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ONIRY Spectrometer

by OASIS Diagnostics S.A. Poland EUDAMED

Ref 001

EMDN U0899

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number59055678447001ZH Basic UDI-DIDate24 Apr 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
001
Primary DI / UDI-DI
05905567844713
Basic UDI-DI
59055678447001ZH
Direct Marketing DI
05905567844713
EMDN Code
U0899 Gynaecological devices - other
Device Class
Class IIa
Market of Registration
Poland

Manufacturer details

EUDAMED SRN
PL-MF-000018772

Other devices from OASIS Diagnostics S.A.

Properties & raw data

Show properties, registry sources and raw records
  • Measuring Function
Other properties (12)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 88a22163-c9bf-4b5d-a42b-405a7a8ce3ae 61 fields · synced 22 Oct 2026