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Detro Sept AF1 L

by Detro Healthcare Ki̇mya Sanayi̇ Anoni̇m Şi̇rketi̇

Ref S-M.DET.4.0004Model Detrosept AF 1 litre

Active European Union

CE MDR

Valid until

16 Jun 2031

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier SZUTEST Konformitätsbewertungsstelle GmbH

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 Number868009710TF03GM Basic UDI-DI 08680097100054UDI-DIDate18 Jun 2026RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 2975-MED-2616801 Active

    Quality management system EU MDR

    Certifier
    SZUTEST Konformitätsbewertungsstelle GmbH 2975
    Issued
    17 Jun 2026
    Expires
    16 Jun 2031

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference
Detrosept AF 1 litre, S-M.DET.4.0004
Primary DI / UDI-DI
08680097100054
Basic UDI-DI
868009710TF03GM
EMDN Code
D0702 Isopropyl alcohol for the disinfection of medical devices
Device Class
Class IIa
EU market of registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000022410

From the manufacturer

Manufacturer's product page: El Ve Cilt Antiseptikleri, Temizleyicileri ve Bakımı

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Properties

Other properties (13)

  • 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
  • Incorporates Medicinal Product: No