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Scorpius

by WellMed BV Netherlands EUDAMED

Ref KitO100HRP, KitO500HRP, KitT1000HRP, KitT500HRP, KitO50HRP, KitT100HRP EMDN W01029003

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number872081305KitO100HRPTG 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  • Withdrawn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 · synced 22 Oct 2026

Device Name
Detection Systems
Model / Reference
KitO100HRP, KitO500HRP, KitT1000HRP, KitT500HRP, KitO50HRP, KitT100HRP
Primary DI / UDI-DI
08720813051441, 08720813051458, 08720813051427, 08720813051410, 08720813051434, 08720813051403
Basic UDI-DI
872081305KitO100HRPTG, 872081305KitO500HRPV4, 872081305KitT1000HRPML, 872081305KitT500HRPXR, 872081305KitO50HRPAJ, 872081305KitT100HRPW5
EMDN Code
W01029003 Buffers (unassignable), supplem. reagents, etc (ic)
Device Class
Class A
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
NL-MF-000023115

Other devices from WellMed BV

See all devices from WellMed BV →

Properties & raw data

Show properties, registry sources and raw records
  • Reagent
  • Professional Testing
  • New Device
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (6)

  • EUDAMED 888beece-7523-4602-987f-cc83d2a5c387 61 fields · synced 22 Oct 2026
  • EUDAMED 08720813051458|872081305KITO500HRPV4 61 fields · synced 16 May 2026
  • EUDAMED 08720813051427|872081305KITT1000HRPML 61 fields · synced 17 May 2026
  • EUDAMED 08720813051410|872081305KITT500HRPXR 61 fields · synced 17 May 2026
  • EUDAMED 08720813051434|872081305KITO50HRPAJ 61 fields · synced 18 May 2026
  • EUDAMED 08720813051403|872081305KITT100HRPW5 61 fields · synced 18 May 2026