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U-Flex Ureteral Access Sheath

by Allwin Medical Devices, Inc United States EUDAMED

Ref UF11.5/9.5-45 EMDN U0399

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number081226101UAS012SH Basic UDI-DIDate10 Jun 2026RegisteredStatusActive

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  • Withdrawn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 25 Oct 2026

Model / Reference
UF11.5/9.5-45
Primary DI / UDI-DI
00812261019758
Basic UDI-DI
081226101UAS012SH
EMDN Code
U0399 Devices for urinary tract dilation - other
Device Class
Class I
Market of Registration
Greece

Manufacturer details

EUDAMED SRN
US-MF-000011349
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from Allwin Medical Devices, Inc.

See all devices from Allwin Medical Devices, Inc. →

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 00812261019758|081226101UAS012SH 61 fields · synced 25 Oct 2026