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NewBio Syphilis EIA TA - 96 Test Kit

by Newmarket Biomedical Ltd United Kingdom EUDAMED

Ref NB010Model NewBio Syphilis EIA TA

EMDN W0105010302

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-05060515140108 Basic UDI-DIDate30 Apr 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/IVDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Model / Reference
NewBio Syphilis EIA TA, NB010
Primary DI / UDI-DI
05060515140108
Basic UDI-DI
B-05060515140108
EMDN Code
W0105010302 Syphilis antibody assays total
Device Class
Class IVD General
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
  • Human Tissues
  • Animal Tissues
  • Microbial Substances
  • Reagent
  • Professional Testing
Other properties (5)
  • Sterile: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED a76e2bda-fd95-435e-b4f1-b93e78c9fadd 61 fields · synced 23 Oct 2026