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Eto C 1445

by Tekno Mar Maki̇na İmal.i̇th. İhr. San. Ti̇c. Ltd. Şti̇. 9 variants

Ref 125 Lt tank& cartridge, 125 Liter cylinders & cartridgeModel 125 Lt cylinders & cartridge, 80 Liter cylinders & Cartridge

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-08697400830232 Basic UDI-DI 08697400830232UDI-DIDate9 Oct 2026RegisteredStatusActive
European UnionCE/MDD NumberB-08697400830232 Basic UDI-DI 08697400830232UDI-DIDate9 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  • Withdrawn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
Ethylene Oxide Sterilization Device
Model / Reference
125 Lt cylinders & cartridge, 125 Lt tank& cartridge, 80 Liter cylinders & Cartridge, 125 Liter cylinders & cartridge
Primary DI / UDI-DI
08697400830232
Basic UDI-DI
B-08697400830232, 869740083ETOC14455U
Direct Marketing DI
08697400830232
EMDN Code
S9003 Devices for sterilisation with ethylene oxide (excluding cat. d - z)
Device Class
Class IIb
Class IIa
EU market of registration
Cyprus

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