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LiNA Versascope Sheath - Enclosed

by LiNA Medical AG EUDAMED

Active European Union

Ref GMS815Model GMS805; GMS815-E

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number57082651023-1ZH Basic UDI-DIDate17 Aug 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  • Withdrawn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

Device Name
LiNA Versascope Sheath; LiNA Versascope Sheath - Enclosed
Model / Reference
GMS805, GMS815-E, GMS815
Primary DI / UDI-DI
05708265018093
Basic UDI-DI
57082651023-1ZH
EMDN Code
Z12020799 Genitourinary endoscopy instruments – 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

Show properties
  • Sterile
Other properties (12)
  • 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