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Multi-drug Combined Rapid Test Cassette (Colloidal Gold Method)

EUDAMED

Class IVD General (EU MDR)

Ref IH011

by Beijing Applied Biological Technologies Co., Ltd.

Identity

Device Name
Multi-drug Combined Rapid Test Cassette (Colloidal Gold Method) EUDAMED
Model / Reference
IH011 EUDAMED

Identifiers

Primary DI / UDI-DI
06979502240082 EUDAMED
Basic UDI-DI
B-06979502240082 EUDAMED
EMDN Code
W0102090199 DRUGS OF ABUSE - OTHER EUDAMED

Classification

Device Class
Class IVD General EUDAMED
Market of Registration
Germany 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

Multi-drug Combined Rapid Test Cassette (Colloidal Gold Method) by Beijing Applied Biological Technologies Co., Ltd. — Class IVD General — IVDD — listed in…

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDD

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Manufacturer

EUDAMED SRN
CN-MF-000012338
Authorised Representative
Luxus Lebenswelt GmbH DE-AR-000005110

Sources (1)

  • EUDAMED e6aa1d39-e4da-4096-a2fc-e4a199a2497c 61 fields · synced Sep 18, 2026