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HRF3000 Ozone

by B Science Bi̇yomedi̇kal Sanayi̇ Ve Ti̇caret Li̇mi̇ted Şi̇rketi̇ 3 variants

Ref 3S125Model 3S30

Active European Union

CE MDR CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD Number86838138HPOPSTRDEV7J Basic UDI-DI 08683813862021UDI-DIDate7 Oct 2026RegisteredStatusActive
European UnionCE/MDR Number86838138HPOPSTRDEV7J Basic UDI-DI 08683813862021UDI-DIDate7 Oct 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD, CE/MDR Active

Specification

EUDAMED

Device Name
30 L Single-Door Ozone Hydrogen Peroxide Plasma Sterilization Device
125 L Single-Door Ozone & Hydrogen Peroxide (H₂O₂) Plasma Sterilization Device
Model / Reference
3S30, 3S125
Primary DI / UDI-DI
08683813862021
Basic UDI-DI
86838138HPOPSTRDEV7J, B-08683813862021
Direct Marketing DI
08683813862021
EMDN Code
Z12011309 Plasma sterilisers
Device Class
Class IIa
Class IIb
EU market of registration
Romania

Manufacturer details

EUDAMED SRN
TR-MF-000037244

Other devices from B Science Bi̇yomedi̇kal Sanayi̇ Ve Ti̇caret Li̇mi̇ted Şi̇rketi̇

See all devices from B Science Bi̇yomedi̇kal Sanayi̇ Ve Ti̇caret Li̇mi̇ted Şi̇rketi̇ →

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