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Zhivasept OPA

by Живас Оод Bulgaria EUDAMED

Ref zh/052/4000/bg/01, zh052/5000/bg/01

EMDN D0199

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number38002282405258 Basic UDI-DIDate16 Jan 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 2023-MDR/QS-057 Issued

    Quality management system EU MDR

    Notified body
    3EC International a.s. 2265
    Issued
    1 Dec 2023
    Expires
    1 Dec 2028

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Zhivasept OPA
Model / Reference
zh/052/4000/bg/01, zh052/5000/bg/01
Primary DI / UDI-DI
03800228243664, 03800228243657
Basic UDI-DI
38002282405258
EMDN Code
D0199 Aldehydes for the disinfection of medical devices - other
Device Class
Class IIb
Market of Registration
Bulgaria

Manufacturer details

EUDAMED SRN
BG-MF-000019745

Other devices from Живас Оод

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    Class IIb

  • Glutasept S

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See all devices from Живас Оод →

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 (2)

  • EUDAMED 55a9837b-7afc-414a-9e9c-1976d6049fc5 61 fields · synced 22 Oct 2026
  • EUDAMED ad4acaff-841f-42f0-865e-ab0673c6bd53 61 fields · synced 17 May 2026