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Gastrostomy Tube and Accessories

by Hangzhou Fushan Medical Appliances Co., Ltd. 241 variants

Ref GTK-1605E

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69536763GT001QW Basic UDI-DI 06953676315418UDI-DIDate25 Sep 2025RegisteredStatusActive

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  • Withdrawn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
GTK-1605E
Primary DI / UDI-DI
06953676315418
Basic UDI-DI
69536763GT001QW
EMDN Code
G02020201 Gastrostomy, tubes and sets
Device Class
Class IIb
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
CN-MF-000022768
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Related devices

Category: Gastrostomy tube

Other devices from Hangzhou Fushan Medical Appliances Co., Ltd.

See all devices from Hangzhou Fushan Medical Appliances Co., Ltd. →

Properties

  • 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