C. difficile GDH & Toxin A+B Combo Rapid Test

EUDAMED

Class IVD General (EU MDR)

Ref P221115

by Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.

Identity

Trade Name: C. difficile GDH & Toxin A+B Combo Rapid Test EUDAMED
Device Name: C. difficile GDH & Toxin A+B Combo Rapid Test EUDAMED
Model / Reference: P221115 EUDAMED

Identifiers

Primary DI / UDI-DI: 16972698604222 EUDAMED
Basic UDI-DI: B-16972698604222 EUDAMED
EMDN Code: W0105011803 C.DIFFICILE GDH AND TOXIN A/B COMBINED DETECTION 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

Yes

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

EUDAMED

Near-Patient Testing

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

EUDAMED

Surgical Instrument

EUDAMED

C. difficile GDH & Toxin A+B Combo Rapid Test by Hangzhou Genesis Biodetection and Biocontrol Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED

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-16972698604222	Class IVD General	Active

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Manufacturer

Manufacturer: Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.
EUDAMED SRN: CN-MF-000013495
Authorised Representative: CMC Medical Devices & Drugs SL ES-AR-000000293

Sources (1)

EUDAMED c2e94f15-41c8-4de6-b7d7-86fe60ab9bda 61 fields · synced Oct 6, 2026