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Cutimed Epiona

by Medskin Solutions Dr. Suwelack AG 4 variants

Ref 83721-011 (73228-03)

Active European Union

CE MDR CE MDD

Valid until

5 Jul 2031

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier DNV MEDCERT GmbH

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number11833GB450260825 Date25 Aug 2026IssuedStatusActive expires 5 Jul 2031
European UnionCE/MDD NumberB-04250569302190 Basic UDI-DI 04250569302190UDI-DIDate16 Jun 2026RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 11833GB450260825 Active Supplemented

    Technical documentation EU MDR

    Certifier
    DNV MEDCERT GmbH 0482
    Issued
    25 Aug 2026
    Expires
    5 Jul 2031
    Reason
    Add device or group

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR, CE/MDD Active

Specification

EUDAMED

Device Name
Collagen Alginate
Model / Reference
83721-011 (73228-03)
Primary DI / UDI-DI
04250569302190
Basic UDI-DI
B-04250569302190, 425056904054
EMDN Code
M04041002 Animal-derived collagen dressings, combined with other substances
Device Class
Class III
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000007747

Other devices from MedSkin Solutions Dr. Suwelack AG

  • Cutimed Epiona

    Class III

  • MatriDerm

    Class III

  • ProHeal

    Class III

  • MatriDerm pluS+ Bi-Layer

    Unclassified

  • MatriDerm

    Class III

  • MatriDerm

    Class III

See all devices from MedSkin Solutions Dr. Suwelack AG →

Properties

  • Sterile
  • Animal Tissues

Other properties (11)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No