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

by Sky Medical a.s. 856 variants

Ref GH120820BI

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number602147GBUTTON5G Basic UDI-DI 18586026081708UDI-DIDate28 Jan 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference
GH120820BI
Primary DI / UDI-DI
18586026081708
Basic UDI-DI
602147GBUTTON5G
EMDN Code
G02020201 Gastrostomy, tubes and sets
Device Class
Class IIb
EU market of registration
Slovakia

Manufacturer details

EUDAMED SRN
SK-MF-000001475

Related devices

Category: Gastrostomy tube

Other devices from Sky Medical a.s.

See all devices from Sky Medical a.s. →

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