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Gynix

by Schultz Medical (UK) Ltd United Kingdom EUDAMED

Ref SM-GVS-B x30

EMDN Z12020799

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-65060697808010 Basic UDI-DIDate19 Feb 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/MDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
SM-GVS-B x30: Sterile, Single Use, Gynix® Hysteroscopic Sheath, 29Cm, Outer Diameter 3.5mm, Inner Diameter 1.8mm
Model / Reference
SM-GVS-B x30
Primary DI / UDI-DI
65060697808010
Basic UDI-DI
B-65060697808010
EMDN Code
Z12020799 Genitourinary endoscopy instruments – other
Device Class
Class I
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
UK-MF-000038582
Authorised representative
MDSS GmbH DE-AR-000005430

Other devices from Schultz Medical (UK) Ltd

See all devices from Schultz Medical (UK) Ltd →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
Other properties (10)
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 86b3eda7-f443-4577-a47a-adeb86ba40c2 61 fields · synced 22 Oct 2026