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Atlas TPHA Kit, 100 Tests

by Atlas Medical GmbH Germany EUDAMED

Ref 8.00.19.0.0100 EMDN W0105010399

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-04260658550722 Basic UDI-DIDate30 Jun 2023RegisteredStatusActive

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  • Withdrawn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 22 Oct 2026

Model / Reference
8.00.19.0.0100
Primary DI / UDI-DI
04260658550722
Basic UDI-DI
B-04260658550722
EMDN Code
W0105010399 Syphilis reagents other
Device Class
Class IVD General
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000029961

Other devices from Atlas Medical GmbH

See all devices from Atlas Medical GmbH →

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 5c6f58c0-6bdb-43c4-922f-a2b1214686b1 61 fields · synced 22 Oct 2026