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allFlex Ureteral Catheters

by Allwin Medical Devices, Inc United States EUDAMED

Ref UC-O7Model allFlex Ureteral Catheters (Closed Tip,Open Tip), allFlex Ureteral Catheters Cone Tip,allFlex Ureteral Catheters (Angle Closed Tip,Angle Open Tip),allFlex Ureteral Catheters Open Tapered Tip,Krait Ureteral Catheters (Closed Tip, Open Tip)

EMDN U0299

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number081226101UCT017TQ Basic UDI-DIDate5 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Device Name
Ureteral Catheters
Model / Reference
allFlex Ureteral Catheters (Closed Tip, Open Tip), allFlex Ureteral Catheters Cone Tip, allFlex Ureteral Catheters (Angle Closed Tip, Angle Open Tip), allFlex Ureteral Catheters Open Tapered Tip, Krait Ureteral Catheters (Closed Tip, UC-O7
Primary DI / UDI-DI
00812261013046
Basic UDI-DI
081226101UCT017TQ
EMDN Code
U0299 Ureteral catheters - other
Device Class
Class IIa
Market of Registration
Romania

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 fd487ce1-8585-4cec-83be-56176aa53119 61 fields · synced 23 Oct 2026