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Single Use Flexible Ureteroscope

by Miconvey Technologies Co., Ltd. China EUDAMED

Ref EPU-7635Model EPU-7635, EPU-7640, EPU-7645, EPU-7650, EPU-7655, EPU-7660, EPU-7665, EPU-7670, EPU-7635R, EPU-7640R, EPU-7645R, EPU-7650R, EPU-7655R, EPU-7660R, EPU-7665R, EPU-7670R

EMDN Z12020709

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number0697471025EPU-MDR-CEX Basic UDI-DIDate24 Jul 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
EPU-7635, EPU-7640, EPU-7645, EPU-7650, EPU-7655, EPU-7660, EPU-7665, EPU-7670, EPU-7635R, EPU-7640R, EPU-7645R, EPU-7650R, EPU-7655R, EPU-7660R, EPU-7665R, EPU-7670R
Primary DI / UDI-DI
06974710259475
Basic UDI-DI
0697471025EPU-MDR-CEX
Direct Marketing DI
06974710259475
EMDN Code
Z12020709 Uteroscopes
Device Class
Class IIa
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
CN-MF-000031532
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Miconvey Technologies Co., Ltd.

See all devices from Miconvey Technologies Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED 06974710259475|0697471025EPU-MDR-CEX 61 fields · synced 24 Oct 2026