<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08885021260006</udiDi>
    <basicUdiDi>88850212601VJ</basicUdiDi>
    <tradeName>Syai</tradeName>
    <deviceName>Continuous Glucose Monitoring System</deviceName>
    <manufacturerName>SYAI HEALTH TECHNOLOGY PTE. LTD.</manufacturerName>
    <manufacturerSrn>SG-MF-000041645</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1204011585</emdnCode>
    <emdnDescription>INVASIVE BLOOD SUGAR MONITORING SYSTEMS, SINGLE–USE SENSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ST12024</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T21:11:37.652Z</lastUpdated>
  </row>
  <row>
    <udiDi>05021791007257</udiDi>
    <basicUdiDi>5021791FLS0003E3</basicUdiDi>
    <tradeName>FreeStyle Libre 3 Plus Continuous Glucose Monitoring System</tradeName>
    <deviceName>FreeStyle Libre 3 Continuous Glucose Monitoring System (Sensor Kit) / FreeStyle Libre 3 Plus Continuous Glucose Monitoring System (Sensor Kit) / Instinct sensor / Instinct Go sensor</deviceName>
    <manufacturerName>Abbott Diabetes Care Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000029309</manufacturerSrn>
    <authorisedRepresentativeName>Abbott B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000012577</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1204011585</emdnCode>
    <emdnDescription>INVASIVE BLOOD SUGAR MONITORING SYSTEMS, SINGLE–USE SENSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>78788-01</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:53:48.956Z</lastUpdated>
  </row>
  <row>
    <udiDi>05021791000876</udiDi>
    <basicUdiDi>5021791FLS0002DZ</basicUdiDi>
    <tradeName>FreeStyle Libre 2 Flash Glucose Monitoring System</tradeName>
    <deviceName>FreeStyle Libre 2 Flash Glucose Monitoring System (Sensor Kit) / FreeStyle Libre 2 Plus Flash Glucose Monitoring System (Sensor Kit) / FreeStyle Libre Select Continuous Glucose Monitoring Sensor</deviceName>
    <manufacturerName>Abbott Diabetes Care Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000029309</manufacturerSrn>
    <authorisedRepresentativeName>Abbott B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000012577</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1204011585</emdnCode>
    <emdnDescription>INVASIVE BLOOD SUGAR MONITORING SYSTEMS, SINGLE–USE SENSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>71988-01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:53:42.574Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719897812936</udiDi>
    <basicUdiDi>471094933CGM00009A2</basicUdiDi>
    <tradeName>RIGHTEST iFree2</tradeName>
    <deviceName>RIGHTEST iFree 2 Continuous Glucose Monitoring System Sensor kit</deviceName>
    <manufacturerName>Bionime Corporation</manufacturerName>
    <manufacturerSrn>TW-MF-000008450</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1204011585</emdnCode>
    <emdnDescription>INVASIVE BLOOD SUGAR MONITORING SYSTEMS, SINGLE–USE SENSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R0C066</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-29T23:38:25.523Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972831644002</udiDi>
    <basicUdiDi>697283164CGMGS3LQ</basicUdiDi>
    <tradeName>SIBIONICS GS3-R Continuous Glucose Monitoring System</tradeName>
    <deviceName>SIBIONICS GS3 Continuous Glucose Monitoring System</deviceName>
    <manufacturerName>Shenzhen SiSensing Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017945</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1204011585</emdnCode>
    <emdnDescription>INVASIVE BLOOD SUGAR MONITORING SYSTEMS, SINGLE–USE SENSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS3-R</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-27T22:12:45.343Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972831644019</udiDi>
    <basicUdiDi>697283164CGMGS3LQ</basicUdiDi>
    <tradeName>SIBIONICS GS3-R Continuous Glucose Monitoring System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen SiSensing Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017945</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1204011585</emdnCode>
    <emdnDescription>INVASIVE BLOOD SUGAR MONITORING SYSTEMS, SINGLE–USE SENSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS3-R</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-27T19:56:51.345Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719897811861</udiDi>
    <basicUdiDi>471094933CGM000079W</basicUdiDi>
    <tradeName>RIGHTEST iFree</tradeName>
    <deviceName>RIGHTEST iFree Continuous Glucose Monitoring System Sensor kit</deviceName>
    <manufacturerName>Bionime Corporation</manufacturerName>
    <manufacturerSrn>TW-MF-000008450</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1204011585</emdnCode>
    <emdnDescription>INVASIVE BLOOD SUGAR MONITORING SYSTEMS, SINGLE–USE SENSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R0C010</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-24T03:51:45.075Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972831643807</udiDi>
    <basicUdiDi>697283164CGMGS3LQ</basicUdiDi>
    <tradeName>SIBIONICS GS3-R Continuous Glucose Monitoring System</tradeName>
    <deviceName>SIBIONICS GS3 Continuous Glucose Monitoring System</deviceName>
    <manufacturerName>Shenzhen SiSensing Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017945</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1204011585</emdnCode>
    <emdnDescription>INVASIVE BLOOD SUGAR MONITORING SYSTEMS, SINGLE–USE SENSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS3-R</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T08:01:46.313Z</lastUpdated>
  </row>
  <row>
    <udiDi>00386270004598</udiDi>
    <basicUdiDi>038627DEXFLEX67</basicUdiDi>
    <tradeName>Dexcom Flex CGM System</tradeName>
    <deviceName>Dexcom Flex Continuous Glucose Monitoring System</deviceName>
    <manufacturerName>Dexcom</manufacturerName>
    <manufacturerSrn>US-MF-000010694</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1204011585</emdnCode>
    <emdnDescription>INVASIVE BLOOD SUGAR MONITORING SYSTEMS, SINGLE–USE SENSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>STP-DF-001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:45:42.278Z</lastUpdated>
  </row>
  <row>
    <udiDi>08885021260013</udiDi>
    <basicUdiDi>88850212601VJ</basicUdiDi>
    <tradeName>Syai</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SYAI HEALTH TECHNOLOGY PTE. LTD.</manufacturerName>
    <manufacturerSrn>SG-MF-000041645</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z1204011585</emdnCode>
    <emdnDescription>INVASIVE BLOOD SUGAR MONITORING SYSTEMS, SINGLE–USE SENSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SF12024</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:37:16.260Z</lastUpdated>
  </row>
  <row>
    <udiDi>08885021260037</udiDi>
    <basicUdiDi>88850212601VJ</basicUdiDi>
    <tradeName>Syai</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SYAI HEALTH TECHNOLOGY PTE. LTD.</manufacturerName>
    <manufacturerSrn>SG-MF-000041645</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z1204011585</emdnCode>
    <emdnDescription>INVASIVE BLOOD SUGAR MONITORING SYSTEMS, SINGLE–USE SENSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ST12024</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:37:16.235Z</lastUpdated>
  </row>
  <row>
    <udiDi>08885021260051</udiDi>
    <basicUdiDi>88850212601VJ</basicUdiDi>
    <tradeName>Syai</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SYAI HEALTH TECHNOLOGY PTE. LTD.</manufacturerName>
    <manufacturerSrn>SG-MF-000041645</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z1204011585</emdnCode>
    <emdnDescription>INVASIVE BLOOD SUGAR MONITORING SYSTEMS, SINGLE–USE SENSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ST12024</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:37:16.195Z</lastUpdated>
  </row>
  <row>
    <udiDi>08885021260112</udiDi>
    <basicUdiDi>88850212601VJ</basicUdiDi>
    <tradeName>08885021260112</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SYAI HEALTH TECHNOLOGY PTE. LTD.</manufacturerName>
    <manufacturerSrn>SG-MF-000041645</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z1204011585</emdnCode>
    <emdnDescription>INVASIVE BLOOD SUGAR MONITORING SYSTEMS, SINGLE–USE SENSORS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>X1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:37:16.173Z</lastUpdated>
  </row>
  <row>
    <udiDi>08885021260129</udiDi>
    <basicUdiDi>88850212601VJ</basicUdiDi>
    <tradeName>08885021260129</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SYAI HEALTH TECHNOLOGY PTE. LTD.</manufacturerName>
    <manufacturerSrn>SG-MF-000041645</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z1204011585</emdnCode>
    <emdnDescription>INVASIVE BLOOD SUGAR MONITORING SYSTEMS, SINGLE–USE SENSORS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>M8</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:37:16.144Z</lastUpdated>
  </row>
  <row>
    <udiDi>16973018100172</udiDi>
    <basicUdiDi>B-16973018100172</basicUdiDi>
    <tradeName>Glunovo</tradeName>
    <deviceName>Sensors of Continuous Glucose Monitoring Systems</deviceName>
    <manufacturerName>INFINOVO MEDICAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000020571</manufacturerSrn>
    <authorisedRepresentativeName>Llins Service &amp; Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000009077</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1204011585</emdnCode>
    <emdnDescription>INVASIVE BLOOD SUGAR MONITORING SYSTEMS, SINGLE–USE SENSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CP04010201</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T06:53:22.950Z</lastUpdated>
  </row>
  <row>
    <udiDi>16973018100080</udiDi>
    <basicUdiDi>B-16973018100080</basicUdiDi>
    <tradeName>Glunovo</tradeName>
    <deviceName>Sensors of Continuous Glucose Monitoring Systems</deviceName>
    <manufacturerName>INFINOVO MEDICAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000020571</manufacturerSrn>
    <authorisedRepresentativeName>Llins Service &amp; Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000009077</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1204011585</emdnCode>
    <emdnDescription>INVASIVE BLOOD SUGAR MONITORING SYSTEMS, SINGLE–USE SENSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CP03010203</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T06:53:18.943Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971123680841</udiDi>
    <basicUdiDi>B-06971123680841</basicUdiDi>
    <tradeName>Glucose Sensor</tradeName>
    <deviceName>Glucose Sensor</deviceName>
    <manufacturerName>Medtrum Technologies Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000001942</manufacturerSrn>
    <authorisedRepresentativeName>Medtrum B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000595</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1204011585</emdnCode>
    <emdnDescription>INVASIVE BLOOD SUGAR MONITORING SYSTEMS, SINGLE–USE SENSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MD3026</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:10:02.075Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971123680797</udiDi>
    <basicUdiDi>B-06971123680797</basicUdiDi>
    <tradeName>Glucose Sensor</tradeName>
    <deviceName>Glucose Sensor</deviceName>
    <manufacturerName>Medtrum Technologies Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000001942</manufacturerSrn>
    <authorisedRepresentativeName>Medtrum B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000595</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1204011585</emdnCode>
    <emdnDescription>INVASIVE BLOOD SUGAR MONITORING SYSTEMS, SINGLE–USE SENSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MD-JY-006+</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:10:01.279Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971123680773</udiDi>
    <basicUdiDi>B-06971123680773</basicUdiDi>
    <tradeName>Glucose Sensor</tradeName>
    <deviceName>Glucose Sensor</deviceName>
    <manufacturerName>Medtrum Technologies Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000001942</manufacturerSrn>
    <authorisedRepresentativeName>Medtrum B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000595</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1204011585</emdnCode>
    <emdnDescription>INVASIVE BLOOD SUGAR MONITORING SYSTEMS, SINGLE–USE SENSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MD3658</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:09:57.267Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971123680766</udiDi>
    <basicUdiDi>B-06971123680766</basicUdiDi>
    <tradeName>Glucose Sensor</tradeName>
    <deviceName>Glucose Sensor</deviceName>
    <manufacturerName>Medtrum Technologies Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000001942</manufacturerSrn>
    <authorisedRepresentativeName>Medtrum B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000595</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1204011585</emdnCode>
    <emdnDescription>INVASIVE BLOOD SUGAR MONITORING SYSTEMS, SINGLE–USE SENSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MD3658</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:09:55.669Z</lastUpdated>
  </row>
</eudamedExport>