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iMOST-U Hematology Q-card

EUDAMED

Class IVD General (EU MDR)

Ref 023Model UQ001Ref 014Ref 020Ref UQ001010Ref UQ001100

by Essenlix Biotechnology (Shanghai) Co., Ltd

Identity

Device Name
iMOST-U Hematology Q-card EUDAMED
Model / Reference
UQ001 EUDAMED
023 EUDAMED
014 EUDAMED
020 EUDAMED
UQ001010 EUDAMED
UQ001100 EUDAMED

Identifiers

Primary DI / UDI-DI
06976894950230 EUDAMED
06976894950148 EUDAMED
06976894950209 EUDAMED
Basic UDI-DI
B-06976894950230 EUDAMED
B-06976894950148 EUDAMED
B-06976894950209 EUDAMED
EMDN Code
W0103010103 COMPLETE CELL COUNT EUDAMED
W0103010699 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

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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 (5)

  • EUDAMED 36fa6d41-5dbf-425e-b3f2-646aff577e57 61 fields · synced Jul 23, 2026
  • EUDAMED 72f6cd5c-1a91-4fda-b661-814e1959c010 61 fields · synced May 18, 2026
  • EUDAMED 650d21ec-f9db-492b-86ca-4d1fe770c3fc 61 fields · synced May 19, 2026
  • EUDAMED 7463b4e2-2ae3-4a5d-b85b-44129b2de9a3 61 fields · synced Jul 11, 2026
  • EUDAMED 2012aef6-9591-4c57-8f74-b9fdb8e21cce 61 fields · synced Jul 23, 2026