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    <tradeName>NIBP Cuff</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Contec Medical Systems Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000007715</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12040180</emdnCode>
    <emdnDescription>GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IGN0081</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:08:57.033Z</lastUpdated>
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    <udiDi>06945040108610</udiDi>
    <basicUdiDi>69450401IGNYH</basicUdiDi>
    <tradeName>NIBP Cuff</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Contec Medical Systems Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000007715</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12040180</emdnCode>
    <emdnDescription>GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IGN0083</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:08:57.004Z</lastUpdated>
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    <udiDi>06945040108627</udiDi>
    <basicUdiDi>69450401IGNYH</basicUdiDi>
    <tradeName>NIBP Cuff</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Contec Medical Systems Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000007715</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12040180</emdnCode>
    <emdnDescription>GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IGN0098</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:08:56.977Z</lastUpdated>
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    <udiDi>06945040108634</udiDi>
    <basicUdiDi>69450401IGNYH</basicUdiDi>
    <tradeName>NIBP Cuff</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Contec Medical Systems Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000007715</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12040180</emdnCode>
    <emdnDescription>GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IGN0046</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:08:56.950Z</lastUpdated>
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  <row>
    <udiDi>06945040109136</udiDi>
    <basicUdiDi>69450401IGNYH</basicUdiDi>
    <tradeName>NIBP Cuff</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Contec Medical Systems Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000007715</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12040180</emdnCode>
    <emdnDescription>GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IGN0067</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:08:56.788Z</lastUpdated>
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  <row>
    <udiDi>06945040109143</udiDi>
    <basicUdiDi>69450401IGNYH</basicUdiDi>
    <tradeName>NIBP Cuff</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Contec Medical Systems Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000007715</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12040180</emdnCode>
    <emdnDescription>GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IGN0076</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:08:56.764Z</lastUpdated>
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  <row>
    <udiDi>06945040109150</udiDi>
    <basicUdiDi>69450401IGNYH</basicUdiDi>
    <tradeName>NIBP Cuff</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Contec Medical Systems Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000007715</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12040180</emdnCode>
    <emdnDescription>GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IGN0099</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:08:56.741Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945040109167</udiDi>
    <basicUdiDi>69450401IGNYH</basicUdiDi>
    <tradeName>NIBP Cuff</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Contec Medical Systems Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000007715</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12040180</emdnCode>
    <emdnDescription>GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IGN0101</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:08:56.716Z</lastUpdated>
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  <row>
    <udiDi>06945040109174</udiDi>
    <basicUdiDi>69450401IGNYH</basicUdiDi>
    <tradeName>NIBP Cuff</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Contec Medical Systems Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000007715</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12040180</emdnCode>
    <emdnDescription>GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IGN0077</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:08:25.841Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945040109181</udiDi>
    <basicUdiDi>69450401IGNYH</basicUdiDi>
    <tradeName>NIBP Cuff</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Contec Medical Systems Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000007715</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12040180</emdnCode>
    <emdnDescription>GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IGN0084</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:08:25.813Z</lastUpdated>
  </row>
  <row>
    <udiDi>04048675663607</udiDi>
    <basicUdiDi>B-04048675663607</basicUdiDi>
    <tradeName>MPW software version 1.2</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Drägerwerk AG &amp; Co. KGaA</manufacturerName>
    <manufacturerSrn>DE-MF-000005329</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12040192</emdnCode>
    <emdnDescription>GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>MS90107</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:03:04.919Z</lastUpdated>
  </row>
  <row>
    <udiDi>04015630888139</udiDi>
    <basicUdiDi>B-04015630888139</basicUdiDi>
    <tradeName>Accu-Chek Insight</tradeName>
    <deviceName>Accu-Chek Insight Meter mmol/L Replacement Kit</deviceName>
    <manufacturerName>Roche Diabetes Care GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006276</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>Z1204011502</emdnCode>
    <emdnDescription>INVASIVE BLOOD SUGAR MONITORING SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>07249241001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T19:42:27.172Z</lastUpdated>
  </row>
  <row>
    <udiDi>04015630083435</udiDi>
    <basicUdiDi>B-04015630083435</basicUdiDi>
    <tradeName>Accu-Chek Instant</tradeName>
    <deviceName>ACCU-CHEK INSTANT MMOL/L SC SET</deviceName>
    <manufacturerName>Roche Diabetes Care GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006276</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>Z1204011502</emdnCode>
    <emdnDescription>INVASIVE BLOOD SUGAR MONITORING SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09221808054</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T19:42:24.771Z</lastUpdated>
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  <row>
    <udiDi>04015630083428</udiDi>
    <basicUdiDi>B-04015630083428</basicUdiDi>
    <tradeName>Accu-Chek Instant</tradeName>
    <deviceName>ACCU-CHEK INSTANT MMOL/L KIT</deviceName>
    <manufacturerName>Roche Diabetes Care GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006276</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>Z1204011502</emdnCode>
    <emdnDescription>INVASIVE BLOOD SUGAR MONITORING SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09221786041</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T19:42:22.352Z</lastUpdated>
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  <row>
    <udiDi>04015630070732</udiDi>
    <basicUdiDi>B-04015630070732</basicUdiDi>
    <tradeName>Accu-Chek</tradeName>
    <deviceName>Accu-Chek Guide Kit mmol/L FC</deviceName>
    <manufacturerName>Roche Diabetes Care GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006276</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>Z1204011502</emdnCode>
    <emdnDescription>INVASIVE BLOOD SUGAR MONITORING SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>07400918057</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T19:42:19.956Z</lastUpdated>
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  <row>
    <udiDi>04015630066445</udiDi>
    <basicUdiDi>B-04015630066445</basicUdiDi>
    <tradeName>Accu-Chek Mobile</tradeName>
    <deviceName>ACCU-CHEK Mobile Kit HCP mmol/l</deviceName>
    <manufacturerName>Roche Diabetes Care GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006276</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>Z1204011502</emdnCode>
    <emdnDescription>INVASIVE BLOOD SUGAR MONITORING SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>06383602028</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T19:42:18.350Z</lastUpdated>
  </row>
  <row>
    <udiDi>04015630063505</udiDi>
    <basicUdiDi>B-04015630063505</basicUdiDi>
    <tradeName>Accu-Chek Aviva</tradeName>
    <deviceName>Accu-Chek Aviva [Model NC] mmol/L Kit</deviceName>
    <manufacturerName>Roche Diabetes Care GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006276</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>Z1204011502</emdnCode>
    <emdnDescription>INVASIVE BLOOD SUGAR MONITORING SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>06988709170</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T19:42:15.968Z</lastUpdated>
  </row>
  <row>
    <udiDi>04015630063161</udiDi>
    <basicUdiDi>B-04015630063161</basicUdiDi>
    <tradeName>Accu-Chek Mobile</tradeName>
    <deviceName>Accu-Chek Mobile LCM mmol/l HCP</deviceName>
    <manufacturerName>Roche Diabetes Care GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006276</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>Z1204011502</emdnCode>
    <emdnDescription>INVASIVE BLOOD SUGAR MONITORING SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>06383602057</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T19:42:14.357Z</lastUpdated>
  </row>
  <row>
    <udiDi>03830088640013</udiDi>
    <basicUdiDi>B-03830088640013</basicUdiDi>
    <tradeName>Vitaly Questionnaires</tradeName>
    <deviceName>Vitaly Questionnaires</deviceName>
    <manufacturerName>Open Line Vitaly d.o.o.</manufacturerName>
    <manufacturerSrn>SI-MF-000002597</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12040192</emdnCode>
    <emdnDescription>GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1.0.0.</reference>
    <placedOnMarketCountry>Slovenia</placedOnMarketCountry>
    <lastUpdated>2026-07-05T19:36:59.456Z</lastUpdated>
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    <udiDi>03770033945001</udiDi>
    <basicUdiDi>B-03770033945001</basicUdiDi>
    <tradeName>CONTINUUM + CONNECT</tradeName>
    <deviceName>CONTINUUM + ALERT MODULE</deviceName>
    <manufacturerName>CONTINUUM PLUS SANTE</manufacturerName>
    <manufacturerSrn>FR-MF-000020646</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12040192</emdnCode>
    <emdnDescription>GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ALERT MODULE</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T19:36:13.032Z</lastUpdated>
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