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Syphilis Ab Rapid Test Cassette (Whole Blood/Serum/Plasma)

by Healgen Scientific Limited Liability Company

Ref GCSYP-402a, VT-SYP-25Model Syphilis (Whole blood /Serum /Plasma) Rapid Test Cassette Test rapid Sifilis (sange total/ser/plasma) caseta

Active European Union

CE IVDR CE IVDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR NumberB-GCSYP-402aHGN7 Basic UDI-DI Date31 Mar 2026RegisteredStatusActive
European UnionCE/IVDD NumberB-GCSYP-402aHGN7 Basic UDI-DI Date31 Mar 2026RegisteredStatusActive

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.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDR, CE/IVDD Active

Specification

EUDAMED

Trade Name
Syphilis Ab Rapid Test Cassette (Whole Blood/Serum/Plasma)
Syphilis (Whole blood /Serum /Plasma) Rapid Test Cassette Test rapid Sifilis (sange total/ser/plasma) caseta
Model / Reference
GCSYP-402a, Syphilis (Whole blood /Serum /Plasma) Rapid Test Cassette Test rapid Sifilis (sange total/ser/plasma) caseta, VT-SYP-25
Primary DI / UDI-DI
D-GCSYP-402aHGN7, 05944759080058
Basic UDI-DI
B-GCSYP-402aHGN7, 5944759080VTSYP25WBSPC3BE
Direct Marketing DI
05944759080058
EMDN Code
W0105090105 Syphilis - rt & poc
Device Class
Class IVD General
Class C
EU market of registration
Germany
Romania

Manufacturer details

EUDAMED SRN
US-MF-000018839
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from Healgen Scientific Limited Liability Company

See all devices from Healgen Scientific Limited Liability Company →

Properties

  • Animal Tissues YesEUDAMEDNoEUDAMED
  • Microbial Substances NoEUDAMEDYesEUDAMED
  • Professional Testing
  • New Device

Other properties (7)

  • Sterile: No
  • Human Tissues: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No