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Single Use Flexible Ureteroscope

by Miconvey Technologies Co., Ltd. 16 variants

Ref EPU-7640Model 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

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number0697471025EPU-MDR-CEX Basic UDI-DI 06974710259482UDI-DIDate24 Jul 2026RegisteredStatusActive

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  • Withdrawn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
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
06974710259482
Basic UDI-DI
0697471025EPU-MDR-CEX
Direct Marketing DI
06974710259482
EMDN Code
Z12020709 Uteroscopes
Device Class
Class IIa
EU 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

  • 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