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Silicone Round Drain

by Fortune Medical Instrument Corp. United States EUDAMED

Ref 2015-0216 EMDN A0601010402

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-04710961935582 Basic UDI-DIDate24 Jul 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Model / Reference
2015-0216
Primary DI / UDI-DI
04710961935582
Basic UDI-DI
B-04710961935582
EMDN Code
A0601010402 Cylindrical or circular drainages (straight and t-shaped)
Device Class
Class IIa
Market of Registration
Spain

Manufacturer details

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

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 (1)

  • EUDAMED 04710961935582|B-04710961935582 61 fields · synced 25 Oct 2026