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Multi-Drug Test Panel - BZO

EUDAMED

Class IVD General (EU MDR)

Ref DOA-A154-001

by Hangzhou Aichek Medical Technology Co., Ltd.

Identity

Trade Name
Multi-Drug Test Panel (AMP/OPI/PCP/BAR/MTD/TCA/BZO/TRA/COT/COC/MDMA/THC/MET/MOP/ALC) EUDAMED
Device Name
Multi-Drug Test Panel (AMP/OPI/PCP/BAR/MTD/TCA/BZO/TRA/COT/COC/MDMA/THC/MET/MOP/ALC) EUDAMED
Model / Reference
DOA-A154-001 EUDAMED

Identifiers

Primary DI / UDI-DI
D-DOA-A154-001WN EUDAMED
Basic UDI-DI
B-DOA-A154-001WN EUDAMED
EMDN Code
W0102160511 MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT & POC EUDAMED
Models / Variants
AMP EUDAMED
OPI EUDAMED
PCP EUDAMED
BAR EUDAMED
MTD EUDAMED
TCA EUDAMED
BZO EUDAMED
TRA EUDAMED
COT EUDAMED
COC EUDAMED
MDMA EUDAMED
THC EUDAMED
MET EUDAMED
MOP EUDAMED
ALC 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 Test Panel - BZO by Hangzhou Aichek Medical Technology Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED — 15 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 b1a9c5fa-301e-4db9-bca2-d1239acbcd18 61 fields · synced Oct 6, 2026