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Atlas TPHA Kit, 200 Tests

by Atlas Medical GmbH EUDAMED

Active European Union

Ref 8.00.19.0.0200

Overview

The Atlas TPHA Kit, a medical device used for testing and diagnosing diseases, is designed to provide accurate and reliable results. This kit features a proprietary algorithm that automates the process of analyzing samples, reducing errors and increasing precision.

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-04260658551224 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  • Withdrawn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

Model / Reference
8.00.19.0.0200
Primary DI / UDI-DI
04260658551224
Basic UDI-DI
B-04260658551224
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

  • 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