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LiNA OperaScope Recording Module

by LiNA Medical AG Switzerland EUDAMED

Ref OP-RM-1-EU EMDN Z12020499

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number57082651021-1RMEULT Basic UDI-DIDate30 Jan 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
OP-RM-1-EU
Primary DI / UDI-DI
05708265018154
Basic UDI-DI
57082651021-1RMEULT
EMDN Code
Z12020499 Instruments for the acquisition and management of endoscopic and minimally invasive surgery images – other
Device Class
Class I
Market of Registration
Denmark

Manufacturer details

EUDAMED SRN
CH-MF-000046832
Authorised representative
LiNA Medical Polska Sp. z o.o. PL-AR-000039364

Other devices from LiNA Medical AG

See all devices from LiNA Medical AG →

Properties & raw data

Show properties, registry sources and raw records
Other properties (13)
  • 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
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 08026483-a365-4c3d-98c0-83a168059ac2 61 fields · synced 24 Oct 2026