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    <tradeName>Sanibel Button electrode cable</tradeName>
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    <manufacturerName>DGS Diagnostics A/S</manufacturerName>
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    <basicUdiDi>5711117_P-0000508_RS</basicUdiDi>
    <tradeName>Sanibel Button electrode cable</tradeName>
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    <tradeName>Sanibel Button electrode cable</tradeName>
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    <manufacturerName>DGS Diagnostics A/S</manufacturerName>
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    <tradeName>Set Cribado Neonatal Clip 20</tradeName>
    <deviceName>Agrupaciones Cribado ORL</deviceName>
    <manufacturerName>PRIM, S.A.</manufacturerName>
    <manufacturerSrn>ES-PR-000004648</manufacturerSrn>
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    <reference>PM0101C</reference>
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    <lastUpdated>2026-07-03T10:37:02.563Z</lastUpdated>
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    <basicUdiDi>805418738EP1LDY</basicUdiDi>
    <tradeName>AEP Basic license</tradeName>
    <deviceName>Celesta License</deviceName>
    <manufacturerName>INVENTIS S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000012495</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
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    <emdnCode>Z12140382</emdnCode>
    <emdnDescription>EVOKED POTENTIAL AUDIOMETRY INSTRUMENTS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>12381</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
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    <basicUdiDi>805418738EP1KK</basicUdiDi>
    <tradeName>Celesta</tradeName>
    <deviceName>Celesta</deviceName>
    <manufacturerName>INVENTIS S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000012495</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnCode>Z12140302</emdnCode>
    <emdnDescription>EVOKED POTENTIAL AUDIOMETRY EQUIPMENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <udiDi>07350170210000</udiDi>
    <basicUdiDi>735017021SensoDetectZA</basicUdiDi>
    <tradeName>SensoDetect® BERA System</tradeName>
    <deviceName>SensoDetect® BERA System</deviceName>
    <manufacturerName>Sensodetect AB</manufacturerName>
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    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>A1000-4</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:08:37.236Z</lastUpdated>
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    <tradeName>Aurality</tradeName>
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    <manufacturerName>Ahead of Health AS</manufacturerName>
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    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>MDR 2017/745</legislation>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>HT1</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-02T22:17:18.060Z</lastUpdated>
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    <basicUdiDi>5711117_P-0000556_02_YN</basicUdiDi>
    <tradeName>Sanibel EARturtle Universal Box of 36 kits w/tab electrodes</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DGS Diagnostics A/S</manufacturerName>
    <manufacturerSrn>DK-PR-000031217</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12140385</emdnCode>
    <emdnDescription>EVOKED POTENTIAL AUDIOMETRY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8537209</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T01:47:40.854Z</lastUpdated>
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    <udiDi>05711117230796</udiDi>
    <basicUdiDi>5711117_P-0000403_R4</basicUdiDi>
    <tradeName>Sanibel EARturtle Universal</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DGS Diagnostics A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000020570</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12140385</emdnCode>
    <emdnDescription>EVOKED POTENTIAL AUDIOMETRY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8537206</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-02T01:47:40.141Z</lastUpdated>
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    <udiDi>08054187381225</udiDi>
    <basicUdiDi>805418738EP1KK</basicUdiDi>
    <tradeName>Celesta (IP)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>INVENTIS S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000012495</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12140302</emdnCode>
    <emdnDescription>EVOKED POTENTIAL AUDIOMETRY EQUIPMENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>12380-IP</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T19:42:59.779Z</lastUpdated>
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    <udiDi>08054187381201</udiDi>
    <basicUdiDi>805418738EP1LDY</basicUdiDi>
    <tradeName>AEP Plus license</tradeName>
    <deviceName></deviceName>
    <manufacturerName>INVENTIS S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000012495</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12140382</emdnCode>
    <emdnDescription>EVOKED POTENTIAL AUDIOMETRY INSTRUMENTS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>12382</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T19:42:50.280Z</lastUpdated>
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    <udiDi>08054187381218</udiDi>
    <basicUdiDi>805418738EP1LDY</basicUdiDi>
    <tradeName>VEMP license</tradeName>
    <deviceName></deviceName>
    <manufacturerName>INVENTIS S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000012495</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>MDR 2017/745</legislation>
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    <emdnDescription>EVOKED POTENTIAL AUDIOMETRY INSTRUMENTS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>12383</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T19:42:50.057Z</lastUpdated>
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    <tradeName>Sanibel EARturtle Universal Box of 36 kits w/snap electrodes</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DGS Diagnostics A/S</manufacturerName>
    <manufacturerSrn>DK-PR-000031217</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
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    <emdnCode>Z12140385</emdnCode>
    <emdnDescription>EVOKED POTENTIAL AUDIOMETRY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8602500</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T22:41:11.756Z</lastUpdated>
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    <basicUdiDi>0426022Probes-2aTM</basicUdiDi>
    <tradeName>PT-S</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PATH MEDICAL GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006935</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12140380</emdnCode>
    <emdnDescription>OTOACOUSTIC EMISSIONS EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100014</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T10:45:15.857Z</lastUpdated>
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    <tradeName>Accessory Box Sentiero</tradeName>
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    <manufacturerName>PATH MEDICAL GmbH</manufacturerName>
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    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnCode>Z12140380</emdnCode>
    <emdnDescription>OTOACOUSTIC EMISSIONS EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100135</reference>
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    <lastUpdated>2026-06-20T10:45:15.834Z</lastUpdated>
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    <deviceName></deviceName>
    <manufacturerName>PATH MEDICAL GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006935</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnCode>Z12140380</emdnCode>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>100207</reference>
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    <lastUpdated>2026-06-20T10:45:15.808Z</lastUpdated>
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    <tradeName>Accessory Box</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PATH MEDICAL GmbH</manufacturerName>
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    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnCode>Z12140380</emdnCode>
    <emdnDescription>OTOACOUSTIC EMISSIONS EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100261</reference>
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    <deviceName></deviceName>
    <manufacturerName>PATH MEDICAL GmbH</manufacturerName>
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    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnCode>Z12140380</emdnCode>
    <emdnDescription>OTOACOUSTIC EMISSIONS EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry></placedOnMarketCountry>
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    <deviceName></deviceName>
    <manufacturerName>PATH MEDICAL GmbH</manufacturerName>
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    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12140380</emdnCode>
    <emdnDescription>OTOACOUSTIC EMISSIONS EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100263</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T10:45:15.572Z</lastUpdated>
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