<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06950715506707</udiDi>
    <basicUdiDi>69507155XYY86</basicUdiDi>
    <tradeName>Pulse oximeter</tradeName>
    <deviceName>Pulse Oximeter</deviceName>
    <manufacturerName>Cofoe Medical Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001077</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1203020408</emdnCode>
    <emdnDescription>PULSE OXIMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OXH88</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T05:56:17.185Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950715506691</udiDi>
    <basicUdiDi>69507155XYY86</basicUdiDi>
    <tradeName>Pulse oximeter</tradeName>
    <deviceName>Pulse Oximeter</deviceName>
    <manufacturerName>Cofoe Medical Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001077</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1203020408</emdnCode>
    <emdnDescription>PULSE OXIMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OHT80</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T05:56:11.165Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950715506059</udiDi>
    <basicUdiDi>69507155XYY86</basicUdiDi>
    <tradeName>Pulsioxímetro</tradeName>
    <deviceName>Pulse Oximeter</deviceName>
    <manufacturerName>Cofoe Medical Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001077</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1203020408</emdnCode>
    <emdnDescription>PULSE OXIMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OHT60</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T05:56:09.964Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950715506042</udiDi>
    <basicUdiDi>69507155BSXYJV2</basicUdiDi>
    <tradeName>Tensiómetro automático de brazo</tradeName>
    <deviceName>Automatic Upper Arm Blood Pressure Monitor</deviceName>
    <manufacturerName>Cofoe Medical Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001077</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1203020501</emdnCode>
    <emdnDescription>NON–INVASIVE OSCILLOMETRIC BLOOD PRESSURE GAUGES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KF-65B</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T05:56:08.757Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950715506028</udiDi>
    <basicUdiDi>69507155HWXTWJ4C</basicUdiDi>
    <tradeName>Infrared Thermometer</tradeName>
    <deviceName>Infrared Thermometer</deviceName>
    <manufacturerName>Cofoe Medical Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001077</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V03010199</emdnCode>
    <emdnDescription>THERMOMETERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KF-HW-005</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-06-28T05:56:07.582Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950715506011</udiDi>
    <basicUdiDi>69507155HWXTWJ4C</basicUdiDi>
    <tradeName>Infrared Thermometer</tradeName>
    <deviceName>Infrared Thermometer</deviceName>
    <manufacturerName>Cofoe Medical Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001077</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V03010199</emdnCode>
    <emdnDescription>THERMOMETERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KF-HW-005</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-06-28T05:56:01.559Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950715504499</udiDi>
    <basicUdiDi>69507155OBEF</basicUdiDi>
    <tradeName>Ostomy Bag and Accessories</tradeName>
    <deviceName>Ostomy Bag and Accessories</deviceName>
    <manufacturerName>Cofoe Medical Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001077</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A1001020101</emdnCode>
    <emdnDescription>ONE-PIECE ILEOSTOMY BAGS FOR NON-RETRACTED STOMA, FLAT, W/O TISSUE COVER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>One-piece Drainable IIeostomy Bag</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-28T05:56:00.353Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950715504482</udiDi>
    <basicUdiDi>69507155OBEF</basicUdiDi>
    <tradeName>Ostomy Bag and Accessories</tradeName>
    <deviceName>Ostomy Bag and Accessories</deviceName>
    <manufacturerName>Cofoe Medical Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001077</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A1001020101</emdnCode>
    <emdnDescription>ONE-PIECE ILEOSTOMY BAGS FOR NON-RETRACTED STOMA, FLAT, W/O TISSUE COVER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>One-piece Drainable IIeostomy Bag</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-28T05:55:59.153Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950715503348</udiDi>
    <basicUdiDi>695071556GHJPF</basicUdiDi>
    <tradeName>Neck Brace</tradeName>
    <deviceName>Neck Brace</deviceName>
    <manufacturerName>Cofoe Medical Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001077</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y060312</emdnCode>
    <emdnDescription>CERVICAL SPINE ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KF-JB05</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-28T05:55:57.950Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950715503331</udiDi>
    <basicUdiDi>695071556GHJPF</basicUdiDi>
    <tradeName>Neck Brace</tradeName>
    <deviceName>Neck Brace</deviceName>
    <manufacturerName>Cofoe Medical Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001077</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y060312</emdnCode>
    <emdnDescription>CERVICAL SPINE ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>J01-CL-01</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-28T05:55:51.948Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950715501030</udiDi>
    <basicUdiDi>B-06950715501030</basicUdiDi>
    <tradeName>Blood Glucose Meter</tradeName>
    <deviceName>Blood Glucose Meter</deviceName>
    <manufacturerName>Cofoe Medical Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001077</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KFA108</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T05:55:50.769Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950715501023</udiDi>
    <basicUdiDi>69507155YSSWHQ8A</basicUdiDi>
    <tradeName>Compressor Nebulizer</tradeName>
    <deviceName>Compressor Nebulizer</deviceName>
    <manufacturerName>Cofoe Medical Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001077</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12159002</emdnCode>
    <emdnDescription>AEROSOL EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KF-WHQ-09</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T05:55:49.541Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950715501016</udiDi>
    <basicUdiDi>69507155YSSWHQ8A</basicUdiDi>
    <tradeName>Compressor Nebulizer</tradeName>
    <deviceName>Compressor Nebulizer</deviceName>
    <manufacturerName>Cofoe Medical Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001077</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12159002</emdnCode>
    <emdnDescription>AEROSOL EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KF-WHQ-08</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-28T05:55:48.345Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950715501009</udiDi>
    <basicUdiDi>69507155YSSWHQ8A</basicUdiDi>
    <tradeName>Compressor Nebulizer</tradeName>
    <deviceName>Compressor Nebulizer</deviceName>
    <manufacturerName>Cofoe Medical Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001077</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12159002</emdnCode>
    <emdnDescription>AEROSOL EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KF-WHQ-07</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-28T05:55:42.335Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950715500996</udiDi>
    <basicUdiDi>69507155YSSWHQ8A</basicUdiDi>
    <tradeName>Compressor Nebulizer</tradeName>
    <deviceName>Compressor Nebulizer</deviceName>
    <manufacturerName>Cofoe Medical Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001077</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12159002</emdnCode>
    <emdnDescription>AEROSOL EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KF-WHQ-02</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-28T05:55:41.167Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950715500989</udiDi>
    <basicUdiDi>69507155YSSWHQ8A</basicUdiDi>
    <tradeName>Compressor Nebulizer</tradeName>
    <deviceName>Compressor Nebulizer</deviceName>
    <manufacturerName>Cofoe Medical Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001077</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12159002</emdnCode>
    <emdnDescription>AEROSOL EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KF-WHQ-01</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-06-28T05:55:39.932Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950715500972</udiDi>
    <basicUdiDi>69507155WSWHQ32</basicUdiDi>
    <tradeName>Mesh Nebulizer</tradeName>
    <deviceName>Mesh Nebulizer</deviceName>
    <manufacturerName>Cofoe Medical Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001077</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12159002</emdnCode>
    <emdnDescription>AEROSOL EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KF-WHQ-603B</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-28T05:55:38.737Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950715500965</udiDi>
    <basicUdiDi>69507155WSWHQ32</basicUdiDi>
    <tradeName>Mesh Nebulizer</tradeName>
    <deviceName>Mesh Nebulizer</deviceName>
    <manufacturerName>Cofoe Medical Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001077</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12159002</emdnCode>
    <emdnDescription>AEROSOL EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KF-WHQ-601B</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T05:55:32.734Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950715500880</udiDi>
    <basicUdiDi>B-06950715500880</basicUdiDi>
    <tradeName>HCG Pregnancy Test</tradeName>
    <deviceName>HCG Pregnancy Test</deviceName>
    <manufacturerName>Cofoe Medical Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001077</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KFA409</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T05:55:31.555Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950715500859</udiDi>
    <basicUdiDi>B-06950715500859</basicUdiDi>
    <tradeName>HCG Pregnancy Test</tradeName>
    <deviceName>HCG Pregnancy Test</deviceName>
    <manufacturerName>Cofoe Medical Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001077</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KFA406</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T05:55:30.330Z</lastUpdated>
  </row>
</eudamedExport>