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Kerecis Omega3 Wound

by Kerecis Limited 3 variants

Ref 50200S14B0B, 50200S03B0B, 50200S16B0B, 50200S04B0B

Active European Union

CE MDD

Valid until

Not listed

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-50200SPA Basic UDI-DI Date28 Mar 2022RegisteredStatusActive

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  • Withdrawn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

Device Name
Kerecis™ Omega3 Wound
Model / Reference
50200S14B0B, 50200S03B0B, 50200S16B0B, 50200S04B0B
Primary DI / UDI-DI
D-50200SPA, D-50200S03AP, D-50200S16AY, D-50200S04AR
Basic UDI-DI
B-50200SPA, B-50200S03AP, B-50200S16AY, B-50200S04AR
EMDN Code
M04041001 Animal-derived collagen dressings, non-combined
Device Class
Class III
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
IS-MF-000001365

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  • MariCell

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Properties

  • Sterile
  • Animal Tissues YesEUDAMEDNoEUDAMED

Other properties (9)

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