Skip to content

Prospect® Ureteral Dilatation Balloon Catheter

by Princeton Medical Scientific Co., Ltd 24 variants

Ref 090901000851-1Model 090400400851-1

Active European Union

CE MDR

Valid until

16 Jan 2031

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier SGS Belgium NV

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberCN26/00000404 Date16 Jan 2026IssuedStatusActive expires 16 Jan 2031

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • CN26/00000404 Active

    Quality management system EU MDR

    Certifier
    SGS Belgium NV 1639
    Issued
    16 Jan 2026
    Expires
    16 Jan 2031

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Sterile Single Use Ureteral Dilatation Balloon Catheter
Model / Reference
090400400851-1, 090901000851-1
Primary DI / UDI-DI
06935456209001
Basic UDI-DI
69354562PLYL09XT
Direct Marketing DI
06935456209001
EMDN Code
U030202 Ureteral dilators, with balloon
Device Class
Class I
EU market of registration
Türkiye

Manufacturer details

EUDAMED SRN
CN-MF-000018402
Authorised representative
Wellkang Ltd XI-AR-000001836

Other devices from Princeton Medical Scientific Co., Ltd

See all devices from Princeton Medical Scientific 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