<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>16974471530025</udiDi>
    <basicUdiDi>697447153002L8</basicUdiDi>
    <tradeName>Medical lights</tradeName>
    <deviceName>Medical lights</deviceName>
    <manufacturerName>Shantou Easywell Electronic Technologies Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000016725</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002066</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12010702</emdnCode>
    <emdnDescription>MOBILE SCIALYTIC LAMPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KS-Q5</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-02T13:12:37.954Z</lastUpdated>
  </row>
  <row>
    <udiDi>16974471530018</udiDi>
    <basicUdiDi>697447153001L6</basicUdiDi>
    <tradeName>Medical lights</tradeName>
    <deviceName>Medical lights</deviceName>
    <manufacturerName>Shantou Easywell Electronic Technologies Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000016725</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002066</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12010702</emdnCode>
    <emdnDescription>MOBILE SCIALYTIC LAMPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KS-Q3</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-02T13:12:37.239Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974445421000</udiDi>
    <basicUdiDi>697444542HE700/500JK</basicUdiDi>
    <tradeName>HOWELL</tradeName>
    <deviceName>Shadowless Operating Lamp</deviceName>
    <manufacturerName>Harbin Howell Medical Apparatus and Instruments Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025141</manufacturerSrn>
    <authorisedRepresentativeName>Caretechion GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005946</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12010701</emdnCode>
    <emdnDescription>FIXED SCIALYTIC LAMPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HE-L500</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T13:08:12.708Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974423970001</udiDi>
    <basicUdiDi>697442397Light001LQ</basicUdiDi>
    <tradeName>06974423970001</tradeName>
    <deviceName>Operating Light</deviceName>
    <manufacturerName>HEFEI HEALTH SCIENCE AND TECHNOLOGY DEVELOPMENT CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000011677</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</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>LEDD700/700</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T13:00:04.845Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974193970225</udiDi>
    <basicUdiDi>697419397MH001KQ</basicUdiDi>
    <tradeName>06974193970225</tradeName>
    <deviceName>medical headlight</deviceName>
    <manufacturerName>NANTONG HEALTHCARE MEDICAL INSTRUMENT CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000050033</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12010799</emdnCode>
    <emdnDescription>SCIALYTIC LAMP LIGHTING SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HCM 6690</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T12:38:16.526Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972933621420</udiDi>
    <basicUdiDi>697293362CF002DA</basicUdiDi>
    <tradeName>Headlights</tradeName>
    <deviceName>Headlights</deviceName>
    <manufacturerName>Chamfond Biotech Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000024191</manufacturerSrn>
    <authorisedRepresentativeName>Llins Service &amp; Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000009077</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12010702</emdnCode>
    <emdnDescription>MOBILE SCIALYTIC LAMPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SC-YFLED-K2000</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T10:21:32.598Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972733990535</udiDi>
    <basicUdiDi>697273399010702MSL7P</basicUdiDi>
    <tradeName>Surgical Lights</tradeName>
    <deviceName>Surgical Lights</deviceName>
    <manufacturerName>HEYER Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014712</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12010702</emdnCode>
    <emdnDescription>MOBILE SCIALYTIC LAMPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>118000053</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T10:08:28.150Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972733990382</udiDi>
    <basicUdiDi>697273399010701FSL6D</basicUdiDi>
    <tradeName>Surgical Lights</tradeName>
    <deviceName>Surgical Lights</deviceName>
    <manufacturerName>HEYER Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014712</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12010701</emdnCode>
    <emdnDescription>FIXED SCIALYTIC LAMPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>118000038</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T10:08:27.343Z</lastUpdated>
  </row>
  <row>
    <udiDi>05051223008507</udiDi>
    <basicUdiDi>50512230LHANDLE6X</basicUdiDi>
    <tradeName>Universal Light Handle, for use with ‘Getinge/CASTLE-GRAY2300-2400-2800</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Purple Surgical Holdings Limited also known as Purple Surgical International Limited, Purple Surgical UK Limited and Purple Surgical Manufacturing Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000012819</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12010780</emdnCode>
    <emdnDescription>SCIALYTIC LAMP LIGHTING SYSTEMS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PS9901</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T10:05:25.768Z</lastUpdated>
  </row>
  <row>
    <udiDi>05051223008514</udiDi>
    <basicUdiDi>50512230LHANDLE6X</basicUdiDi>
    <tradeName>Universal Light Handle, for use with ‘AMSCO</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Purple Surgical Holdings Limited also known as Purple Surgical International Limited, Purple Surgical UK Limited and Purple Surgical Manufacturing Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000012819</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12010780</emdnCode>
    <emdnDescription>SCIALYTIC LAMP LIGHTING SYSTEMS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PS9902</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T10:05:25.749Z</lastUpdated>
  </row>
  <row>
    <udiDi>05051223008521</udiDi>
    <basicUdiDi>50512230LHANDLE6X</basicUdiDi>
    <tradeName>Universal Light Handle, for use with ‘AMSCO SQ240</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Purple Surgical Holdings Limited also known as Purple Surgical International Limited, Purple Surgical UK Limited and Purple Surgical Manufacturing Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000012819</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12010780</emdnCode>
    <emdnDescription>SCIALYTIC LAMP LIGHTING SYSTEMS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PS9902A</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T10:05:25.727Z</lastUpdated>
  </row>
  <row>
    <udiDi>05051223008538</udiDi>
    <basicUdiDi>50512230LHANDLE6X</basicUdiDi>
    <tradeName>Universal Light Handle, for use with ‘Steris Harmony</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Purple Surgical Holdings Limited also known as Purple Surgical International Limited, Purple Surgical UK Limited and Purple Surgical Manufacturing Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000012819</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12010780</emdnCode>
    <emdnDescription>SCIALYTIC LAMP LIGHTING SYSTEMS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PS9902H</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T10:05:25.708Z</lastUpdated>
  </row>
  <row>
    <udiDi>05051223008545</udiDi>
    <basicUdiDi>50512230LHANDLE6X</basicUdiDi>
    <tradeName>Universal Light Handle, for use with ‘AMSCO QUANTUM’</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Purple Surgical Holdings Limited also known as Purple Surgical International Limited, Purple Surgical UK Limited and Purple Surgical Manufacturing Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000012819</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12010780</emdnCode>
    <emdnDescription>SCIALYTIC LAMP LIGHTING SYSTEMS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PS9902Q</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T10:05:25.689Z</lastUpdated>
  </row>
  <row>
    <udiDi>05051223008552</udiDi>
    <basicUdiDi>50512230LHANDLE6X</basicUdiDi>
    <tradeName>Universal Light Handle, for use with ‘Getinge-Castle 2500-290’</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Purple Surgical Holdings Limited also known as Purple Surgical International Limited, Purple Surgical UK Limited and Purple Surgical Manufacturing Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000012819</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12010780</emdnCode>
    <emdnDescription>SCIALYTIC LAMP LIGHTING SYSTEMS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PS9903</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T10:05:25.669Z</lastUpdated>
  </row>
  <row>
    <udiDi>05051223008569</udiDi>
    <basicUdiDi>50512230LHANDLE6X</basicUdiDi>
    <tradeName>Universal Light Handle, for use with ‘CASTLE-SQUARE’</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Purple Surgical Holdings Limited also known as Purple Surgical International Limited, Purple Surgical UK Limited and Purple Surgical Manufacturing Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000012819</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12010780</emdnCode>
    <emdnDescription>SCIALYTIC LAMP LIGHTING SYSTEMS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PS9904</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T10:05:25.646Z</lastUpdated>
  </row>
  <row>
    <udiDi>05051223008576</udiDi>
    <basicUdiDi>50512230LHANDLE6X</basicUdiDi>
    <tradeName>Universal Light Handle, for use with ‘CASTLE-DEEP’</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Purple Surgical Holdings Limited also known as Purple Surgical International Limited, Purple Surgical UK Limited and Purple Surgical Manufacturing Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000012819</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12010780</emdnCode>
    <emdnDescription>SCIALYTIC LAMP LIGHTING SYSTEMS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PS9905</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T10:05:25.626Z</lastUpdated>
  </row>
  <row>
    <udiDi>05051223008583</udiDi>
    <basicUdiDi>50512230LHANDLE6X</basicUdiDi>
    <tradeName>Universal Light Handle, for use with ‘Skytron green Excel major’</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Purple Surgical Holdings Limited also known as Purple Surgical International Limited, Purple Surgical UK Limited and Purple Surgical Manufacturing Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000012819</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12010780</emdnCode>
    <emdnDescription>SCIALYTIC LAMP LIGHTING SYSTEMS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PS9906</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T10:05:25.604Z</lastUpdated>
  </row>
  <row>
    <udiDi>05051223008590</udiDi>
    <basicUdiDi>50512230LHANDLE6X</basicUdiDi>
    <tradeName>Universal Light Handle, for use with ‘SKYTRON-W/RING’</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Purple Surgical Holdings Limited also known as Purple Surgical International Limited, Purple Surgical UK Limited and Purple Surgical Manufacturing Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000012819</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12010780</emdnCode>
    <emdnDescription>SCIALYTIC LAMP LIGHTING SYSTEMS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PS9907</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T10:05:25.581Z</lastUpdated>
  </row>
  <row>
    <udiDi>05051223008606</udiDi>
    <basicUdiDi>50512230LHANDLE6X</basicUdiDi>
    <tradeName>Universal Light Handle, for use with  ‘ASSY, SKYTRON UNIVERSE infinity FC’</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Purple Surgical Holdings Limited also known as Purple Surgical International Limited, Purple Surgical UK Limited and Purple Surgical Manufacturing Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000012819</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12010780</emdnCode>
    <emdnDescription>SCIALYTIC LAMP LIGHTING SYSTEMS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PS9907E</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T10:05:25.568Z</lastUpdated>
  </row>
  <row>
    <udiDi>05051223008613</udiDi>
    <basicUdiDi>50512230LHANDLE6X</basicUdiDi>
    <tradeName>Universal Light Handle, for use with ‘SKYTRON-W/CROSS SKYTRON-Nova TIP’</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Purple Surgical Holdings Limited also known as Purple Surgical International Limited, Purple Surgical UK Limited and Purple Surgical Manufacturing Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000012819</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12010780</emdnCode>
    <emdnDescription>SCIALYTIC LAMP LIGHTING SYSTEMS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PS9907N</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T10:05:25.551Z</lastUpdated>
  </row>
</eudamedExport>