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<eudamedExport entity="devices">
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    <udiDi>08906194162208</udiDi>
    <basicUdiDi>890619416NTISQ2</basicUdiDi>
    <tradeName>ClearSheath</tradeName>
    <deviceName>Introducer Sheath with Dilator</deviceName>
    <manufacturerName>Newtech Medical Devices Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000045809</manufacturerSrn>
    <authorisedRepresentativeName>Amstermed B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001971</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C0502</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, VALVED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NT/IS/FSM/0407</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:53:45.122Z</lastUpdated>
  </row>
  <row>
    <udiDi>08906194160273</udiDi>
    <basicUdiDi>890619416NTCSPG</basicUdiDi>
    <tradeName>ClearSyringe</tradeName>
    <deviceName>Control Syringe</deviceName>
    <manufacturerName>Newtech Medical Devices Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000045809</manufacturerSrn>
    <authorisedRepresentativeName>Amstermed B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001971</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A020102020102</emdnCode>
    <emdnDescription>INFUSION AND IRRIGATION SYRINGES, LUER LOCK CONE, 3-PIECE WITHOUT NEEDLE, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NT/CS/10ML</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:53:41.130Z</lastUpdated>
  </row>
  <row>
    <udiDi>08906194160259</udiDi>
    <basicUdiDi>890619416NTRABNT</basicUdiDi>
    <tradeName>ClearBand</tradeName>
    <deviceName>Radial Artery Band</deviceName>
    <manufacturerName>Newtech Medical Devices Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000045809</manufacturerSrn>
    <authorisedRepresentativeName>Amstermed B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001971</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C010402020180</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NT/RAB/01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:53:40.400Z</lastUpdated>
  </row>
  <row>
    <udiDi>08906194160174</udiDi>
    <basicUdiDi>890619416NTIDP4</basicUdiDi>
    <tradeName>ClearID</tradeName>
    <deviceName>Inflation device</deviceName>
    <manufacturerName>Newtech Medical Devices Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000045809</manufacturerSrn>
    <authorisedRepresentativeName>Amstermed B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001971</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C010402020180</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NT/ID/012</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:53:39.547Z</lastUpdated>
  </row>
  <row>
    <udiDi>08906194160020</udiDi>
    <basicUdiDi>890619416NTMANNS</basicUdiDi>
    <tradeName>ClearFold</tradeName>
    <deviceName>Manifold</deviceName>
    <manufacturerName>Newtech Medical Devices Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000045809</manufacturerSrn>
    <authorisedRepresentativeName>Amstermed B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001971</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A0703</emdnCode>
    <emdnDescription>STOPCOCKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NT/MAN/3ONP</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:53:38.716Z</lastUpdated>
  </row>
  <row>
    <udiDi>08906194162239</udiDi>
    <basicUdiDi>890619416NTISQ2</basicUdiDi>
    <tradeName>08906194162239</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Newtech Medical Devices Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000045809</manufacturerSrn>
    <authorisedRepresentativeName>Amstermed B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001971</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C0502</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, VALVED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-03T00:28:20.810Z</lastUpdated>
  </row>
  <row>
    <udiDi>08906194160280</udiDi>
    <basicUdiDi>890619416NTCSPG</basicUdiDi>
    <tradeName>ClearSyringe</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Newtech Medical Devices Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000045809</manufacturerSrn>
    <authorisedRepresentativeName>Amstermed B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001971</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A020102020102</emdnCode>
    <emdnDescription>INFUSION AND IRRIGATION SYRINGES, LUER LOCK CONE, 3-PIECE WITHOUT NEEDLE, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-27T03:45:27.032Z</lastUpdated>
  </row>
  <row>
    <udiDi>08906194160297</udiDi>
    <basicUdiDi>890619416NTCSPG</basicUdiDi>
    <tradeName>ClearSyringe</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Newtech Medical Devices Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000045809</manufacturerSrn>
    <authorisedRepresentativeName>Amstermed B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001971</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A020102020102</emdnCode>
    <emdnDescription>INFUSION AND IRRIGATION SYRINGES, LUER LOCK CONE, 3-PIECE WITHOUT NEEDLE, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-27T03:45:27.010Z</lastUpdated>
  </row>
  <row>
    <udiDi>08906194162215</udiDi>
    <basicUdiDi>890619416NTISQ2</basicUdiDi>
    <tradeName>ClearSheath</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Newtech Medical Devices Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000045809</manufacturerSrn>
    <authorisedRepresentativeName>Amstermed B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001971</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C0502</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, VALVED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-27T03:45:26.913Z</lastUpdated>
  </row>
  <row>
    <udiDi>08906194162222</udiDi>
    <basicUdiDi>890619416NTISQ2</basicUdiDi>
    <tradeName>ClearSheath</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Newtech Medical Devices Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000045809</manufacturerSrn>
    <authorisedRepresentativeName>Amstermed B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001971</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C0502</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, VALVED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-27T03:45:26.886Z</lastUpdated>
  </row>
  <row>
    <udiDi>08906194162246</udiDi>
    <basicUdiDi>890619416NTISQ2</basicUdiDi>
    <tradeName>ClearSheath</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Newtech Medical Devices Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000045809</manufacturerSrn>
    <authorisedRepresentativeName>Amstermed B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001971</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C0502</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, VALVED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-27T03:45:26.866Z</lastUpdated>
  </row>
  <row>
    <udiDi>08906194162253</udiDi>
    <basicUdiDi>890619416NTISQ2</basicUdiDi>
    <tradeName>ClearSheath</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Newtech Medical Devices Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000045809</manufacturerSrn>
    <authorisedRepresentativeName>Amstermed B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001971</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C0502</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, VALVED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-27T03:45:26.848Z</lastUpdated>
  </row>
  <row>
    <udiDi>08906194162260</udiDi>
    <basicUdiDi>890619416NTISQ2</basicUdiDi>
    <tradeName>ClearSheath</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Newtech Medical Devices Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000045809</manufacturerSrn>
    <authorisedRepresentativeName>Amstermed B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001971</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C0502</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, VALVED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-27T03:45:26.830Z</lastUpdated>
  </row>
  <row>
    <udiDi>08906194162277</udiDi>
    <basicUdiDi>890619416NTISQ2</basicUdiDi>
    <tradeName>ClearSheath</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Newtech Medical Devices Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000045809</manufacturerSrn>
    <authorisedRepresentativeName>Amstermed B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001971</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C0502</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, VALVED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-27T03:45:26.815Z</lastUpdated>
  </row>
  <row>
    <udiDi>08906194162284</udiDi>
    <basicUdiDi>890619416NTISQ2</basicUdiDi>
    <tradeName>ClearSheath</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Newtech Medical Devices Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000045809</manufacturerSrn>
    <authorisedRepresentativeName>Amstermed B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001971</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C0502</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, VALVED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-27T03:45:26.795Z</lastUpdated>
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    <udiDi>08906194162291</udiDi>
    <basicUdiDi>890619416NTISQ2</basicUdiDi>
    <tradeName>ClearSheath</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Newtech Medical Devices Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000045809</manufacturerSrn>
    <authorisedRepresentativeName>Amstermed B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001971</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C0502</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, VALVED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-27T03:45:26.773Z</lastUpdated>
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    <udiDi>08906194162307</udiDi>
    <basicUdiDi>890619416NTISQ2</basicUdiDi>
    <tradeName>ClearSheath</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Newtech Medical Devices Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000045809</manufacturerSrn>
    <authorisedRepresentativeName>Amstermed B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001971</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C0502</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, VALVED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-27T03:45:26.753Z</lastUpdated>
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  <row>
    <udiDi>08906194162314</udiDi>
    <basicUdiDi>890619416NTISQ2</basicUdiDi>
    <tradeName>ClearSheath</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Newtech Medical Devices Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000045809</manufacturerSrn>
    <authorisedRepresentativeName>Amstermed B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001971</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C0502</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, VALVED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-27T03:45:26.733Z</lastUpdated>
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    <udiDi>08906194162321</udiDi>
    <basicUdiDi>890619416NTISQ2</basicUdiDi>
    <tradeName>ClearSheath</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Newtech Medical Devices Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000045809</manufacturerSrn>
    <authorisedRepresentativeName>Amstermed B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001971</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C0502</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, VALVED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-27T03:45:26.713Z</lastUpdated>
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    <udiDi>08906194162338</udiDi>
    <basicUdiDi>890619416NTISQ2</basicUdiDi>
    <tradeName>ClearSheath</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Newtech Medical Devices Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000045809</manufacturerSrn>
    <authorisedRepresentativeName>Amstermed B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001971</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C0502</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, VALVED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-27T03:45:26.692Z</lastUpdated>
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