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Predicine Blood Collection Kit

by Predicine, Inc. United States EUDAMED

Ref PD-SCK30B-007 EMDN W050101010201

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number08600139976PDSCK30B007RX Basic UDI-DIDate20 May 2026RegisteredStatusActive

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  • Withdrawn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 25 Oct 2026

Model / Reference
PD-SCK30B-007
Primary DI / UDI-DI
00860013997601
Basic UDI-DI
08600139976PDSCK30B007RX
Direct Marketing DI
00860013997601
EMDN Code
W050101010201 Blood collection, tubes with additives or serum separator
Device Class
Class A
Market of Registration
Greece

Manufacturer details

EUDAMED SRN
US-MF-000031888
Authorised representative
MDSS GmbH DE-AR-000005430

Other devices from Predicine, Inc.

Properties & raw data

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

Sources (1)

  • EUDAMED 3bf24995-dcd7-47cc-8909-58c95b6729e9 61 fields · synced 25 Oct 2026