Skip to content

I-PREP Filter

by Imedikers Co., Ltd. South Korea EUDAMED

Ref I-PREP Filter

EMDN W05030580

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number0317990IPREPFILTERX7 Basic UDI-DIDate6 Sep 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Model / Reference
I-PREP Filter
Primary DI / UDI-DI
08800317990061
Basic UDI-DI
0317990IPREPFILTERX7
EMDN Code
W05030580 Devices for patology tests - accessories
Device Class
Class A
Market of Registration
Romania

Manufacturer details

EUDAMED SRN
KR-MF-000047937
Authorised representative
Veritas Eston OÜ EE-AR-000046695

Other devices from Imedikers Co., Ltd.

Properties & raw data

Show properties, registry sources and raw records
  • Professional Testing
Other properties (10)
  • 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
  • New Device: No

Sources (1)

  • EUDAMED b959e007-b7dd-4e73-8937-4de56dbda3b3 61 fields · synced 23 Oct 2026