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Atlas RPR Carbon Antigen Kit, 500 Tests (10 ml Reagent, 2x1 ml Controls)

by Atlas Medical GmbH

Ref 8.00.18.3.0500, 8.00.18.7.0500, 8.00.18.2.0500

Active European Union

CE IVDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-04260658550111 Basic UDI-DI Date22 Jul 2023RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDD Active

Specification

EUDAMED

Trade Name
Atlas RPR Carbon Antigen Kit, 500 Tests (10 ml Reagent, 2x1 ml Controls)
Atlas RPR Carbon Antigen Kit, 500 Tests (10 ml Reagent, 2x1 ml Controls, Stirring sticks, White Glass Slide).
Atlas RPR Carbon Antigen Kit, 500 Tests (10 ml Reagent, 2x1 ml Controls, Stirring sticks).
Model / Reference
8.00.18.3.0500, 8.00.18.7.0500, 8.00.18.2.0500
Primary DI / UDI-DI
04260658550111, 04260658550821, 04262408511311
Basic UDI-DI
B-04260658550111, B-04260658550821, B-04262408511311
EMDN Code
W0105010399 Syphilis reagents other
Device Class
Class IVD General
EU 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