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    <manufacturerName>Firefly Global</manufacturerName>
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    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
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    <legislation>MDR 2017/745</legislation>
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    <reference>DE500</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:33:56.881Z</lastUpdated>
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    <basicUdiDi>0851289007DE550QQ</basicUdiDi>
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    <manufacturerName>Firefly Global</manufacturerName>
    <manufacturerSrn>US-MF-000020015</manufacturerSrn>
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    <emdnDescription>DIRECT OUTPATIENT OTOSCOPES</emdnDescription>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
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    <manufacturerName>hearX SA (Pty) Ltd</manufacturerName>
    <manufacturerSrn>ZA-MF-000031452</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
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    <legislation>MDR 2017/745</legislation>
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    <reference>None</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:19:51.068Z</lastUpdated>
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    <deviceName>Bertec Balance Advantage Computerized Dynamic Posturography (CDP) System</deviceName>
    <manufacturerName>Bertec Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000008643</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
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    <emdnDescription>POSTUROGRAPHY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>97P-0036</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:13:30.450Z</lastUpdated>
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    <udiDi>00850017250017</udiDi>
    <basicUdiDi>0850017250TYPE1002K5</basicUdiDi>
    <tradeName>00850017250017</tradeName>
    <deviceName>Bertec Balance Advantage Prime IVR and Static Systems</deviceName>
    <manufacturerName>Bertec Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000008643</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12140404</emdnCode>
    <emdnDescription>POSTUROGRAPHY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Type 1002-06/97P-0077</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:13:29.944Z</lastUpdated>
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    <udiDi>00850017250000</udiDi>
    <basicUdiDi>0850017250TYPE1003K7</basicUdiDi>
    <tradeName>00850017250000</tradeName>
    <deviceName>Bertec Vision Advantage (BVA) System</deviceName>
    <manufacturerName>Bertec Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000008643</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12140401</emdnCode>
    <emdnDescription>VESTIBULAR ASSESSMENT SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>97P-0037</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:13:10.653Z</lastUpdated>
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    <udiDi>00842318190376</udiDi>
    <basicUdiDi>0842318160516UN</basicUdiDi>
    <tradeName>Pro Fit Fitting Software</tradeName>
    <deviceName>Pro Fit Fitting Software</deviceName>
    <manufacturerName>Starkey Laboratories Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000014382</manufacturerSrn>
    <authorisedRepresentativeName>Starkey Laboratories (Germany) GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010831</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12149092</emdnCode>
    <emdnDescription>VARIOUS ENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>60516-000</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T02:19:03.559Z</lastUpdated>
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    <basicUdiDi>0842318160945VH</basicUdiDi>
    <tradeName>My Starkey Mobile App</tradeName>
    <deviceName>My Starkey Mobile App</deviceName>
    <manufacturerName>Starkey Laboratories Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000014382</manufacturerSrn>
    <authorisedRepresentativeName>Starkey Laboratories (Germany) GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010831</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12149092</emdnCode>
    <emdnDescription>VARIOUS ENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>My Starkey</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T02:18:49.951Z</lastUpdated>
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    <tradeName>Thrive Software</tradeName>
    <deviceName>Thrive Software Application</deviceName>
    <manufacturerName>Starkey Laboratories Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000014382</manufacturerSrn>
    <authorisedRepresentativeName>Starkey Laboratories (Germany) GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010831</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12149092</emdnCode>
    <emdnDescription>VARIOUS ENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N/A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T02:18:45.938Z</lastUpdated>
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    <udiDi>00842318117175</udiDi>
    <basicUdiDi>0842318160211TV</basicUdiDi>
    <tradeName>Starkey Inspire X Fitting Software</tradeName>
    <deviceName>Inspire Fitting Software</deviceName>
    <manufacturerName>Starkey Laboratories Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000014382</manufacturerSrn>
    <authorisedRepresentativeName>Starkey Laboratories (Germany) GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010831</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12149092</emdnCode>
    <emdnDescription>VARIOUS ENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>60211</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T02:18:45.140Z</lastUpdated>
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    <udiDi>00821925027787</udiDi>
    <basicUdiDi>0821925000215B</basicUdiDi>
    <tradeName>00821925027787</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Gyrus ACMI, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000034237</manufacturerSrn>
    <authorisedRepresentativeName>Olympus Europa SE &amp; Co. KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006774</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12149080</emdnCode>
    <emdnDescription>VARIOUS ENT INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MDFS100</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:43:41.721Z</lastUpdated>
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    <udiDi>00817020020075</udiDi>
    <basicUdiDi>08172002M010300EP</basicUdiDi>
    <tradeName>USB Jr Duet</tradeName>
    <deviceName>USB Jr Duet</deviceName>
    <manufacturerName>Intelligent Hearing Systems Corp.</manufacturerName>
    <manufacturerSrn>US-MF-000011473</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12149001</emdnCode>
    <emdnDescription>OTOACOUSTIC EMISSIONS EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M010300</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:26:41.818Z</lastUpdated>
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    <udiDi>00763000811082</udiDi>
    <basicUdiDi>0763000B00027828T</basicUdiDi>
    <tradeName>00763000811082</tradeName>
    <deviceName>EM ENT Suction</deviceName>
    <manufacturerName>Medtronic Navigation Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000023263</manufacturerSrn>
    <authorisedRepresentativeName>Medtronic B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000006050</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12140580</emdnCode>
    <emdnDescription>STEREOTACTIC ENT SURGERY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9733449</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:08:07.976Z</lastUpdated>
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    <tradeName>Disposable Ear Speculum 2,5 mm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hammarplast Medical AB</manufacturerName>
    <manufacturerSrn>SE-MF-000009420</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12149085</emdnCode>
    <emdnDescription>VARIOUS ENT INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>31110</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:01:41.556Z</lastUpdated>
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    <basicUdiDi>07181752095A</basicUdiDi>
    <tradeName>BALANCE SYSTEM SD 230V</tradeName>
    <deviceName>Balance System</deviceName>
    <manufacturerName>Biodex Medical Systems</manufacturerName>
    <manufacturerSrn>US-MF-000028834</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12140404</emdnCode>
    <emdnDescription>POSTUROGRAPHY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>950-441</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T23:43:55.895Z</lastUpdated>
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    <udiDi>00714646000705</udiDi>
    <basicUdiDi>0714646OtoClearTipRW</basicUdiDi>
    <tradeName>OtoClear Tips</tradeName>
    <deviceName>OtoClear Tips</deviceName>
    <manufacturerName>Bionix LLC</manufacturerName>
    <manufacturerSrn>US-MF-000020408</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12149099</emdnCode>
    <emdnDescription>VARIOUS ENT INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7200ST</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-15T23:43:54.472Z</lastUpdated>
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    <tradeName>Adstation™</tradeName>
    <deviceName>Throat Illuminator and parts</deviceName>
    <manufacturerName>American Diagnostic Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000021544</manufacturerSrn>
    <authorisedRepresentativeName>S.C. Cattus S.R.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>RO-AR-000020096</authorisedRepresentativeSrn>
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    <emdnDescription>DIRECT OUTPATIENT OTOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5610L-36L</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-15T22:06:55.172Z</lastUpdated>
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    <manufacturerName>American Diagnostic Corporation</manufacturerName>
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    <emdnDescription>DIRECT OUTPATIENT OTOSCOPES</emdnDescription>
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    <reference>5211</reference>
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    <lastUpdated>2026-07-15T22:06:47.172Z</lastUpdated>
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    <tradeName>ABR-S</tradeName>
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    <emdnCode>Z12140380</emdnCode>
    <emdnDescription>EVOKED POTENTIAL AUDIOMETRY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>101001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:40:11.073Z</lastUpdated>
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    <manufacturerName>PATH MEDICAL GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006935</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12140302</emdnCode>
    <emdnDescription>EVOKED POTENTIAL AUDIOMETRY EQUIPMENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>101003</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:40:10.236Z</lastUpdated>
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