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    <manufacturerName>Tianjin Bolang Science-Technology Development Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008431</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
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    <reference>ER03.100</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-27T23:01:03.574Z</lastUpdated>
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    <lastUpdated>2026-06-27T23:01:02.374Z</lastUpdated>
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    <udiDi>06947752802060</udiDi>
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    <deviceName>Otoscope</deviceName>
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    <manufacturerSrn>CN-MF-000008431</manufacturerSrn>
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    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-27T23:00:59.972Z</lastUpdated>
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    <udiDi>06947752802053</udiDi>
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    <tradeName>Otoscope</tradeName>
    <deviceName>Otoscope</deviceName>
    <manufacturerName>Tianjin Bolang Science-Technology Development Co.,Ltd.</manufacturerName>
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    <emdnCode>Z12149006</emdnCode>
    <emdnDescription>DIRECT OUTPATIENT OTOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ER34</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-27T23:00:56.378Z</lastUpdated>
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    <udiDi>06947752802046</udiDi>
    <basicUdiDi>69477528ERJT</basicUdiDi>
    <tradeName>Otoscope</tradeName>
    <deviceName>Otoscope</deviceName>
    <manufacturerName>Tianjin Bolang Science-Technology Development Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008431</manufacturerSrn>
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    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12149006</emdnCode>
    <emdnDescription>DIRECT OUTPATIENT OTOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ER04</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-27T23:00:53.967Z</lastUpdated>
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    <udiDi>06947752802039</udiDi>
    <basicUdiDi>69477528ERJT</basicUdiDi>
    <tradeName>Otoscope</tradeName>
    <deviceName>Otoscope</deviceName>
    <manufacturerName>Tianjin Bolang Science-Technology Development Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008431</manufacturerSrn>
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    <riskClass>Sınıf I</riskClass>
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    <emdnDescription>DIRECT OUTPATIENT OTOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ER33</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-27T23:00:52.765Z</lastUpdated>
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    <udiDi>06947752802022</udiDi>
    <basicUdiDi>69477528ERJT</basicUdiDi>
    <tradeName>Otoscope</tradeName>
    <deviceName>Otoscope</deviceName>
    <manufacturerName>Tianjin Bolang Science-Technology Development Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008431</manufacturerSrn>
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    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12149006</emdnCode>
    <emdnDescription>DIRECT OUTPATIENT OTOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ER03</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-27T23:00:50.363Z</lastUpdated>
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    <udiDi>06947752802015</udiDi>
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    <tradeName>Otoscope</tradeName>
    <deviceName>Otoscope</deviceName>
    <manufacturerName>Tianjin Bolang Science-Technology Development Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008431</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
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    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12149006</emdnCode>
    <emdnDescription>DIRECT OUTPATIENT OTOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ER32</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-27T23:00:45.566Z</lastUpdated>
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    <udiDi>06947752802008</udiDi>
    <basicUdiDi>69477528ERJT</basicUdiDi>
    <tradeName>Otoscope</tradeName>
    <deviceName>Otoscope</deviceName>
    <manufacturerName>Tianjin Bolang Science-Technology Development Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008431</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12149006</emdnCode>
    <emdnDescription>DIRECT OUTPATIENT OTOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ER02</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-27T23:00:43.182Z</lastUpdated>
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    <udiDi>06945095544913</udiDi>
    <basicUdiDi>69450955otoscopeTK</basicUdiDi>
    <tradeName>OT8K</tradeName>
    <deviceName>otoscope</deviceName>
    <manufacturerName>Zumax Medical CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000011126</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12149006</emdnCode>
    <emdnDescription>DIRECT OUTPATIENT OTOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>462-1110</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T15:53:36.238Z</lastUpdated>
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    <udiDi>06945095544180</udiDi>
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    <deviceName>otoscope</deviceName>
    <manufacturerName>Zumax Medical CO., LTD.</manufacturerName>
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    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12149006</emdnCode>
    <emdnDescription>DIRECT OUTPATIENT OTOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>462-1810</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T15:50:44.554Z</lastUpdated>
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    <udiDi>06945095543909</udiDi>
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    <deviceName>otoscope</deviceName>
    <manufacturerName>Zumax Medical CO., LTD.</manufacturerName>
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    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12149006</emdnCode>
    <emdnDescription>DIRECT OUTPATIENT OTOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>468-1110</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T15:49:42.118Z</lastUpdated>
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    <udiDi>04035873063803</udiDi>
    <basicUdiDi>4035873120101029S</basicUdiDi>
    <tradeName>OTOSCOPES</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Henke-Sass, Wolf GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005531</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12149006</emdnCode>
    <emdnDescription>DIRECT OUTPATIENT OTOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>89550239</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T04:11:38.242Z</lastUpdated>
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    <udiDi>04035873063810</udiDi>
    <basicUdiDi>4035873120101029S</basicUdiDi>
    <tradeName>OTOSCOPES</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Henke-Sass, Wolf GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005531</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12149006</emdnCode>
    <emdnDescription>DIRECT OUTPATIENT OTOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>89550241</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T04:11:38.217Z</lastUpdated>
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    <basicUdiDi>4035873120101029S</basicUdiDi>
    <tradeName>OTOSCOPES</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Henke-Sass, Wolf GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005531</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12149006</emdnCode>
    <emdnDescription>DIRECT OUTPATIENT OTOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>89550242</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T04:11:38.202Z</lastUpdated>
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    <udiDi>04035873063834</udiDi>
    <basicUdiDi>4035873120101029S</basicUdiDi>
    <tradeName>OTOSCOPES</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Henke-Sass, Wolf GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005531</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12149006</emdnCode>
    <emdnDescription>DIRECT OUTPATIENT OTOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>89550243</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T04:11:38.178Z</lastUpdated>
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    <tradeName>04260381960027</tradeName>
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    <manufacturerName>Luxamed GmbH &amp; Co. KG</manufacturerName>
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    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12149006</emdnCode>
    <emdnDescription>DIRECT OUTPATIENT OTOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A1.416.214</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:54:48.005Z</lastUpdated>
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    <manufacturerName>Luxamed GmbH &amp; Co. KG</manufacturerName>
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    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12149006</emdnCode>
    <emdnDescription>DIRECT OUTPATIENT OTOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A1.416.314</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:54:47.979Z</lastUpdated>
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    <deviceName></deviceName>
    <manufacturerName>Luxamed GmbH &amp; Co. KG</manufacturerName>
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    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12149006</emdnCode>
    <emdnDescription>DIRECT OUTPATIENT OTOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A1.426.114</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:54:47.954Z</lastUpdated>
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    <deviceName></deviceName>
    <manufacturerName>Luxamed GmbH &amp; Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000006437</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12149006</emdnCode>
    <emdnDescription>DIRECT OUTPATIENT OTOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A1.426.214</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:54:47.925Z</lastUpdated>
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