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PCT/IL-6 Rapid Test (FIA)

EUDAMED

Class IVD General (EU MDR)

Ref P232102

by Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.

Identity

Trade Name: PCT/IL-6 Rapid Test (FIA) EUDAMED
Device Name: PCT/IL-6 Rapid Test (FIA) EUDAMED
Model / Reference: P232102 EUDAMED

Identifiers

Primary DI / UDI-DI: 16972698600170 EUDAMED
Basic UDI-DI: B-16972698600170 EUDAMED
EMDN Code: W0102069013,W01030609 EUDAMED

Classification

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

Clinical & Handling

Sterile

Yes

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

Yes

EUDAMED

Microbial Substances

No

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

PCT/IL-6 Rapid Test (FIA) 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

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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 e20ae8e8-a96d-4a6e-b23b-021462a02369 61 fields · synced Jun 18, 2026