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HRF3000

by B Science Bi̇yomedi̇kal Sanayi̇ Ve Ti̇caret Li̇mi̇ted Şi̇rketi̇ 7 variants

Ref D75Model HRF 3000 D75, HRF 3000 S30

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/MDR NumberB-08683813860041 Basic UDI-DI 08683813860041UDI-DIDate24 Sep 2026RegisteredStatusActive
European UnionCE/MDD NumberB-08683813860041 Basic UDI-DI 08683813860041UDI-DIDate24 Sep 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  • Withdrawn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/MDR, CE/MDD Active

Specification

EUDAMED

Device Name
75 L Double-Door Hydrogen Peroxide (H₂O₂) Plasma Sterilization Device
30 L Single-Door Hydrogen Peroxide (H2O2) Plasma Sterilization Device
Model / Reference
HRF 3000 D75, D75, HRF 3000 S30
Primary DI / UDI-DI
08683813860041
Basic UDI-DI
B-08683813860041, 86838138HPPSTRDEVFD
Direct Marketing DI
08683813860041
EMDN Code
Z12011309 Plasma sterilisers
Device Class
Class IIb
Class IIa
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