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P0077 SeraQ TPHA Syphilis

by Biologicals Quality Control B.V. EUDAMED

Active European Union

Ref P0077/01

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number871871983P0077EW Basic UDI-DIDate8 Sep 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • 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
P0077/01
Primary DI / UDI-DI
08718719832899
Basic UDI-DI
871871983P0077EW
EMDN Code
W0105080801 Bacteriology controls - inf.imm.
Device Class
Class B
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
NL-MF-000026798

Other devices from Biologicals Quality Control B.V.

See all devices from Biologicals Quality Control B.V. →

Properties

  • Human Tissues
  • Animal Tissues
  • Microbial Substances
  • Professional Testing

Other properties (7)

  • Sterile: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No