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<eudamedExport entity="devices">
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    <udiDi>00385640000581</udiDi>
    <basicUdiDi>B-00385640000581</basicUdiDi>
    <tradeName>Shepard, SI, 1.00 mm</tradeName>
    <deviceName>Otological Ventilation Tubes</deviceName>
    <manufacturerName>Summit Medical, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000026771</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q03040199</emdnCode>
    <emdnDescription>EAR DRAINAGE AND VENTILATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VT-0200-01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T06:56:16.920Z</lastUpdated>
  </row>
  <row>
    <udiDi>00385640000567</udiDi>
    <basicUdiDi>B-00385640000567</basicUdiDi>
    <tradeName>Donaldson, FP, 1.14mm</tradeName>
    <deviceName>Otological Ventilation Tubes</deviceName>
    <manufacturerName>Summit Medical, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000026771</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q03040199</emdnCode>
    <emdnDescription>EAR DRAINAGE AND VENTILATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VT-0102-01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T06:56:16.121Z</lastUpdated>
  </row>
  <row>
    <udiDi>00385640000543</udiDi>
    <basicUdiDi>B-00385640000543</basicUdiDi>
    <tradeName>Donaldson, SI, 1.14 mm</tradeName>
    <deviceName>Otological Ventilation Tubes</deviceName>
    <manufacturerName>Summit Medical, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000026771</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q03040199</emdnCode>
    <emdnDescription>EAR DRAINAGE AND VENTILATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VT-0101-01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T06:56:12.126Z</lastUpdated>
  </row>
  <row>
    <udiDi>00385640000505</udiDi>
    <basicUdiDi>B-00385640000505</basicUdiDi>
    <tradeName>Donaldson, SI 1.14mm</tradeName>
    <deviceName>Otological Ventilation Tubes</deviceName>
    <manufacturerName>Summit Medical, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000026771</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q03040199</emdnCode>
    <emdnDescription>EAR DRAINAGE AND VENTILATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VT-0100-01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T06:56:11.347Z</lastUpdated>
  </row>
  <row>
    <udiDi>17290013496345</udiDi>
    <basicUdiDi>7290013496OTIKONEARDROP4Y</basicUdiDi>
    <tradeName>OLIVE OIL-BASED EAR DROPS (15ml spray bottle)</tradeName>
    <deviceName>Olive Oil-Based Ear Drops</deviceName>
    <manufacturerName>Tree of Life Pharma Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000010023</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q030499</emdnCode>
    <emdnDescription>OTOLOGY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>301</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-08-01T02:47:10.217Z</lastUpdated>
  </row>
  <row>
    <udiDi>++G565PSTSKV</udiDi>
    <basicUdiDi>B-++G565PSTSKV</basicUdiDi>
    <tradeName>Mouth &amp; Throat Spray with Propionate</tradeName>
    <deviceName>Proponent Solutions - Throat Spray</deviceName>
    <manufacturerName>PROPONENT Biotech AG</manufacturerName>
    <manufacturerSrn>CH-MF-000036207</manufacturerSrn>
    <authorisedRepresentativeName>Ursatec GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000035691</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q0399</emdnCode>
    <emdnDescription>ENT DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PSTS01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T22:48:15.294Z</lastUpdated>
  </row>
  <row>
    <udiDi>++G565PSNSKB</udiDi>
    <basicUdiDi>B-++G565PSNSKB</basicUdiDi>
    <tradeName>Proponent Nesespray</tradeName>
    <deviceName>Proponent Solutions - Nasal Spray</deviceName>
    <manufacturerName>PROPONENT Biotech AG</manufacturerName>
    <manufacturerSrn>CH-MF-000036207</manufacturerSrn>
    <authorisedRepresentativeName>Ursatec GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000035691</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q030103</emdnCode>
    <emdnDescription>NASAL IRRIGATION SOLUTIONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PSNS02</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-31T22:48:13.690Z</lastUpdated>
  </row>
  <row>
    <udiDi>++G565PSESJG</udiDi>
    <basicUdiDi>B-++G565PSESJG</basicUdiDi>
    <tradeName>Ear Spray with Propionate</tradeName>
    <deviceName>Proponent Solutions - Ear Spray</deviceName>
    <manufacturerName>PROPONENT Biotech AG</manufacturerName>
    <manufacturerSrn>CH-MF-000036207</manufacturerSrn>
    <authorisedRepresentativeName>Ursatec GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000035691</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q03040299</emdnCode>
    <emdnDescription>EAR IRRIGATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PSES01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T22:48:11.289Z</lastUpdated>
  </row>
  <row>
    <udiDi>08906167530294</udiDi>
    <basicUdiDi>890616753SEDRZ</basicUdiDi>
    <tradeName>Swimmer's Ear Drops</tradeName>
    <deviceName>Swimmer's Ear Drops</deviceName>
    <manufacturerName>Zuche Pharmaceuticals Pvt Ltd</manufacturerName>
    <manufacturerSrn>IN-MF-000010593</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q030499</emdnCode>
    <emdnDescription>OTOLOGY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SED</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-31T21:28:08.511Z</lastUpdated>
  </row>
  <row>
    <udiDi>08906167530270</udiDi>
    <basicUdiDi>890616753SBSSN</basicUdiDi>
    <tradeName>Otaspray (Sodium Bicarbonate Ear Spray)</tradeName>
    <deviceName>Sodium Bicarbonate Ear Spray</deviceName>
    <manufacturerName>Zuche Pharmaceuticals Pvt Ltd</manufacturerName>
    <manufacturerSrn>IN-MF-000010593</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q03040299</emdnCode>
    <emdnDescription>EAR IRRIGATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SBS</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T21:28:04.276Z</lastUpdated>
  </row>
  <row>
    <udiDi>08906167530263</udiDi>
    <basicUdiDi>890616753OLSSY</basicUdiDi>
    <tradeName>Otowax (Olive Oil Ear Spray)</tradeName>
    <deviceName>Olive Oil Ear Spray</deviceName>
    <manufacturerName>Zuche Pharmaceuticals Pvt Ltd</manufacturerName>
    <manufacturerSrn>IN-MF-000010593</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q03040299</emdnCode>
    <emdnDescription>EAR IRRIGATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OLS</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T21:28:03.611Z</lastUpdated>
  </row>
  <row>
    <udiDi>08906167530119</udiDi>
    <basicUdiDi>890616753OLDS2</basicUdiDi>
    <tradeName>Otadrop</tradeName>
    <deviceName>Olive Oil Ear Drops</deviceName>
    <manufacturerName>Zuche Pharmaceuticals Pvt Ltd</manufacturerName>
    <manufacturerSrn>IN-MF-000010593</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q03040299</emdnCode>
    <emdnDescription>EAR IRRIGATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OLD</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T21:28:00.226Z</lastUpdated>
  </row>
  <row>
    <udiDi>08906167530041</udiDi>
    <basicUdiDi>890616753SBDRQ</basicUdiDi>
    <tradeName>ClearEar Extra (Sodium Bicarbonate Ear Drops)</tradeName>
    <deviceName>Sodium Bicarbonate Ear Drops</deviceName>
    <manufacturerName>Zuche Pharmaceuticals Pvt Ltd</manufacturerName>
    <manufacturerSrn>IN-MF-000010593</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q03040299</emdnCode>
    <emdnDescription>EAR IRRIGATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SBD</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T21:27:57.334Z</lastUpdated>
  </row>
  <row>
    <udiDi>08906039318081</udiDi>
    <basicUdiDi>89044287ESFM</basicUdiDi>
    <tradeName>Osseous</tradeName>
    <deviceName>Ear Specula</deviceName>
    <manufacturerName>EON MEDITECH PVT. LTD</manufacturerName>
    <manufacturerSrn>IN-MF-000014457</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q030499</emdnCode>
    <emdnDescription>OTOLOGY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EI0951</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-31T21:14:00.309Z</lastUpdated>
  </row>
  <row>
    <udiDi>08903175089240</udiDi>
    <basicUdiDi>8903175PSLMYKA2</basicUdiDi>
    <tradeName>Paramount</tradeName>
    <deviceName>Myringotomy Knives</deviceName>
    <manufacturerName>Paramount Surgimed Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000021682</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q030301</emdnCode>
    <emdnDescription>ENT SURGERY BLADES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PSSML</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T21:13:06.633Z</lastUpdated>
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    <udiDi>18800029902533</udiDi>
    <basicUdiDi>88000299GTUTL20WB</basicUdiDi>
    <tradeName>ENT UNIT</tradeName>
    <deviceName>ENT UNIT</deviceName>
    <manufacturerName>Mega Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000008718</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0399</emdnCode>
    <emdnDescription>ENT DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NET-4000 / MGSI-CA-ENT UNIT</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-31T21:04:23.386Z</lastUpdated>
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    <udiDi>18800029902502</udiDi>
    <basicUdiDi>88000299GTVS10PP</basicUdiDi>
    <tradeName>18800029902502</tradeName>
    <deviceName>ENT Endoscopy Visual System</deviceName>
    <manufacturerName>Mega Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000008718</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0399</emdnCode>
    <emdnDescription>ENT DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ENT Endoscopy Visual System / MGSI-CA-260SLCB</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-31T21:04:19.388Z</lastUpdated>
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    <udiDi>18800029902496</udiDi>
    <basicUdiDi>88000299GTCA10GQ</basicUdiDi>
    <tradeName>ENT Chair</tradeName>
    <deviceName>ENT Chair</deviceName>
    <manufacturerName>Mega Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000008718</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0399</emdnCode>
    <emdnDescription>ENT DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NET-1500D / MGSI-CA-ENT UNIT</reference>
    <placedOnMarketCountry>Lithuania</placedOnMarketCountry>
    <lastUpdated>2026-07-31T21:04:18.574Z</lastUpdated>
  </row>
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    <udiDi>18800029902489</udiDi>
    <basicUdiDi>88000299GTUTM20WG</basicUdiDi>
    <tradeName>ENT UNIT</tradeName>
    <deviceName>ENT UNIT</deviceName>
    <manufacturerName>Mega Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000008718</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0399</emdnCode>
    <emdnDescription>ENT DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NET-600A / MGSI-CA-ENT UNIT</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-31T21:04:17.766Z</lastUpdated>
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    <udiDi>18800029902472</udiDi>
    <basicUdiDi>88000299GTUT20PQ</basicUdiDi>
    <tradeName>ENT UNIT</tradeName>
    <deviceName>ENT UNIT</deviceName>
    <manufacturerName>Mega Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000008718</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0399</emdnCode>
    <emdnDescription>ENT DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NET-1100 / MGSI-CA-ENT UNIT</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-31T21:04:16.971Z</lastUpdated>
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