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Treponema pallidum (Spirochete)

by Biocare Medical United States EUDAMED

Ref OPAI135T60 EMDN W0102039099

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-00847627031181 Basic UDI-DIDate25 Aug 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Model / Reference
OPAI135T60
Primary DI / UDI-DI
00847627031181
Basic UDI-DI
B-00847627031181
EMDN Code
W0102039099 Tumour markers - other
Device Class
Class IVD General
Market of Registration
Sweden

Manufacturer details

EUDAMED SRN
US-MF-000034581
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from Biocare Medical, LLC

See all devices from Biocare Medical, LLC →

Properties & raw data

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

Sources (1)

  • EUDAMED 00847627031181|B-00847627031181 61 fields · synced 25 Oct 2026