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Sümer

by Sümer Uluslararasi Sanayi̇ Ve Ti̇caret Anoni̇m Şi̇rketi̇ 319 variants

Model ELENA YKD 1 250 L

Sümer (---) is a Class IIb device made by Sümer Uluslararasi Sanayi̇ Ve Ti̇caret Anoni̇m Şi̇rketi̇, registered in EUDAMED on 14 May 2026 (Basic UDI-DI B-08698918582781), active as of 22 Oct 2026.

Active European Union

CE MDD

Valid until

No date given

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

Source EUDAMED, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08698918582781 Basic UDI-DI 08698918582781UDI-DIDate14 May 2026RegisteredStatusActive

Official records

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDD Active

Specification

EUDAMED

Device name
Elena Ykd 1 Tek Kapakli Yikama Dezenfeksi̇yon Ci̇hazi 250 L
Model / reference
ELENA YKD 1 250 L
Primary DI / UDI-DI
08698918582781
Basic UDI-DI
B-08698918582781
EMDN code
Z12011301 Cleaning and disinfection equipment
Device class
Class IIb
EU registration type
Legacy device (under a directive)
EU market of registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000022362

Related devices

Category: Surgical utensil washer/disinfector

Similar devices in this category

Other devices filed under CLEANING AND DISINFECTION EQUIPMENT.

Other devices from Sümer Uluslararasi Sanayi̇ Ve Ti̇caret Anoni̇m Şi̇rketi̇

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Properties

Other properties (12, all answered No)