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RM EvoGyn COLLECTION PREP

by RM Life Science Co., Ltd. South Korea EUDAMED

Ref B002-0804Model B002-0801, B002-0802, B002-0804

EMDN W05019099

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number880031266B0QR Basic UDI-DIDate15 Jul 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Device Name
HPV Collection Kit
Model / Reference
B002-0801, B002-0802, B002-0804
Primary DI / UDI-DI
08800312660402
Basic UDI-DI
880031266B0QR
EMDN Code
W05019099 Samples collection devices - other
Device Class
Class A
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
KR-MF-000048522
Authorised representative
Javitech Consulting GmbH DE-AR-000045915

Other devices from RM Life Science Co., Ltd.

See all devices from RM Life Science Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Reagent
  • Professional Testing
Other properties (8)
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED 08800312660402|880031266B0QR 61 fields · synced 25 Oct 2026