One Step EDDP Test Cassette (Urine)

EUDAMED

Class IVD General (EU MDR)

Ref GBEDD-102a

by Zhejiang Orient Gene Biotech Co., Ltd

Identity

Trade Name: One Step EDDP Test Cassette (Urine) EUDAMED
Device Name: One Step EDDP Test Cassette (Urine) EUDAMED
Model / Reference: GBEDD-102a EUDAMED

Identifiers

Primary DI / UDI-DI: D-GBEDD-102aNM EUDAMED
Basic UDI-DI: B-GBEDD-102aNM EUDAMED
EMDN Code: W0102090120 EDDP SPECIFIC (METHADONE METABOLITES) EUDAMED

Classification

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

One Step EDDP Test Cassette (Urine) 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-GBEDD-102aNM	Class IVD General	Active

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Manufacturer

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
EUDAMED SRN: CN-MF-000017965
Authorised Representative: Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Sources (1)

EUDAMED 2e64c6fa-d3d8-4320-86ee-9f648266f86c 61 fields · synced Jul 22, 2026