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Multi-Drug Test Cup - K3

EUDAMED

Class IVD General (EU MDR)

Ref DOA-A157-002

by Hangzhou Aichek Medical Technology Co., Ltd.

Identity

Trade Name
Multi-Drug Test Cup (MET/COC/OXY/MOP/BZO/KET/THC/TRA/K2/K3/K4/MCAT/FTY/MTD/MDMA) EUDAMED
Device Name
Multi-Drug Test Cup (MET/COC/OXY/MOP/BZO/KET/THC/TRA/K2/K3/K4/MCAT/FTY/MTD/MDMA) EUDAMED
Model / Reference
DOA-A157-002 EUDAMED

Identifiers

Primary DI / UDI-DI
D-DOA-A157-002XR EUDAMED
Basic UDI-DI
B-DOA-A157-002XR EUDAMED
EMDN Code
W0102160511 MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT & POC EUDAMED
Models / Variants
MET EUDAMED
COC EUDAMED
OXY EUDAMED
MOP EUDAMED
BZO EUDAMED
KET EUDAMED
THC EUDAMED
TRA EUDAMED
K2 EUDAMED
K3 EUDAMED
K4 EUDAMED
MCAT EUDAMED
FTY EUDAMED
MTD EUDAMED
MDMA 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 Cup - K3 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 9661e75b-6ac6-4ff6-a3bd-0924b8e75a26 61 fields · synced Oct 6, 2026