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Low-Profile Gastrostomy Replacement Tube (G. Button) Kit

by Sky Medical a.s. EUDAMED

Active European Union

Ref GH163510BI

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number602147GBUTTON5G Basic UDI-DIDate28 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  • Withdrawn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

Model / Reference
GH163510BI
Primary DI / UDI-DI
18586026081227
Basic UDI-DI
602147GBUTTON5G
EMDN Code
G02020201 Gastrostomy, tubes and sets
Device Class
Class IIb
Market of Registration
Slovakia

Manufacturer details

EUDAMED SRN
SK-MF-000001475

Related devices

Category: Gastrostomy tube

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Properties

Show properties
  • Sterile
  • Administering Medicine
Other properties (11)
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No