Eu Ivdd
Eu Ivd Self Testing
On The Market
🇨🇳 China
Mission Ultra Hemoglobin Test Strips
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- D-C131-6011SQ
- Basic UDI-DI Code
- B-C131-6011SQ
- Reference
- C131-6011
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Self Testing
- Status
- On The Market
- Manufacturer
- Acon Biotech (Hangzhou) Co., Ltd.
Additional Description
The Mission Ultra Hemoglobin Test Strips are intended to use with Mission Ultra Hemoglobin Meter for the quantitative determination of Hemoglobin (Hb) and Hematocrit (Hct) in fresh fingertip capillary or venous whole bloo. The Mission Ultra Hemoglobin Test Strips is for self-testing and professional use.
CND Nomenclature Codes
| Code | Description |
|---|---|
| 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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