Eu Ivdd
Eu Ivd Self Testing
On The Market
🇨🇳 China
Mission Ultra Hemoglobin Control Solution
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- D-C121-6011S7
- Basic UDI-DI Code
- B-C121-6011S7
- Reference
- C121-6011
- 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 Control Solution contains a known concentration of hemoglobin. It is used to confirm the Mission Ultra Hemoglobin Test Strips and Mission Ultra Hemoglobin Meter are working together properly and the test is being performed correctly. It is for self-testing and professional use.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W010106010801 | BLOOD TEST STRIPS CONTROLS |
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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