<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06926802603130</udiDi>
    <basicUdiDi>69268026MD71E00001VC</basicUdiDi>
    <tradeName>06926802603130</tradeName>
    <deviceName>hs-CRP+CRP（CLIA）</deviceName>
    <manufacturerName>MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000005925</manufacturerSrn>
    <authorisedRepresentativeName>R Sight B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000010445</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01021109</emdnCode>
    <emdnDescription>C-REACTIVE PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MCL02001E</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:41:02.014Z</lastUpdated>
  </row>
  <row>
    <udiDi>06926802602829</udiDi>
    <basicUdiDi>69268026HameaT4001MJ</basicUdiDi>
    <tradeName>Haemostasis Analyzer</tradeName>
    <deviceName>Haemostasis Analyzer</deviceName>
    <manufacturerName>MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000005925</manufacturerSrn>
    <authorisedRepresentativeName>R Sight B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000010445</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202029001</emdnCode>
    <emdnDescription>THROMBELASTOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Haema T4</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:40:55.606Z</lastUpdated>
  </row>
  <row>
    <udiDi>06926802602737</udiDi>
    <basicUdiDi>69268026ImmuF60001KS</basicUdiDi>
    <tradeName>Automated Chemiluminescence Immunoassay Analyzer</tradeName>
    <deviceName>Automated Chemiluminescence Immunoassay Analyzer</deviceName>
    <manufacturerName>MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000005925</manufacturerSrn>
    <authorisedRepresentativeName>R Sight B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000010445</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020101</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Immu F6</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:40:49.883Z</lastUpdated>
  </row>
  <row>
    <udiDi>06926802602690</udiDi>
    <basicUdiDi>69268026HameaTX001V7</basicUdiDi>
    <tradeName>Fully-automated Haemostasis Analyzer</tradeName>
    <deviceName>Fully-automated Haemostasis Analyzer</deviceName>
    <manufacturerName>MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000005925</manufacturerSrn>
    <authorisedRepresentativeName>R Sight B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000010445</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202029001</emdnCode>
    <emdnDescription>THROMBELASTOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Haema TX</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:40:38.744Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925661508013</udiDi>
    <basicUdiDi>69256615XSY01Z9</basicUdiDi>
    <tradeName>BT Liss</tradeName>
    <deviceName>BT Liss</deviceName>
    <manufacturerName>Shanghai Runpu Biotechnology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027207</manufacturerSrn>
    <authorisedRepresentativeName>R Sight B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000010445</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103030306</emdnCode>
    <emdnDescription>ENHANCEMENT MEDIA (E.G. BOVINE ALBUMIN, LISS, PEG)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2501-00085-01</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:27:06.934Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945121409766</udiDi>
    <basicUdiDi>69451214CardiacN6</basicUdiDi>
    <tradeName>CHISON</tradeName>
    <deviceName>ULTRASOUND PROBES</deviceName>
    <manufacturerName>CHISON Medical Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021605</manufacturerSrn>
    <authorisedRepresentativeName>R Sight B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000010445</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z110402010301</emdnCode>
    <emdnDescription>TRANSCUTANEOUS ULTRASOUND SECTOR PROBES (PHASED ARRAY), TWO–DIMENSIONAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P2-E</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:08:50.264Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945121409735</udiDi>
    <basicUdiDi>69451214SmallOrganSU</basicUdiDi>
    <tradeName>CHISON</tradeName>
    <deviceName>ULTRASOUND PROBES</deviceName>
    <manufacturerName>CHISON Medical Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021605</manufacturerSrn>
    <authorisedRepresentativeName>R Sight B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000010445</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z110402010101</emdnCode>
    <emdnDescription>TWO–DIMENSIONAL LINEAR–ARRAY TRANSCUTANEOUS ULTRASOUND PROBES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>L7-E</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:08:49.488Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945121409728</udiDi>
    <basicUdiDi>69451214Abdominal7Z</basicUdiDi>
    <tradeName>CHISON</tradeName>
    <deviceName>ULTRASOUND PROBES</deviceName>
    <manufacturerName>CHISON Medical Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021605</manufacturerSrn>
    <authorisedRepresentativeName>R Sight B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000010445</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z110402010201</emdnCode>
    <emdnDescription>CURVILINEAR TRANSCUTANEOUS TWO–DIMENSIONAL ULTRASOUND PROBES  (CONVEX–ARRAY)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C3S-E</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:08:47.880Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945121409889</udiDi>
    <basicUdiDi>69451214Abdominal7Z</basicUdiDi>
    <tradeName>CHISON</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CHISON Medical Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021605</manufacturerSrn>
    <authorisedRepresentativeName>R Sight B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000010445</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z110402010201</emdnCode>
    <emdnDescription>CURVILINEAR TRANSCUTANEOUS TWO–DIMENSIONAL ULTRASOUND PROBES  (CONVEX–ARRAY)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MC6-E</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-22T19:54:30.453Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945121409926</udiDi>
    <basicUdiDi>69451214SmallOrganSU</basicUdiDi>
    <tradeName>CHISON</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CHISON Medical Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021605</manufacturerSrn>
    <authorisedRepresentativeName>R Sight B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000010445</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z110402010101</emdnCode>
    <emdnDescription>TWO–DIMENSIONAL LINEAR–ARRAY TRANSCUTANEOUS ULTRASOUND PROBES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>L7-ES</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-22T19:52:57.698Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945121415880</udiDi>
    <basicUdiDi>69451214EBitUC</basicUdiDi>
    <tradeName>SonoGo</tradeName>
    <deviceName>Digital Color Doppler Ultrasound System</deviceName>
    <manufacturerName>CHISON Medical Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021605</manufacturerSrn>
    <authorisedRepresentativeName>R Sight B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000010445</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11040103</emdnCode>
    <emdnDescription>PORTABLE ULTRASOUND SCANNERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBit 90</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-17T20:47:53.505Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-211045-20-061CQ</udiDi>
    <basicUdiDi>B-211045-20-061CQ</basicUdiDi>
    <tradeName>KPC/IMP/NDM/VIM/OXA-48  Combo Test Kit (LFIA)</tradeName>
    <deviceName>KPC/IMP/NDM/VIM/OXA-48  Combo Test Kit (LFIA)</deviceName>
    <manufacturerName>Jiangsu Medomics Medical Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000030226</manufacturerSrn>
    <authorisedRepresentativeName>R Sight B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000010445</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0104080506</emdnCode>
    <emdnDescription>TARGETED RESISTANCE TESTS - CARBAPENEMASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>211045-20-061</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T22:49:45.821Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-211045-01-061C9</udiDi>
    <basicUdiDi>B-211045-01-061C9</basicUdiDi>
    <tradeName>KPC/IMP/NDM/VIM/OXA-48  Combo Test Kit (LFIA)</tradeName>
    <deviceName>KPC/IMP/NDM/VIM/OXA-48  Combo Test Kit (LFIA)</deviceName>
    <manufacturerName>Jiangsu Medomics Medical Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000030226</manufacturerSrn>
    <authorisedRepresentativeName>R Sight B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000010445</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0104080506</emdnCode>
    <emdnDescription>TARGETED RESISTANCE TESTS - CARBAPENEMASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>211045-01-061</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T22:49:45.015Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-U401HH</udiDi>
    <basicUdiDi>B-U401HH</basicUdiDi>
    <tradeName>Upnmed</tradeName>
    <deviceName>SpO2 Sensor</deviceName>
    <manufacturerName>Shenzhen UpnMed Equipment co.,ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000019212</manufacturerSrn>
    <authorisedRepresentativeName>R Sight B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000010445</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1203020685</emdnCode>
    <emdnDescription>VITAL SIGNS TELEMETRY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>U401-A, U401-B, U401-C, U401-D</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:27:32.163Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945121400145</udiDi>
    <basicUdiDi>69451214CBitTW</basicUdiDi>
    <tradeName>CHISON</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CHISON Medical Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021605</manufacturerSrn>
    <authorisedRepresentativeName>R Sight B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000010445</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z1104018099</emdnCode>
    <emdnDescription>ULTRASOUND SCANNERS – HARDWARE ACCESSORIES – OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D7L40L</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-09T17:37:54.265Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945121400244</udiDi>
    <basicUdiDi>69451214CBitTW</basicUdiDi>
    <tradeName>CHISON</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CHISON Medical Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021605</manufacturerSrn>
    <authorisedRepresentativeName>R Sight B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000010445</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z1104018099</emdnCode>
    <emdnDescription>ULTRASOUND SCANNERS – HARDWARE ACCESSORIES – OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D3P64L</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-09T17:37:54.244Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945121400305</udiDi>
    <basicUdiDi>69451214CBitTW</basicUdiDi>
    <tradeName>CHISON</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CHISON Medical Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021605</manufacturerSrn>
    <authorisedRepresentativeName>R Sight B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000010445</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z1104018099</emdnCode>
    <emdnDescription>ULTRASOUND SCANNERS – HARDWARE ACCESSORIES – OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D6C12L</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-09T17:37:54.220Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945121403245</udiDi>
    <basicUdiDi>69451214QBitWY</basicUdiDi>
    <tradeName>CHISON</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CHISON Medical Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021605</manufacturerSrn>
    <authorisedRepresentativeName>R Sight B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000010445</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z11040104</emdnCode>
    <emdnDescription>MULTIDISCIPLINARY ULTRASOUND SCANNERS (INTERNAL AND CARDIOLOGY, ETC.)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>QBit 7</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-09T17:37:54.173Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945121403269</udiDi>
    <basicUdiDi>69451214QBitWY</basicUdiDi>
    <tradeName>CHISON</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CHISON Medical Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021605</manufacturerSrn>
    <authorisedRepresentativeName>R Sight B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000010445</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z11040104</emdnCode>
    <emdnDescription>MULTIDISCIPLINARY ULTRASOUND SCANNERS (INTERNAL AND CARDIOLOGY, ETC.)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>QB it 9</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T17:37:54.155Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945121412308</udiDi>
    <basicUdiDi>69451214CBitTW</basicUdiDi>
    <tradeName>CHISON</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CHISON Medical Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021605</manufacturerSrn>
    <authorisedRepresentativeName>R Sight B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000010445</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z1104018099</emdnCode>
    <emdnDescription>MULTIDISCIPLINARY ULTRASOUND SCANNERS (INTERNAL AND CARDIOLOGY, ETC.)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CBit 8</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-09T17:37:54.112Z</lastUpdated>
  </row>
</eudamedExport>