Skip to content

Predicine Bone Marrow Aspirate (BMA) Collection Kit™

by Predicine, Inc. EUDAMED

Active European Union

Ref PD-SCK30BM-026, PD-SCK30BM-027Model PD-SCK30BM-026

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number08600139976PDSCK30BM026UC Basic UDI-DIDate10 Mar 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  • Withdrawn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

Model / Reference
PD-SCK30BM-026, PD-SCK30BM-027
Primary DI / UDI-DI
00860013997663
Basic UDI-DI
08600139976PDSCK30BM026UC
EMDN Code
W050101010201 Blood collection, tubes with additives or serum separator
Device Class
Class A
Market of Registration
Germany

Manufacturer details

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

Other devices from Predicine, Inc.

Properties

  • New Device

Other properties (10)

  • 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