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Single-use Digital Flexible Cystoscopes

by Ningbo Xinwell Medical Technology Co., Ltd 8 variants

Ref XY-SC42S-1S-0Model XY-SC42S-0S, XY-SC42S-1S, XY-SC42S-0R, XY-SC42S-1R, XY-SC54S-0S, XY-SC54S-1S, XY-SC54S-0R, XY-SC54S-1R

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69420679SCFA Basic UDI-DI 06942067977878UDI-DIDate7 May 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  • Withdrawn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
XY-SC42S-0S, XY-SC42S-1S, XY-SC42S-0R, XY-SC42S-1R, XY-SC54S-0S, XY-SC54S-1S, XY-SC54S-0R, XY-SC54S-1R, XY-SC42S-1S-0
Primary DI / UDI-DI
06942067977878
Basic UDI-DI
69420679SCFA
EMDN Code
Z12020701 Cystoscopes
Device Class
Class IIa
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000001084
Authorised representative
Lotus NL B.V. NL-AR-000000121

Other devices from Ningbo Xinwell Medical Technology Co., Ltd.

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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