Eu Ivdd
Eu Ivd Self Testing
On The Market
🇨🇳 China
QUIK-CHECK Ultra Hemoglobin Testing System
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- D-C111-6017S2
- Basic UDI-DI Code
- B-C111-6017S2
- Reference
- C111-6017
- 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 QUIK-CHECK Ultra Hemoglobin Testing System is intended for the quantitative determination of Hemoglobin (Hb) and Hematocrit (Hct) in fresh fingertip capillary or venous whole blood. The QUIK-CHECKT Ultra Hemoglobin Testing System consists of QUIK-CHECK Ultra Hemoglobin Meter, QUIK-CHECK Ultra Hemoglobin Test Strips and QUIK-CHECK Ultra Hemoglobin Control Solution, and it is for self-testing and professional use.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0201069099 | VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER |
| W010106010801 | BLOOD TEST STRIPS CONTROLS |
| W0101060199 | BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - OTHER |
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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