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SampleFacts InstaSep 50

by SampleFacts AB Sweden EUDAMED

Ref 196-316-50

EMDN W0501010299

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number735017860InstaSepNC Basic UDI-DIDate18 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
InstaSep
Model / Reference
196-316-50
Primary DI / UDI-DI
07350178600032
Basic UDI-DI
735017860InstaSepNC
Direct Marketing DI
07350178600032
EMDN Code
W0501010299 Capillary blood collection devices - other
Device Class
Class A
Market of Registration
Sweden

Manufacturer details

EUDAMED SRN
SE-MF-000048513

Other devices from SampleFacts AB

Properties & raw data

Show properties, registry sources and raw records
Other properties (11)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED 72762167-7a27-4caa-92c5-e3c3eeb16196 61 fields · synced 22 Oct 2026