Monkeypox Ag Rapid Test Cassette (Swab)

EUDAMED

Class IVD General (EU MDR)

Ref GCMKP-502b

by Zhejiang Orient Gene Biotech Co., Ltd

Identity

Trade Name: Monkeypox Ag Rapid Test Cassette (Swab) EUDAMED
Device Name: Monkeypox Ag Rapid Test Cassette (Swab) EUDAMED
Model / Reference: GCMKP-502b EUDAMED

Identifiers

Primary DI / UDI-DI: D-GCMKP-502b5Q EUDAMED
Basic UDI-DI: B-GCMKP-502b5Q EUDAMED
EMDN Code: W0105099008 MONKEYPOX VIRUS / MPOX RT & POC 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

Yes

EUDAMED

Self Testing

EUDAMED

Near-Patient Testing

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

EUDAMED

Surgical Instrument

EUDAMED

Monkeypox Ag Rapid Test Cassette (Swab) 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-GCMKP-502b5Q	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 8f4f368d-9c37-42ea-b4fe-906d2dd5f609 61 fields · synced Jun 19, 2026