H. pylori Ag Rapid Test Cassette (Feces)

EUDAMED

Class IVD General (EU MDR)

Ref GCHP-602a，GCHP-602Ca

by Zhejiang Orient Gene Biotech Co., Ltd

Identity

Trade Name: H. pylori Ag Rapid Test Cassette (Feces) EUDAMED
Device Name: H. pylori Ag Rapid Test Cassette (Feces) EUDAMED
Model / Reference: GCHP-602a，GCHP-602Ca EUDAMED

Identifiers

Primary DI / UDI-DI: D-GCHP-602CJ EUDAMED
Basic UDI-DI: B-GCHP-602CJ EUDAMED
EMDN Code: W0105010401 H. PYLORI ANTIGEN DETECTION 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

H. pylori Ag Rapid Test Cassette (Feces) 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-GCHP-602CJ	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 43a16149-913d-4ff1-b54a-5d39b1c4f215 61 fields · synced Oct 6, 2026