Syphilis Rapid Test Kit (Colloidal Gold Method)

EUDAMED

Class IVD General (EU MDR)

Ref Syphilis Rapid Test Kit (Colloidal Gold Method)

by Farmasino Medical Co., Ltd

Identity

Device Name: Syphilis Rapid Test Kit (Colloidal Gold Method) EUDAMED
Model / Reference: Syphilis Rapid Test Kit (Colloidal Gold Method) EUDAMED

Identifiers

Primary DI / UDI-DI: 06975445472092 EUDAMED
Basic UDI-DI: B-06975445472092 EUDAMED
EMDN Code: W0105099099 VIROLOGY - RT & POC - OTHER EUDAMED

Classification

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

Clinical & Handling

Sterile

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Microbial Substances

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

EUDAMED

Near-Patient Testing

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

EUDAMED

Surgical Instrument

EUDAMED

Syphilis Rapid Test Kit (Colloidal Gold Method) by Farmasino Medical 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-06975445472092	Class IVD General	Active

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Manufacturer

Manufacturer: Farmasino Medical Co., Ltd
EUDAMED SRN: CN-MF-000026190
Authorised Representative: Humiss International B.V. NL-AR-000001490

Sources (1)

EUDAMED 20748203-1304-4cdc-9adf-2195cc322baf 61 fields · synced Jun 18, 2026