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Silicone Round Drain Kit

by Fortune Medical Instrument Corp. United States EUDAMED

Ref CO2015-9210

EMDN A0601010402

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-14711182605718 Basic UDI-DIDate15 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/MDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
CO2015-9210
Primary DI / UDI-DI
14711182605718, 04711182605711
Basic UDI-DI
B-14711182605718, B-04711182605711
EMDN Code
A0601010402 Cylindrical or circular drainages (straight and t-shaped)
Device Class
Class IIa
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
TW-MF-000009221
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Related devices

Category: Biliary drain

Other devices from Fortune Medical Instrument Corp.

See all devices from Fortune Medical Instrument Corp. →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
Other properties (10)
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (2)

  • EUDAMED 0f2209d3-aadf-4fc2-939b-cff880ace868 61 fields · synced 22 Oct 2026
  • EUDAMED 04711182605711|B-04711182605711 61 fields · synced 31 Jul 2026