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    <basicUdiDi>B-06944413809123</basicUdiDi>
    <tradeName>Controls</tradeName>
    <deviceName>Controls</deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050204</emdnCode>
    <emdnDescription>ELECTROLYTE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Hematocrit Control High</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:07:35.148Z</lastUpdated>
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    <udiDi>06944413809116</udiDi>
    <basicUdiDi>B-06944413809116</basicUdiDi>
    <tradeName>Controls</tradeName>
    <deviceName>Controls</deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050204</emdnCode>
    <emdnDescription>ELECTROLYTE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Hematocrit Control Low</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:07:33.755Z</lastUpdated>
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    <udiDi>06944413809093</udiDi>
    <basicUdiDi>B-06944413809093</basicUdiDi>
    <tradeName>Controls</tradeName>
    <deviceName>Controls</deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050204</emdnCode>
    <emdnDescription>ELECTROLYTE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Blood Gas and Electrolyte Control Level 3</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:07:32.138Z</lastUpdated>
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    <udiDi>06944413809086</udiDi>
    <basicUdiDi>B-06944413809086</basicUdiDi>
    <tradeName>Controls</tradeName>
    <deviceName>Controls</deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050204</emdnCode>
    <emdnDescription>ELECTROLYTE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Blood Gas and Electrolyte Control Level 2</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:07:29.099Z</lastUpdated>
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    <udiDi>06944413809079</udiDi>
    <basicUdiDi>B-06944413809079</basicUdiDi>
    <tradeName>Controls</tradeName>
    <deviceName>Controls</deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050204</emdnCode>
    <emdnDescription>ELECTROLYTE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Blood Gas and Electrolyte Control Level 1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:07:25.411Z</lastUpdated>
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    <udiDi>06944413809055</udiDi>
    <basicUdiDi>69444138UTGG</basicUdiDi>
    <tradeName>ultrasonic transducer</tradeName>
    <deviceName>ultrasonic transducer</deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</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>MC9-3TQ</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:07:24.002Z</lastUpdated>
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    <udiDi>06944413809031</udiDi>
    <basicUdiDi>69444138UTGG</basicUdiDi>
    <tradeName>ultrasonic transducer</tradeName>
    <deviceName>ultrasonic transducer</deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</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>P7-3Q</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:07:22.219Z</lastUpdated>
  </row>
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    <udiDi>06944413809000</udiDi>
    <basicUdiDi>69444138UTGG</basicUdiDi>
    <tradeName>ultrasonic transducer</tradeName>
    <deviceName>ultrasonic transducer</deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</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>P5-1Q</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:07:19.292Z</lastUpdated>
  </row>
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    <udiDi>06944413808812</udiDi>
    <basicUdiDi>69444138iM36M</basicUdiDi>
    <tradeName>Vital Signs Monitor</tradeName>
    <deviceName>Vital Signs Monitor</deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1203020202</emdnCode>
    <emdnDescription>TRANSPORTABLE/PORTABLE MULTI–PARAMETER PATIENT MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>iM3</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:07:17.111Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944413808980</udiDi>
    <basicUdiDi>69444138SE15SPT</basicUdiDi>
    <tradeName>Electrocardiograph</tradeName>
    <deviceName>Electrocardiograph</deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050301</emdnCode>
    <emdnDescription>GENERAL PURPOSE ELECTROCARDIOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SL18A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:07:14.666Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944413808966</udiDi>
    <basicUdiDi>69444138SE1201GE</basicUdiDi>
    <tradeName>Electrocardiograph</tradeName>
    <deviceName>Electrocardiograph</deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050301</emdnCode>
    <emdnDescription>GENERAL PURPOSE ELECTROCARDIOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SL12A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:07:12.311Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944413808911</udiDi>
    <basicUdiDi>69444138ECGCableEVU</basicUdiDi>
    <tradeName>ECG Cable</tradeName>
    <deviceName>ECG Cable</deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050380</emdnCode>
    <emdnDescription>ELECTROCARDIOGRAPHS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01.57.471877</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:07:09.290Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944413808904</udiDi>
    <basicUdiDi>69444138ECGCableEVU</basicUdiDi>
    <tradeName>ECG Cable</tradeName>
    <deviceName>ECG Cable</deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050380</emdnCode>
    <emdnDescription>ELECTROCARDIOGRAPHS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01.57.471876</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:07:06.818Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944413808393</udiDi>
    <basicUdiDi>69444138C3SYY</basicUdiDi>
    <tradeName>Video Colposcope</tradeName>
    <deviceName>Video Colposcope</deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12020703</emdnCode>
    <emdnDescription>COLPOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C6 HD</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:07:04.534Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944413808218</udiDi>
    <basicUdiDi>69444138UTGG</basicUdiDi>
    <tradeName>ultrasonic transducer</tradeName>
    <deviceName>ultrasonic transducer</deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</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>L12-5Q</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:07:02.469Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944413808409</udiDi>
    <basicUdiDi>69444138C3SYY</basicUdiDi>
    <tradeName>Video Colposcope</tradeName>
    <deviceName>Video Colposcope</deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12020703</emdnCode>
    <emdnDescription>COLPOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C6A HD</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:07:02.307Z</lastUpdated>
  </row>
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    <udiDi>06944413808768</udiDi>
    <basicUdiDi>69444138SD12Z</basicUdiDi>
    <tradeName>06944413808768</tradeName>
    <deviceName>Ultrasonic Pocket Doppler</deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12080103</emdnCode>
    <emdnDescription>FOETAL HEARTBEAT DETECTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SD1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:06:47.108Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944413808201</udiDi>
    <basicUdiDi>69444138UTGG</basicUdiDi>
    <tradeName>ultrasonic transducer</tradeName>
    <deviceName>ultrasonic transducer</deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</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>MC8-4Q</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:06:26.136Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944413808140</udiDi>
    <basicUdiDi>69444138SmartECGNetYE</basicUdiDi>
    <tradeName>Data Management Software</tradeName>
    <deviceName>Data Management Software</deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12030292</emdnCode>
    <emdnDescription>VITAL SIGNS MONITORING INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Smart ECG Net</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:06:20.178Z</lastUpdated>
  </row>
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    <udiDi>06944413807679</udiDi>
    <basicUdiDi>69444138SE2003SFG</basicUdiDi>
    <tradeName>Holter System</tradeName>
    <deviceName>Holter System</deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050403</emdnCode>
    <emdnDescription>ECG HOLTER RECORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SE-2003A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:06:12.723Z</lastUpdated>
  </row>
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