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Non-sterile Reusable Lithotripsy System

by G-Flex Flexible Instruments Europe Belgium EUDAMED

Ref 22660 EMDN G0305010201

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number54200513-TF07-BKT-RU-EA Basic UDI-DIDate13 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • BE25/00000030 Supplemented

    Quality management system EU MDR

    Notified body
    Notified body 1639
    Issued
    21 Aug 2026
    Expires
    29 Jan 2030
    Reason
    Add device or group

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
22660
Primary DI / UDI-DI
05420051300211
Basic UDI-DI
54200513-TF07-BKT-RU-EA
EMDN Code
G0305010201 Digestive endoscopy, retrieval basket devices, revolving
Device Class
Class I
Market of Registration
Belgium

Manufacturer details

EUDAMED SRN
BE-MF-000000623

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Properties & raw data

Show properties, registry sources and raw records
  • Reusable
  • Reprocessed
Other properties (11)
  • Sterile: No
  • Implantable: 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 05420051300211|54200513-TF07-BKT-RU-EA 61 fields · synced 24 Oct 2026