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Glutack

by Gem SRL Italy EUDAMED

Ref GB-DS 30Model GB-DS 30; GB-DS 60; GB-DS SH 30; GB-DS SH 30; GB-DS SH 60

EMDN K0180

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberB-GB-DS30LZ Basic UDI-DIDate10 Oct 2022RegisteredStatusActive
European UnionCE/MDD NumberB-GB-DS30LZ Basic UDI-DIDate10 Oct 2022RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR, CE/MDD Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
GB-DS 30, GB-DS 60, GB-DS SH 30, GB-DS SH 60
Primary DI / UDI-DI
D-GB-DS30LZ, 08031902000647
Basic UDI-DI
B-GB-DS30LZ, 80319026A9
EMDN Code
K0180 Endotherapy devices - other accessories
Device Class
Class IIa
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000012892

Other devices from Gem SRL

See all devices from Gem SRL →

Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (2)

  • EUDAMED 658ca6b3-4a20-4e46-80f3-f605a23598ec 61 fields · synced 22 Oct 2026
  • EUDAMED 08031902000647|80319026A9 61 fields · synced 19 May 2026