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    <udiDi>06944413835504</udiDi>
    <basicUdiDi>69444138AcclarixGX9SD8</basicUdiDi>
    <tradeName>Diagnostic Ultrasound System</tradeName>
    <deviceName>Diagnostic Ultrasound 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>Z11040101</emdnCode>
    <emdnDescription>INTERNAL ULTRASOUND SCANNERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Acclarix GX9 Exp</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:36:37.842Z</lastUpdated>
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    <udiDi>06944413835498</udiDi>
    <basicUdiDi>69444138AcclarixGX9SD8</basicUdiDi>
    <tradeName>Diagnostic Ultrasound System</tradeName>
    <deviceName>Diagnostic Ultrasound 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>Z11040101</emdnCode>
    <emdnDescription>INTERNAL ULTRASOUND SCANNERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Acclarix GX9</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:36:35.573Z</lastUpdated>
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    <udiDi>06944413835474</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>Z1104020201</emdnCode>
    <emdnDescription>ENDOCAVITARY ULTRASOUND PROBES, TWO–DIMENSIONAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>E10-3Q</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:36:34.233Z</lastUpdated>
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    <udiDi>06944413835467</udiDi>
    <basicUdiDi>69444138ConCableBK</basicUdiDi>
    <tradeName>Connection Cable</tradeName>
    <deviceName>Connection 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>Z12030280</emdnCode>
    <emdnDescription>VITAL SIGNS MONITORING INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IBP12HO11</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:36:30.622Z</lastUpdated>
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    <udiDi>06944413835450</udiDi>
    <basicUdiDi>69444138ConCableBK</basicUdiDi>
    <tradeName>Connection Cable</tradeName>
    <deviceName>Connection 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>Z12030280</emdnCode>
    <emdnDescription>VITAL SIGNS MONITORING INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IBP12ED11</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:36:27.036Z</lastUpdated>
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    <udiDi>06944413835436</udiDi>
    <basicUdiDi>69444138H80SPS</basicUdiDi>
    <tradeName>Hematology Analyzer</tradeName>
    <deviceName>Hematology Analyzer</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 Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202010101</emdnCode>
    <emdnDescription>AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 samples/hr)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H88S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:36:24.623Z</lastUpdated>
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    <udiDi>06944413835429</udiDi>
    <basicUdiDi>69444138H80SPS</basicUdiDi>
    <tradeName>Hematology Analyzer</tradeName>
    <deviceName>Hematology Analyzer</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 Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202010101</emdnCode>
    <emdnDescription>AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 samples/hr)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H88</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:36:23.422Z</lastUpdated>
  </row>
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    <udiDi>06944413835412</udiDi>
    <basicUdiDi>69444138H80SPS</basicUdiDi>
    <tradeName>Hematology Analyzer</tradeName>
    <deviceName>Hematology Analyzer</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 Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202010101</emdnCode>
    <emdnDescription>AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 samples/hr)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H80S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:36:21.035Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944413835405</udiDi>
    <basicUdiDi>69444138H80SPS</basicUdiDi>
    <tradeName>Hematology Analyzer</tradeName>
    <deviceName>Hematology Analyzer</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 Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202010101</emdnCode>
    <emdnDescription>AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 samples/hr)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H80</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:36:17.438Z</lastUpdated>
  </row>
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    <udiDi>06944413835344</udiDi>
    <basicUdiDi>69444138Neptune8E</basicUdiDi>
    <tradeName>Patient Monitor</tradeName>
    <deviceName>Patient 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>Z1203020201</emdnCode>
    <emdnDescription>MULTI–PARAMETER PATIENT BEDSIDE MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Neptune</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:36:14.250Z</lastUpdated>
  </row>
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    <udiDi>06944413835276</udiDi>
    <basicUdiDi>69444138MT805SNV</basicUdiDi>
    <tradeName>Trolley (for medical use)</tradeName>
    <deviceName>Trolley (for medical use)</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>Z11049080</emdnCode>
    <emdnDescription>VARIOUS ULTRASOUND INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MT-818</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:36:12.696Z</lastUpdated>
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    <udiDi>06944413835214</udiDi>
    <basicUdiDi>69444138iT30SYS</basicUdiDi>
    <tradeName>Telemetry Monitor</tradeName>
    <deviceName>Telemetry 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>iT50</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:36:10.220Z</lastUpdated>
  </row>
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    <udiDi>06944413835153</udiDi>
    <basicUdiDi>69444138iT30SYS</basicUdiDi>
    <tradeName>Telemetry Monitor</tradeName>
    <deviceName>Telemetry 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>iT30</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:36:06.618Z</lastUpdated>
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    <udiDi>06944413834774</udiDi>
    <basicUdiDi>69444138isafeCsCD</basicUdiDi>
    <tradeName>Blood Sampler</tradeName>
    <deviceName>Blood Sampler</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 Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0501010203</emdnCode>
    <emdnDescription>BLOOD COLLECTION, CAPILLARY TUBES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>isafeC-100BN</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:36:04.217Z</lastUpdated>
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    <udiDi>06944413834767</udiDi>
    <basicUdiDi>69444138isafeCsCD</basicUdiDi>
    <tradeName>Blood Sampler</tradeName>
    <deviceName>Blood Sampler</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 Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0501010203</emdnCode>
    <emdnDescription>BLOOD COLLECTION, CAPILLARY TUBES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>isafeC-85AN</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:36:03.192Z</lastUpdated>
  </row>
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    <udiDi>06944413834750</udiDi>
    <basicUdiDi>69444138isafeCsCD</basicUdiDi>
    <tradeName>Blood Sampler</tradeName>
    <deviceName>Blood Sampler</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 Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0501010203</emdnCode>
    <emdnDescription>BLOOD COLLECTION, CAPILLARY TUBES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>isafeC-115BY</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:36:00.613Z</lastUpdated>
  </row>
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    <udiDi>06944413834743</udiDi>
    <basicUdiDi>69444138isafeCsCD</basicUdiDi>
    <tradeName>Blood Sampler</tradeName>
    <deviceName>Blood Sampler</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 Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0501010203</emdnCode>
    <emdnDescription>BLOOD COLLECTION, CAPILLARY TUBES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>isafeC-100AY</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:35:55.846Z</lastUpdated>
  </row>
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    <udiDi>06944413834736</udiDi>
    <basicUdiDi>69444138SKS5Q</basicUdiDi>
    <tradeName>EMG/Stimulation sensor</tradeName>
    <deviceName>EMG/Stimulation sensor</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>U070399</emdnCode>
    <emdnDescription>PELVIC FLOOR REHABILITATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SK5050WF-F</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:35:53.407Z</lastUpdated>
  </row>
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    <udiDi>06944413834415</udiDi>
    <basicUdiDi>69444138iV12SZ4</basicUdiDi>
    <tradeName>Patient Monitor</tradeName>
    <deviceName>Patient 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>Z1203020201</emdnCode>
    <emdnDescription>MULTI–PARAMETER PATIENT BEDSIDE MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>iV17</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:35:52.203Z</lastUpdated>
  </row>
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    <udiDi>06944413834200</udiDi>
    <basicUdiDi>69444138ConCableBK</basicUdiDi>
    <tradeName>Connection Cable</tradeName>
    <deviceName>Connection 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>Z12030280</emdnCode>
    <emdnDescription>VITAL SIGNS MONITORING INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01.57.472024</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:35:48.598Z</lastUpdated>
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