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Dilation Balloon Catheter

by G-Flex Flexible Instruments Europe Belgium EUDAMED

Ref EZM1255

EMDN G03010199

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number54200513-TF03-DBC-SU-35 Basic UDI-DIDate8 Sep 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
EZM1255
Primary DI / UDI-DI
05420051301683
Basic UDI-DI
54200513-TF03-DBC-SU-35
EMDN Code
G03010199 Gastrointestinal endoscopy, balloon catheters - other
Device Class
Class I
Market of Registration
Belgium

Manufacturer details

EUDAMED SRN
BE-MF-000000623

From the manufacturer

Manufacturer's product page: Progressive Dilation Balloons

Other devices from G-Flex Flexible Instruments Europe

See all devices from G-Flex Flexible Instruments Europe →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Reprocessed
Other properties (11)
  • Implantable: No
  • Reusable: No
  • Contains Latex: 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 (1)

  • EUDAMED 05420051301683|54200513-TF03-DBC-SU-35 61 fields · synced 24 Oct 2026