<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08908025126069</udiDi>
    <basicUdiDi>8908025126OTLIGHTFIXWU</basicUdiDi>
    <tradeName>08908025126069</tradeName>
    <deviceName>Operation Theatre Light</deviceName>
    <manufacturerName>Surgical Equipment Co.</manufacturerName>
    <manufacturerSrn>IN-MF-000043933</manufacturerSrn>
    <authorisedRepresentativeName>OMC NI MEDICAL LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000019483</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12010701</emdnCode>
    <emdnDescription>FIXED SCIALYTIC LAMPS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>OCES-108E</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:08:46.359Z</lastUpdated>
  </row>
  <row>
    <udiDi>08907097389761</udiDi>
    <basicUdiDi>8907097DP320SaSD</basicUdiDi>
    <tradeName>NET</tradeName>
    <deviceName>X-Ray Viewer, LED Slim,  25mm Thickness, Four Film</deviceName>
    <manufacturerName>Narang Medical Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000018817</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12010780</emdnCode>
    <emdnDescription>SCIALYTIC LAMP LIGHTING SYSTEMS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DP320Sa</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:00:43.382Z</lastUpdated>
  </row>
  <row>
    <udiDi>08907097389754</udiDi>
    <basicUdiDi>8907097DP318SaTE</basicUdiDi>
    <tradeName>NET</tradeName>
    <deviceName>X-Ray Viewer, LED Slim,  25mm Thickness, Triple Film</deviceName>
    <manufacturerName>Narang Medical Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000018817</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12010780</emdnCode>
    <emdnDescription>SCIALYTIC LAMP LIGHTING SYSTEMS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DP318Sa</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:00:42.586Z</lastUpdated>
  </row>
  <row>
    <udiDi>89044281011086</udiDi>
    <basicUdiDi>8904428iLUXGG</basicUdiDi>
    <tradeName>Shalya iLUX 10</tradeName>
    <deviceName>Shalya iLUX 10</deviceName>
    <manufacturerName>Xcellance Medical Technologies Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000035259</manufacturerSrn>
    <authorisedRepresentativeName>Mars Medical</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006312</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12010701</emdnCode>
    <emdnDescription>FIXED SCIALYTIC LAMPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>L005</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:40:46.637Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809879610004</udiDi>
    <basicUdiDi>8809879610011GD</basicUdiDi>
    <tradeName>Head Light (KS-02)</tradeName>
    <deviceName>Head Light</deviceName>
    <manufacturerName>Saehanul Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000035588</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12010780</emdnCode>
    <emdnDescription>SCIALYTIC LAMP LIGHTING SYSTEMS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KS-02</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:00:39.583Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800205500013</udiDi>
    <basicUdiDi>88002055ML-5JN</basicUdiDi>
    <tradeName>Maestro LED Headlight</tradeName>
    <deviceName>Maestro</deviceName>
    <manufacturerName>Surgimag Co.,Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000034115</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12010799</emdnCode>
    <emdnDescription>SCIALYTIC LAMP LIGHTING SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SGM-P-ML5001</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:35:17.246Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800266945068</udiDi>
    <basicUdiDi>88000530E100BR</basicUdiDi>
    <tradeName>LUVIS</tradeName>
    <deviceName>Luminaire for diagnosis</deviceName>
    <manufacturerName>DENTIS CO., LTD</manufacturerName>
    <manufacturerSrn>KR-MF-000012523</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12010702</emdnCode>
    <emdnDescription>MOBILE SCIALYTIC LAMPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D-C-LVSL-V5-202602-ENG</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:30:47.321Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800053099301</udiDi>
    <basicUdiDi>88000530LM400B7</basicUdiDi>
    <tradeName>LUVIS</tradeName>
    <deviceName>Surgical Luminaire</deviceName>
    <manufacturerName>DENTIS CO., LTD</manufacturerName>
    <manufacturerSrn>KR-MF-000012523</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12010701</emdnCode>
    <emdnDescription>FIXED SCIALYTIC LAMPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D-C-LVSL-V5-202602-ENG</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:26:19.730Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800053095952</udiDi>
    <basicUdiDi>88000530M300DT</basicUdiDi>
    <tradeName>LUVIS</tradeName>
    <deviceName>Surgical Luminaire</deviceName>
    <manufacturerName>DENTIS CO., LTD</manufacturerName>
    <manufacturerSrn>KR-MF-000012523</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12010701</emdnCode>
    <emdnDescription>FIXED SCIALYTIC LAMPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D-C-LVSL-V5-202602-ENG</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:26:17.331Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800053094351</udiDi>
    <basicUdiDi>88000530LM200AV</basicUdiDi>
    <tradeName>LUVIS</tradeName>
    <deviceName>Surgical Luminaire</deviceName>
    <manufacturerName>DENTIS CO., LTD</manufacturerName>
    <manufacturerSrn>KR-MF-000012523</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12010701</emdnCode>
    <emdnDescription>FIXED SCIALYTIC LAMPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D-C-LVSL-V5-202602-ENG</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:26:15.731Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800053093767</udiDi>
    <basicUdiDi>88000530S300F5</basicUdiDi>
    <tradeName>LUVIS</tradeName>
    <deviceName>Surgical Luminaire</deviceName>
    <manufacturerName>DENTIS CO., LTD</manufacturerName>
    <manufacturerSrn>KR-MF-000012523</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12010701</emdnCode>
    <emdnDescription>FIXED SCIALYTIC LAMPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D-C-LVSL-V5-202602-ENG</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:26:14.933Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800053093644</udiDi>
    <basicUdiDi>88000530S250FF</basicUdiDi>
    <tradeName>LUVIS</tradeName>
    <deviceName>Surgical Luminaire</deviceName>
    <manufacturerName>DENTIS CO., LTD</manufacturerName>
    <manufacturerSrn>KR-MF-000012523</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12010701</emdnCode>
    <emdnDescription>FIXED SCIALYTIC LAMPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D-C-LVSM-V4-202510-ENG</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:26:13.324Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800053093460</udiDi>
    <basicUdiDi>88000530S200EY</basicUdiDi>
    <tradeName>LUVIS</tradeName>
    <deviceName>Surgical Luminaire</deviceName>
    <manufacturerName>DENTIS CO., LTD</manufacturerName>
    <manufacturerSrn>KR-MF-000012523</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12010701</emdnCode>
    <emdnDescription>FIXED SCIALYTIC LAMPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D-C-LVSL-V5-202602-ENG</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:26:10.935Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800017900056</udiDi>
    <basicUdiDi>88000179OPERATORYLIGHTWH</basicUdiDi>
    <tradeName>D6 Mobile</tradeName>
    <deviceName>D6</deviceName>
    <manufacturerName>DXM Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000016586</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12010701</emdnCode>
    <emdnDescription>FIXED SCIALYTIC LAMPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D6M</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:16:49.459Z</lastUpdated>
  </row>
  <row>
    <udiDi>08683517923103</udiDi>
    <basicUdiDi>8683517920203BH</basicUdiDi>
    <tradeName>ETKİN TIBBİ CİHAZLAR</tradeName>
    <deviceName>ETC LED SMYRNA+ 161X0SG/161X0SG DOUBLE HEAD CEILING LED SURGICAL LIGHT</deviceName>
    <manufacturerName>ETKİN TIBBİ CİHAZLAR SANAYİ VE TİCARET A.Ş.</manufacturerName>
    <manufacturerSrn>TR-MF-000016189</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12010701</emdnCode>
    <emdnDescription>FIXED SCIALYTIC LAMPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ETC LED ELITE 561M</reference>
    <placedOnMarketCountry>Slovakia</placedOnMarketCountry>
    <lastUpdated>2026-07-03T15:14:09.748Z</lastUpdated>
  </row>
  <row>
    <udiDi>08683517921246</udiDi>
    <basicUdiDi>8683517921403C2</basicUdiDi>
    <tradeName>ETKİN TIBBİ CİHAZLAR</tradeName>
    <deviceName>ETC LED ANKA+ 101-MZ MOBILE LED MINOR SURGERY LIGHT</deviceName>
    <manufacturerName>ETKİN TIBBİ CİHAZLAR SANAYİ VE TİCARET A.Ş.</manufacturerName>
    <manufacturerSrn>TR-MF-000016189</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12010702</emdnCode>
    <emdnDescription>MOBILE SCIALYTIC LAMPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ETC LED ANKA+ 101-MZ</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-03T15:14:08.951Z</lastUpdated>
  </row>
  <row>
    <udiDi>08435205000012</udiDi>
    <basicUdiDi>84352050FLH3L6</basicUdiDi>
    <tradeName>FLH-3 series</tradeName>
    <deviceName>FLH-3 series</deviceName>
    <manufacturerName>Ordisi, S.A</manufacturerName>
    <manufacturerSrn>ES-MF-000000987</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12010702</emdnCode>
    <emdnDescription>MOBILE SCIALYTIC LAMPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FLH311</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:45:11.463Z</lastUpdated>
  </row>
  <row>
    <udiDi>08058946990260</udiDi>
    <basicUdiDi>805894699LAMPADE22YA</basicUdiDi>
    <tradeName>SUN LED</tradeName>
    <deviceName>SUN LED</deviceName>
    <manufacturerName>S.M.D. S.R.L.</manufacturerName>
    <manufacturerSrn>IT-MF-000029648</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12010780</emdnCode>
    <emdnDescription>SCIALYTIC LAMP LIGHTING SYSTEMS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3945200</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:17:03.609Z</lastUpdated>
  </row>
  <row>
    <udiDi>08057502590456</udiDi>
    <basicUdiDi>805750259BALJG</basicUdiDi>
    <tradeName>BRACCIO ARTICOLATO A PARETE PER LAMPADA DA VISITA / DENTALE V2</tradeName>
    <deviceName>BRACCIO ARTICOLATO LAMPADA</deviceName>
    <manufacturerName>B&amp;D Bracci e dispositivi s.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000015845</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12010701</emdnCode>
    <emdnDescription>FIXED SCIALYTIC LAMPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BALLP2A3F3PL1</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T08:34:08.281Z</lastUpdated>
  </row>
  <row>
    <udiDi>08056093310665</udiDi>
    <basicUdiDi>805609331S3SMYLIGHTCS</basicUdiDi>
    <tradeName>MY LIGHT</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Silfradent S.R.L.</manufacturerName>
    <manufacturerSrn>IT-MF-000018668</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12010780</emdnCode>
    <emdnDescription>SCIALYTIC LAMP LIGHTING SYSTEMS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S3S EVO SS</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T08:03:50.872Z</lastUpdated>
  </row>
</eudamedExport>