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Kyrey Pharma - Apositos Medianos

by Eurosirel Spa

Ref CAE514028

Active European Union

CE MDR

Valid until

6 Aug 2030

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

2 certificates

Certifier ISTITUTO SUPERIORE DI SANITA'

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 Number8017990CAYFR Basic UDI-DI 08414807514028UDI-DIDate21 Jul 2026RegisteredStatusActive

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • CSQ0031250126 Active Supplemented

    Quality management system EU MDR

    Certifier
    ISTITUTO SUPERIORE DI SANITA' 0373
    Issued
    20 Mar 2026
    Expires
    6 Aug 2030
    Reason
    Add device or group
  • CVD005826 Active

    Technical documentation EU MDR

    Certifier
    ISTITUTO SUPERIORE DI SANITA' 0373
    Issued
    20 Mar 2026
    Expires
    6 Aug 2030

Coverage

1 jurisdiction

NorwayIcelandSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaLiechtensteinAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyTürkiyeCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Map note: Northern Ireland has no dot of its own.

  • Austria
  • Belgium
  • Bulgaria
  • Croatia
  • Cyprus
  • Czechia
  • Denmark
  • Estonia
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • Iceland
  • Ireland
  • Italy
  • Latvia
  • Liechtenstein
  • Lithuania
  • Luxembourg
  • Malta
  • Netherlands
  • Northern Ireland
  • Norway
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • Sweden
  • Türkiye

Specification

EUDAMED

Device Name
Plaster with antiseptic gauze
Model / Reference
CAE514028
Primary DI / UDI-DI
08414807514028
Basic UDI-DI
8017990CAYFR
EMDN Code
M040412 Antiseptics-based dressings
Device Class
Class III
EU market of registration
Spain

Manufacturer details

EUDAMED SRN
IT-MF-000005982

Other devices from Eurosirel Spa

See all devices from Eurosirel Spa →

Properties

  • Incorporates Medicinal Product

Other properties (12)

  • Sterile: No
  • 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