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iMOST-U Hematology Q-card
EUDAMEDClass IVD General (EU MDR)
Ref 017Model UQ001Ref UQ001050
Identity
- Device Name
- iMOST-U Hematology Q-card EUDAMED
- Model / Reference
- UQ001 EUDAMED017 EUDAMEDUQ001050 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976894950179 EUDAMED
- Basic UDI-DI
- B-06976894950179 EUDAMED
- EMDN Code
- W0103010103 COMPLETE CELL COUNT EUDAMEDW0103010699 HAEMATOLOGY RAPID TESTS & POINT OF CARE - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
iMOST-U Hematology Q-card by Essenlix Biotechnology (Shanghai) Co., Ltd — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06976894950179 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Essenlix Biotechnology (Shanghai) Co., Ltd
- EUDAMED SRN
- CN-MF-000038839
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (2)
- EUDAMED 32cfb832-6d99-481b-bb10-dc475dc61b53 61 fields · synced Jun 19, 2026
- EUDAMED 665b726e-8f3e-4ade-a916-6dfb7df3c7ac 61 fields · synced Jun 19, 2026