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DR-U PRP Kit 1

by Kaizen Endustri Sanayi Ve Diş Tic.ltd.şti. Türkiye EUDAMED

Ref OM-DR1-0001

EMDN B030201

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08683324490058 Basic UDI-DIDate27 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/MDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
OM-DR1-0001
Primary DI / UDI-DI
08683324490058
Basic UDI-DI
B-08683324490058
EMDN Code
B030201 Plasmapheresis devices and kits
Device Class
Class IIb
Market of Registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000024428

Other devices from Kaizen Endustri Sanayi Ve Diş Tic.ltd.şti.

See all devices from Kaizen Endustri Sanayi Ve Diş Tic.ltd.şti. →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
Other properties (11)
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED a5770d6f-b724-4175-873e-04c2c5744ffd 61 fields · synced 22 Oct 2026