Syphilis Ab Rapid Test Cassette (Whole Blood +2 more)

EUDAMED

Class IVD General (EU MDR)

Ref GCSYP-402a

by Zhejiang Orient Gene Biotech Co., Ltd

Identity

Trade Name: Syphilis Ab Rapid Test Cassette (Whole Blood/Serum/Plasma) EUDAMED
Device Name: Syphilis Ab Rapid Test Cassette (Whole Blood/Serum/Plasma) EUDAMED
Model / Reference: GCSYP-402a EUDAMED

Identifiers

Primary DI / UDI-DI: 06950996002363 EUDAMED
Basic UDI-DI: B-06950996002363 EUDAMED
EMDN Code: W0105090105 SYPHILIS - RT & POC EUDAMED
Models / Variants: Whole Blood EUDAMED
Serum EUDAMED
Plasma 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

EUDAMED

Self Testing

EUDAMED

Near-Patient Testing

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

EUDAMED

Surgical Instrument

EUDAMED

Syphilis Ab Rapid Test Cassette (Whole Blood +2 more) by Zhejiang Orient Gene Biotech Co., Ltd — Class IVD General — IVDD — listed in EUDAMED — 3 models

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-06950996002363	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 6571e647-1922-456a-8086-10baea0a538f 61 fields · synced Oct 6, 2026