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HRF3000

by Tekno Mar Maki̇na İmal.i̇th. İhr. San. Ti̇c. Ltd. Şti̇. 3 variants

Ref HRF 3000 S125Model 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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberB-08697400830133 Basic UDI-DI 08697400830133UDI-DIDate8 Oct 2026RegisteredStatusActive
European UnionCE/MDD NumberB-08697400830133 Basic UDI-DI 08697400830133UDI-DIDate8 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  • Withdrawn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/MDR, CE/MDD Active

Specification

EUDAMED

Device Name
125 L Single-Door Hydrogen Peroxide (H₂O₂) Plasma Sterilization Device
30 L Single-Door Hydrogen Peroxide (H2O2) Plasma Sterilization Device
Model / Reference
HRF 3000 S125, HRF 3000 S30
Primary DI / UDI-DI
08697400830133
Basic UDI-DI
B-08697400830133, 869740083HPPSTRDEVDK
Direct Marketing DI
08697400830133
EMDN Code
Z12011309 Plasma sterilisers
Device Class
Class IIb
Class IIa
EU market of registration
Romania

Manufacturer details

EUDAMED SRN
TR-MF-000017202

Other devices from Tekno Mar Maki̇na İmal.i̇th. İhr. San. Ti̇c. Ltd. Şti̇.

See all devices from Tekno Mar Maki̇na İmal.i̇th. İhr. San. Ti̇c. Ltd. Şti̇. →

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