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Silicone Flat Drain

by Fortune Medical Instrument Corp. United States EUDAMED

Ref PR2014-0072

EMDN A0601010403

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-04711182604981 Basic UDI-DIDate17 Apr 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 23 Oct 2026

Model / Reference
PR2014-0072
Primary DI / UDI-DI
04711182604981, 14711182604988
Basic UDI-DI
B-04711182604981, B-14711182604988
EMDN Code
A0601010403 Flat and lamellar drainages
Device Class
Class IIa
Market of Registration
Italy
Spain

Manufacturer details

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

Related devices

Category: Closed-wound drain, non-bioabsorbable

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 6d561422-b85f-4b35-abc7-9056d2ae23f3 61 fields · synced 23 Oct 2026
  • EUDAMED 14711182604988|B-14711182604988 61 fields · synced 17 Oct 2026