Eu Ivdd
Eu Ivd Self Testing
On The Market
🇨🇳 China
Mission Ultra Hemoglobin Testing System
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- D-C111-6011RN
- Basic UDI-DI Code
- B-C111-6011RN
- Reference
- C111-6011
- 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 Mission 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 Mission Ultra Hemoglobin Testing System consists of Mission Ultra Hemoglobin Meter, Mission Ultra Hemoglobin Test Strips and Mission Ultra Hemoglobin Control Solution, and it is for self-testing and professional use.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0101060199 | BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - OTHER |
| W010106010801 | BLOOD TEST STRIPS CONTROLS |
| W0201069099 | VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - 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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