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iMOST-U Hematology Analyzer
EUDAMEDClass A (EU MDR)
Ref 105Model UA001Ref UA001001
Identity
- Device Name
- iMOST-U Hematology Analyzer EUDAMED
- Model / Reference
- UA001 EUDAMED105 EUDAMEDUA001001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976894951053 EUDAMED
- Basic UDI-DI
- 697689495UA001UZ EUDAMED
- Direct Marketing DI
- 06976894951053 EUDAMED
- EMDN Code
- W0202010202 SEMI-AUTOMATED HEMATOLOGY ANALYSERS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
Yes
EUDAMED
iMOST-U Hematology Analyzer by Essenlix Biotechnology (Shanghai) Co., Ltd — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 697689495UA001UZ | Class A | 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 b38d5842-88f3-4628-9048-710d7578941d 61 fields · synced Jul 10, 2026
- EUDAMED fad1db35-2cf2-4ada-89f6-ca7d9e8e1702 61 fields · synced Jul 10, 2026