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Orion

by WellMed BV EUDAMED

Active European Union

Ref R50AP, T50AP, M50HRP, T1000HRP, M100HRP, C-T50AP, M1000AP, M50AP, O500AP, M500HRP, C-T1000HRP, T050AP, O50AP, T500HRP, T100HRP, O100HRP, T100AP, C-T100HRP, R500AP, C-T1000AP, O1000AP, C-T500HRP, R500HRP

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number872081305R50AP6C Basic UDI-DIDate13 Jun 2022RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
Detection Systems
Model / Reference
R50AP, T50AP, M50HRP, T1000HRP, M100HRP, C-T50AP, M1000AP, M50AP, O500AP, M500HRP, C-T1000HRP, T050AP, O50AP, T500HRP, T100HRP, O100HRP, T100AP, C-T100HRP, R500AP, C-T1000AP, O1000AP, C-T500HRP, R500HRP
Primary DI / UDI-DI
08720813051359, 08720813051076, 08720813051236, 08720813051021, 08720813051243, 08720813051113, 08720813051304, 08720813051274, 08720813051212, 08720813051250, 08720813051069, 08720813051090, 08720813051199, 08720813051014, 08720813051007, 08720813051168, 08720813051083, 08720813051045, 08720813051373, 08720813051144, 08720813051229, 08720813051052, 08720813051335
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
NL-MF-000023115

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