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HRF3000

by B Science Bi̇yomedi̇kal Sanayi̇ Ve Ti̇caret Li̇mi̇ted Şi̇rketi̇ 7 variants

Ref STEKModel HRF 3000 STEK

Active European Union

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 NumberB-08683813860133 Basic UDI-DI 08683813860133UDI-DIDate6 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  • Withdrawn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 Active

Specification

EUDAMED

Device Name
Single-Door Hydrogen Peroxide (H₂O₂) Plasma Sterilization Device
Model / Reference
HRF 3000 STEK, STEK
Primary DI / UDI-DI
08683813860133
Basic UDI-DI
B-08683813860133
EMDN Code
Z12011309 Plasma sterilisers
Device Class
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 (11)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No