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Single-Use Digital Flexible Ureteroscopes

by Ningbo Xinwell Medical Technology Co., Ltd 19 variants

Ref XY-L630-A-1Model XY-S600-A，XY-S600-B，XY-L600-A，XY-L600-B，XY-S630-A，XY-S630-B，XY-L630-A，XY-L630-B，XY-S650-A，XY-S650-B，XY-L650-A，XY-L650-B

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 Number697452906YSLXC Basic UDI-DI 06974529069920UDI-DIDate25 Jun 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  • Withdrawn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-S600-A，XY-S600-B，XY-L600-A，XY-L600-B，XY-S630-A，XY-S630-B，XY-L630-A，XY-L630-B，XY-S650-A，XY-S650-B，XY-L650-A，XY-L650-B, XY-L630-A-1
Primary DI / UDI-DI
06974529069920
Basic UDI-DI
697452906YSLXC
EMDN Code
Z12020713 Ureterorenoscopes
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.

See all devices from Ningbo Xinwell Medical Technology 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