose in fresh capillary whole blood samples obtained from the fingertip, forearm, and/or palm, as well as healthcare professional use with fresh neonatal whole blood samples and fresh venous whole blood samples., and quantitative assay for the detection of uric acid in fresh capillary whole blood samples obtained from the fingertip, as well as healthcare professional use with fresh venous whole blood samples.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0201069099 | VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER |
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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