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Folioxane Restricted

by bess pro gmbh Germany EUDAMED

Ref FRRD100L

EMDN M04040701

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number1000301888 Date2 Jul 2026IssuedStatusActive expires 27 Feb 2030

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 1000301888 Supplemented

    Quality management system EU MDR

    Notified body
    Notified body 0297
    Issued
    2 Jul 2026
    Expires
    27 Feb 2030
    Reason
    Change approved

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Folioxane Restricted
Model / Reference
FRRD100L
Primary DI / UDI-DI
14063106101876
Basic UDI-DI
4063108FOLIOXREY8
EMDN Code
M04040701 Silicone dressings, non-combined
Device Class
Class IIa
Market of Registration
France

Manufacturer details

EUDAMED SRN
DE-MF-000006209

Other devices from bess pro gmbh

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Properties & raw data

Show properties, registry sources and raw records
  • Sterile
Other properties (12)
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED e8e11cb1-a9c7-4246-b8d2-efc58b355e43 61 fields · synced 24 Oct 2026