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Oxiplex/IU Gel

by FzioMed, Inc.

Ref FPC-09017

Oxiplex/IU Gel (FPC-09017) is a Class IIb device made by FzioMed, Inc., registered in EUDAMED on 29 Oct 2026 (Basic UDI-DI B-10854395004214), active as of 7 Nov 2026.

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

Source EUDAMED, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-10854395004214 Basic UDI-DI 10854395004214UDI-DIDate29 Oct 2026RegisteredStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Active

Specification

EUDAMED

Model / reference
FPC-09017
Primary DI / UDI-DI
10854395004214
Basic UDI-DI
B-10854395004214
EMDN code
M0406 Dressings for the prevention of post-operative adhesions
Device class
Class IIb
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

Similar devices in this category

Other devices filed under DRESSINGS FOR THE PREVENTION OF POST-OPERATIVE ADHESIONS.

Other devices from FzioMed, Inc.

See all devices from FzioMed, Inc. →

Properties

  • Supplied sterile
  • Implantable
Other properties (10, all answered No)