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Single-use Ureteral Access Sheath

by Scivita Medical Technology Co., Ltd. United States EUDAMED

Ref UB-1150Model 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) EMDN U0601

Regulatory status

as of 25 Oct 2026

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

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

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), UB-1150
Primary DI / UDI-DI
06971381257427
Basic UDI-DI
697138125045A8X
Direct Marketing DI
06971381257427
EMDN Code
U0601 Urological guidewires, hydrophilic
Device Class
Class IIa
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 & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED c7263e50-e167-4d98-9051-d8f14cd658e8 61 fields · synced 24 Oct 2026