Drugs of Abuse Rapid Test Cassette(Hair)

EUDAMED

Class IVD General (EU MDR)

Ref GBDOA-11X5

by Zhejiang Orient Gene Biotech Co., Ltd

Identity

Trade Name: Drugs of Abuse Rapid Test Cassette(Hair) EUDAMED
Device Name: Drugs of Abuse Rapid Test Cassette(Hair) EUDAMED
Model / Reference: GBDOA-11X5 EUDAMED

Identifiers

Primary DI / UDI-DI: D-GBDOA-11X5TW EUDAMED
Basic UDI-DI: B-GBDOA-11X5TW EUDAMED
EMDN Code: W0102090199 DRUGS OF ABUSE - OTHER EUDAMED

Classification

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

Clinical & Handling

Sterile

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

Yes

EUDAMED

Microbial Substances

EUDAMED

Reagent

EUDAMED

Self Testing

EUDAMED

Near-Patient Testing

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

EUDAMED

Surgical Instrument

EUDAMED

Drugs of Abuse Rapid Test Cassette(Hair) by Zhejiang Orient Gene Biotech 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

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/IVDD	B-GBDOA-11X5TW	Class IVD General	Active

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Manufacturer

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
EUDAMED SRN: CN-MF-000017965
Authorised Representative: CMC Medical Devices & Drugs SL ES-AR-000000293

Sources (1)

EUDAMED d8f800b5-fd66-4e25-80cd-fd9e0dc48e4a 61 fields · synced Jun 19, 2026