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SWISS optio basic regflow

by Gloor AG EUDAMED

Active European Union

Ref GX10058Model SWISS optio basic, varius, basic regflow

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number76308289000001TE Basic UDI-DIDate12 May 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  • Withdrawn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
Pressure regulator
Model / Reference
SWISS optio basic, varius, basic regflow, GX10058
Primary DI / UDI-DI
07630828920841
Basic UDI-DI
76308289000001TE
Direct Marketing DI
07630828920841
EMDN Code
Z120309 Medical/medicinal gas pipeline systems and related accessories
Device Class
Class IIb
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CH-MF-000014214
Authorised representative
Gloor Medical GmbH DE-AR-000012493

Other devices from Gloor AG

See all devices from Gloor AG →

Properties

  • CMR Substance
  • Administering Medicine

Other properties (11)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No