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Kytogen Defend

by KiOmed Pharma SA

Ref KIO015

Active European Union

CE MDR

Valid until

1 Aug 2031

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

2 certificates

Certifier DEKRA Certification B.V.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number2290556CE01 Date4 Aug 2026IssuedStatusActive expires 1 Aug 2031

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • 2290556CE01 Active

    Quality management system EU MDR

    Certifier
    DEKRA Certification B.V. 0344
    Issued
    4 Aug 2026
    Expires
    1 Aug 2031
  • 2290556TD01 Active

    Technical documentation EU MDR

    Certifier
    DEKRA Certification B.V. 0344
    Issued
    4 Aug 2026
    Expires
    1 Aug 2031

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
KIO015
Model / Reference
KIO015
Primary DI / UDI-DI
05404023515063
Basic UDI-DI
54040235KIO_015BL
EMDN Code
X0303 Substances, combinations of substances, or items without an intended medical purpose intended to be used for facial or other dermal or mucous membrane filling by subcutaneous, submucous or intradermal injection or other introduction, by a prefilled means for introduction, excluding those for tattooing – resorbable
Device Class
Class III
EU market of registration
Spain

Manufacturer details

EUDAMED SRN
BE-MF-000012034

Properties

  • Sterile
  • Implantable

Other properties (11)

  • 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