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Oxiplex

by FzioMed, Inc.

Ref FPC-09006

Active European Union

CE MDD

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 7 Nov 2026. What this means

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-10854395004009 Basic UDI-DI 10854395004009UDI-DIDate29 Oct 2026RegisteredStatusActive

Official records

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

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDD Active

Specification

EUDAMED

Model / reference
FPC-09006
Primary DI / UDI-DI
10854395004009
Basic UDI-DI
B-10854395004009
EMDN code
M0406 Dressings for the prevention of post-operative adhesions
Device class
Class III
EU registration type
Legacy device (under a directive)
EU market of registration
Belgium

Manufacturer details

EUDAMED SRN
US-MF-000003603
Authorised representative
Obelis s.a. BE-AR-000000106

Other devices from FzioMed, Inc.

See all devices from FzioMed, Inc. →

Properties

  • Supplied sterile
  • Implantable

Other properties (10)

  • Sterilise before use: No
  • Reusable: No
  • Contains latex: No
  • Reprocessed single-use device: No
  • Incorporates a substance derived from human blood or plasma: No
  • Contains human tissues or cells: No
  • Contains animal tissues or cells: No
  • Administering medicine: No
  • Measuring function: No
  • Incorporates a medicinal substance: No