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Newbio TPHA 200

by Newmarket Biomedical Ltd United Kingdom EUDAMED

Ref NB008Model TPHA

EMDN W0105010302

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number506051514TPHA7L Basic UDI-DIDate30 Apr 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Device Name
Newbio TPHA
Model / Reference
TPHA, NB008
Primary DI / UDI-DI
05060515140276, 05060515140085
Basic UDI-DI
506051514TPHA7L
EMDN Code
W0105010302 Syphilis antibody assays total
Device Class
Class C
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
GB-MF-000025155
Authorised representative
MDSS GmbH DE-AR-000005430

Other devices from Newmarket Biomedical Ltd

See all devices from Newmarket Biomedical Ltd →

Properties & raw data

Show properties, registry sources and raw records
  • Animal Tissues
  • Microbial Substances
  • Reagent
  • Professional Testing
Other properties (7)
  • Sterile: No
  • Human Tissues: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (2)

  • EUDAMED 3b88ab92-db9e-4afb-bdb8-a88becde5f19 61 fields · synced 23 Oct 2026
  • EUDAMED 05060515140085|506051514TPHA7L 61 fields · synced 17 May 2026