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Eustachian tube balloon dilation kits

by Guangdong Kangerle Medical Instruments Co., Ltd. EUDAMED

Active European Union

Ref KELYG2025GS, KELYG3020GS, KELYG3015GSModel KELYG3020GS, KELYG3015GS, KELYG2520GS, KELYG2515GS

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69318427ETBDKRM Basic UDI-DIDate13 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  • Withdrawn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

Device Name
Eustachian tube balloon dilation kits
Model / Reference
KELYG3020GS, KELYG3015GS, KELYG2520GS, KELYG2515GS, KELYG2025GS
Primary DI / UDI-DI
06931842702507, 06931842702538, 06931842702521
Basic UDI-DI
69318427ETBDKRM
EMDN Code
Q030308 ENT surgery dilators, single-use
Device Class
Class I
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000047760
Authorised representative
MedNet EC-REP GmbH DE-AR-000000002

Other devices from Guangdong Kangerle Medical Instruments 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