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Roman™

by Yeni̇ Bi̇yoteknoloji̇ Anoni̇m Şi̇rketi̇ Ege Serbest Bölgesi̇ Şubesi̇ Türkiye EUDAMED

Ref RMN06

EMDN W05020199

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number8682974700166EJ Basic UDI-DIDate28 Jan 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
RMN06
Primary DI / UDI-DI
08682974700166
Basic UDI-DI
8682974700166EJ
Direct Marketing DI
08682974700166
EMDN Code
W05020199 Samples transport, containers - other
Device Class
Class A
Market of Registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000046180

Other devices from Yeni̇ Bi̇yoteknoloji̇ Anoni̇m Şi̇rketi̇ Ege Serbest Bölgesi̇ Şubesi̇

Properties & raw data

Show properties, registry sources and raw records
  • Surgical Instrument
  • 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
  • Professional Testing: No
  • Companion Diagnostics: No

Sources (1)

  • EUDAMED f0e6e9b9-5ae6-4e9a-8684-8de601cc3683 61 fields · synced 22 Oct 2026