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Multi-Drug Rapid Test - THC

EUDAMED

Class IVD General (EU MDR)

Ref DOA-J33-004

by Hangzhou Aichek Medical Technology Co., Ltd.

Identity

Trade Name: Multi-Drug Rapid Test (Saliva) (COC/THC/AMP) EUDAMED
Device Name: Multi-Drug Rapid Test (Saliva) (COC/THC/AMP) EUDAMED
Model / Reference: DOA-J33-004 EUDAMED

Identifiers

Primary DI / UDI-DI: D-DOA-J33-0049U EUDAMED
Basic UDI-DI: B-DOA-J33-0049U EUDAMED
EMDN Code: W0102160511 MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT & POC EUDAMED
Models / Variants: COC EUDAMED
THC EUDAMED
AMP EUDAMED

Classification

Device Class: Class IVD General EUDAMED
Market of Registration: Spain EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

Yes

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

Multi-Drug Rapid Test - THC by Hangzhou Aichek Medical Technology Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED — 3 models

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDD

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Manufacturer

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
EUDAMED SRN: CN-MF-000028093
Authorised Representative: Medunion S.L. ES-AR-000019366

Sources (1)

EUDAMED 03b4bc59-e787-4451-b3e7-edcbe765f2f2 61 fields · synced Jul 29, 2026