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Septoquat AM MD/RFU

by Живас Оод Bulgaria EUDAMED

Ref zh016/1/en/01

EMDN D0902

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number38002282401654 Basic UDI-DIDate10 Oct 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 2025-MDR/QS-047 Issued

    Quality management system EU MDR

    Notified body
    3EC International a.s. 2265
    Issued
    24 Sep 2025
    Expires
    10 Nov 2028

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Septoquat AM MD/RFU
Model / Reference
zh016/1/en/01
Primary DI / UDI-DI
03800228240427
Basic UDI-DI
38002282401654
EMDN Code
D0902 Associated ammonium salts for the disinfection of medical devices
Device Class
Class IIb
Market of Registration
Bulgaria

Manufacturer details

EUDAMED SRN
BG-MF-000019745

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Properties & raw data

Show properties, registry sources and raw records
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

Sources (1)

  • EUDAMED 601dc64b-138a-4f70-b408-fb39d6704ff2 61 fields · synced 22 Oct 2026