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iMOST-L Hematology Q-card
EUDAMEDClass IVD General (EU MDR)
Ref 002Model LQ001Ref 008Ref 005Ref 011Ref LQ001010Ref LQ001025Ref LQ001050Ref LQ001100
Identity
- Device Name
- iMOST-L Hematology Q-card EUDAMED
- Model / Reference
- LQ001 EUDAMED002 EUDAMED008 EUDAMED005 EUDAMED011 EUDAMEDLQ001010 EUDAMEDLQ001025 EUDAMEDLQ001050 EUDAMEDLQ001100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976894950025 EUDAMED06976894950087 EUDAMED06976894950056 EUDAMED06976894950117 EUDAMED
- Basic UDI-DI
- B-06976894950025 EUDAMEDB-06976894950087 EUDAMEDB-06976894950056 EUDAMEDB-06976894950117 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-L 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-06976894950025 | 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 (8)
- EUDAMED f6c51816-905f-436f-9e11-ba96be1c9cc5 61 fields · synced Jul 21, 2026
- EUDAMED 4f9b26d4-8558-497e-934e-aef9d7a22235 61 fields · synced May 17, 2026
- EUDAMED 35f87012-cb5d-4b57-92a2-d7e410487b91 61 fields · synced May 17, 2026
- EUDAMED fca9572e-0b8c-4cf1-861d-9dd6d685cda1 61 fields · synced May 17, 2026
- EUDAMED f18f1304-a94f-4d6b-afee-71f130ebbfec 61 fields · synced Jul 11, 2026
- EUDAMED ea0a7a16-2439-4783-997c-4da62060ea37 61 fields · synced Jul 12, 2026
- EUDAMED 603551f2-b831-4c05-8015-81d1fa5c085c 61 fields · synced Jul 13, 2026
- EUDAMED a379f5aa-15fe-45ea-b6db-afc378b3ef4b 61 fields · synced Jul 21, 2026