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Sümer

by Sümer Uluslararasi Sanayi̇ Ve Ti̇caret Anoni̇m Şi̇rketi̇ 319 variants

Model ELENA YKD 2 360 L

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-08698918582675 Basic UDI-DI 08698918582675UDI-DIDate14 May 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  • Withdrawn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
Elena Ykd 2 Çi̇ft Kapakli Yikama Dezenfeksi̇yon Ci̇hazi 360 L
Model / Reference
ELENA YKD 2 360 L
Primary DI / UDI-DI
08698918582675
Basic UDI-DI
B-08698918582675
EMDN Code
Z12011301 Cleaning and disinfection equipment
Device Class
Class IIb
EU market of registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000022362

Other devices from Sümer Uluslararasi Sanayi̇ Ve Ti̇caret Anoni̇m Şi̇rketi̇

See all devices from Sümer Uluslararasi Sanayi̇ Ve Ti̇caret Anoni̇m 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