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Silicone Flat Drain

by Fortune Medical Instrument Corp. 3 variants

Ref 2014-0072

Active European Union. Also listed in GUDID (US).

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-04710961934981 Basic UDI-DI Date17 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04710961934981 UDI-DI Date31 Jan 2022ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic Name
Closed-wound drain, non-bioabsorbable
Model / Reference
2014-0072
Primary DI / UDI-DI
04710961934981, 14710961934988
Basic UDI-DI
B-04710961934981, B-14710961934988
FDA Product Code
GCD
EMDN Code
A0601010403 Flat and lamellar drainages
GMDN Term
Closed-wound drain, non-bioabsorbable
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
878.4200
EU market of registration
Hungary
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class I

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

  • Sterile
  • Single Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (16)

  • 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
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No