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Drainage Catheter & Sets

by Allwin Medical Devices, Inc United States EUDAMED

Ref PCN-P16-U

EMDN U040203

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number081226101DCS007LH Basic UDI-DIDate8 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

Model / Reference
PCN-P16-U
Primary DI / UDI-DI
00819374026888
Basic UDI-DI
081226101DCS007LH
EMDN Code
U040203 Nephrostomy catheters
Device Class
Class IIa
Market of Registration
Czechia

Manufacturer details

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

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 42e73be9-31f4-43dc-a008-87ac963019cb 61 fields · synced 23 Oct 2026