One Step Syphilis Anti-TP Test (Colloidal Gold)

by Beijing Hotgen Biotech Co., Ltd. EUDAMED

Active European Union

Ref HGCG06Model Please see the IFU

Regulatory status

as of 28 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/IVDR	Number697029753446LW Basic UDI-DI	Date18 Aug 2026Registered	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

European Union — CE/IVDR Active

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Specification

EUDAMED

Model / Reference: Please see the IFU, HGCG06

Primary DI / UDI-DI: 06936700408812
Basic UDI-DI: 697029753446LW
EMDN Code: W0105010302 Syphilis antibody assays total

Device Class: Class C
Market of Registration: Germany

Manufacturer details

EUDAMED SRN: CN-MF-000015566
Authorised representative: MedNet EC-REP GmbH DE-AR-000000002

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Properties

Animal Tissues
Reagent
Professional Testing

Other properties (8)

Sterile: No
Human Tissues: No
Microbial Substances: No
Self Testing: No
Near-Patient Testing: No
Companion Diagnostics: No
Surgical Instrument: No
New Device: No