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Capitainer SEP10

by Capitainer AB Sweden EUDAMED

Ref 110-0050Model CapTwo

EMDN W0501010299

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number735013864CapTwoVL Basic UDI-DIDate19 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
CapTwo, 110-0050
Primary DI / UDI-DI
07350138640894
Basic UDI-DI
735013864CapTwoVL
Direct Marketing DI
07350138640894
EMDN Code
W0501010299 Capillary blood collection devices - other
Device Class
Class A
Market of Registration
Sweden

Manufacturer details

EUDAMED SRN
SE-MF-000023533

From the manufacturer

Manufacturer's product page: Capitainer®SEP10

Other devices from Capitainer AB

See all devices from Capitainer AB →

Properties & raw data

Show properties, registry sources and raw records
  • Self Testing
  • Professional Testing
Other properties (9)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED 07350138640894|735013864CAPTWOVL 61 fields · synced 24 Oct 2026