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Optitrol HEPA-2

by DiaMex GmbH Germany EUDAMED

Ref SR12037 EMDN W0105080807

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number426046567SRHEPAHH Basic UDI-DIDate19 May 2025RegisteredStatusWithdrawn

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Withdrawn

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Device Name
Optitrol HEPA-1
Model / Reference
SR12037
Primary DI / UDI-DI
4260465670491
Basic UDI-DI
426046567SRHEPAHH
Direct Marketing DI
4260465670491
EMDN Code
W0105080807 Multiconstituent controls - inf.imm.
Device Class
Class B
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000037219

Properties & raw data

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

Sources (1)

  • EUDAMED b609151e-1b6d-4a15-bb49-cb8bcc642ac6 61 fields · synced 23 Oct 2026