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Etki̇n Tibbi̇ Ci̇hazlar

by Etki̇n Tibbi̇ Ci̇hazlar Sanayi̇ Ve Ti̇caret A.Ş. 6 variants

Ref ETC LED ELITE 561M

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

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 Number8683517920203BH Basic UDI-DI 08683517923103UDI-DIDate5 Jun 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Etc LED Smyrna+ 161X0SG/161X0SG Double Head Ceiling LED Surgical Light
Model / Reference
ETC LED ELITE 561M
Primary DI / UDI-DI
08683517923103
Basic UDI-DI
8683517920203BH
EMDN Code
Z12010701 Fixed scialytic lamps
Device Class
Class I
EU market of registration
Slovakia

Manufacturer details

EUDAMED SRN
TR-MF-000016189

Other devices from Etki̇n Tibbi̇ Ci̇hazlar Sanayi̇ Ve Ti̇caret A.Ş.

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