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Single-use Ureteral Access Sheath

by Scivita Medical Technology Co., Ltd. 45 variants

Ref UB-1350Model UB-(1025,1035,1040,1045,1050,1055,1125,1135,1140,1145,1150,1155,1225,1235,1240,UB-1245,UB-1250,UB-1255,UB-1325,UB-1335,UB-1340,UB-1345,UB-1350,UB-1355,UB-1425,UB-1435,UB-1440,UB-1445,UB-1450,UB-1455)

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697138125045A8X Basic UDI-DI 06971381257519UDI-DIDate10 Oct 2025RegisteredStatusActive

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  • Withdrawn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
UB-(1025, 1035, 1040, 1045, 1050, 1055, 1125, 1135, 1140, 1145, 1150, 1155, 1225, 1235, 1240, UB-1245, UB-1250, UB-1255, UB-1325, UB-1335, UB-1340, UB-1345, UB-1350, UB-1355, UB-1425, UB-1435, UB-1440, UB-1445, UB-1450, UB-1455)
Primary DI / UDI-DI
06971381257519
Basic UDI-DI
697138125045A8X
Direct Marketing DI
06971381257519
EMDN Code
U0601 Urological guidewires, hydrophilic
Device Class
Class IIa
EU market of registration
Belgium

Manufacturer details

EUDAMED SRN
CN-MF-000010305
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Scivita Medical Technology Co., Ltd.

See all devices from Scivita 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