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    <tradeName>Snugglefit Effort Belt</tradeName>
    <deviceName>Snuggle Fit</deviceName>
    <manufacturerName>Dymedix Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000015691</manufacturerSrn>
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    <reference>11-14002-1001</reference>
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    <tradeName>TriplePlay</tradeName>
    <deviceName>Movement Sensor</deviceName>
    <manufacturerName>Dymedix Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000015691</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
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    <tradeName>EMG Surface Electrodes</tradeName>
    <deviceName>MotionWave</deviceName>
    <manufacturerName>Dymedix Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000015691</manufacturerSrn>
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    <tradeName>FastTrack Effort Belt</tradeName>
    <deviceName>FastTrack</deviceName>
    <manufacturerName>Dymedix Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000015691</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>12-10150-0001</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:27:25.023Z</lastUpdated>
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    <udiDi>00817377020131</udiDi>
    <basicUdiDi>08173770211450008M</basicUdiDi>
    <tradeName>Perfect Fit 3D Effort Belt</tradeName>
    <deviceName>Perfect Fit 3D Effort Belt</deviceName>
    <manufacturerName>Dymedix Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000015691</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>11-14001-5001</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:27:23.427Z</lastUpdated>
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    <udiDi>00817377020124</udiDi>
    <basicUdiDi>08173770211100006H</basicUdiDi>
    <tradeName>PerfectFit</tradeName>
    <deviceName>Perfect Fit II Effort Belts</deviceName>
    <manufacturerName>Dymedix Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000015691</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
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    <emdnDescription>POLYSOMNOGRAPHY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11-22100-0301</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:27:21.015Z</lastUpdated>
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    <basicUdiDi>08173770213100007B</basicUdiDi>
    <tradeName>AccuSnore</tradeName>
    <deviceName>AccuSnore Disposable Snore Sensors</deviceName>
    <manufacturerName>Dymedix Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000015691</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
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    <emdnDescription>POLYSOMNOGRAPHY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10-21001-0301</reference>
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    <lastUpdated>2026-07-16T01:27:20.681Z</lastUpdated>
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    <tradeName>TriplePlay Airflow</tradeName>
    <deviceName>TriplePlan Airflow</deviceName>
    <manufacturerName>Dymedix Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000015691</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>10-10000-0001</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:27:18.667Z</lastUpdated>
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    <basicUdiDi>081711102THERM2W</basicUdiDi>
    <tradeName>00817111021004</tradeName>
    <deviceName>TH01 Thermocouple Sensor</deviceName>
    <manufacturerName>Neurotronics, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000030839</manufacturerSrn>
    <authorisedRepresentativeName>NIHON KOHDEN EUROPE GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010740</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
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    <emdnCode>Z12100580</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S29604</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:26:54.996Z</lastUpdated>
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    <udiDi>00817111020960</udiDi>
    <basicUdiDi>081711102PIEZO2M</basicUdiDi>
    <tradeName>00817111020960</tradeName>
    <deviceName>PZ01 Piezo Sensor</deviceName>
    <manufacturerName>Neurotronics, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000030839</manufacturerSrn>
    <authorisedRepresentativeName>NIHON KOHDEN EUROPE GmbH</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>S60780</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:26:54.791Z</lastUpdated>
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    <basicUdiDi>081711102RIPBC</basicUdiDi>
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    <deviceName>RIP01 RIP Sensor</deviceName>
    <manufacturerName>Neurotronics, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000030839</manufacturerSrn>
    <authorisedRepresentativeName>NIHON KOHDEN EUROPE GmbH</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>S43359</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:26:53.452Z</lastUpdated>
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    <basicUdiDi>081711102BODY2V</basicUdiDi>
    <tradeName>00817111020823</tradeName>
    <deviceName>BP01 Body Position Sensor</deviceName>
    <manufacturerName>Neurotronics, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000030839</manufacturerSrn>
    <authorisedRepresentativeName>NIHON KOHDEN EUROPE GmbH</authorisedRepresentativeName>
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    <emdnDescription>POLYSOMNOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S17926</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:26:52.344Z</lastUpdated>
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    <tradeName>NICO BrainPath</tradeName>
    <deviceName>Shepherd's Hook</deviceName>
    <manufacturerName>NICO Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000000769</manufacturerSrn>
    <authorisedRepresentativeName>Atlantico Systems, Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000208</authorisedRepresentativeSrn>
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    <legislation>MDR 2017/745</legislation>
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    <emdnDescription>VARIOUS NEUROLOGY AND NEUROSURGERY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NN-8024</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:22:11.517Z</lastUpdated>
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    <udiDi>00816744022501</udiDi>
    <basicUdiDi>081674402PP1FG</basicUdiDi>
    <tradeName>NICO BrainPath Approach</tradeName>
    <deviceName>NICO BrainPath Approach</deviceName>
    <manufacturerName>NICO Corporation</manufacturerName>
    <manufacturerSrn>US-PR-000035011</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <lastUpdated>2026-07-16T01:22:00.692Z</lastUpdated>
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    <tradeName>Monopolar Stimulating Probe</tradeName>
    <deviceName>Electrical Neuromuscular Stimulating Probes</deviceName>
    <manufacturerName>Rhythmlink International, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000012131</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>RLSP494</reference>
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    <lastUpdated>2026-07-16T01:21:15.424Z</lastUpdated>
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    <tradeName>Ultium EMG Sensor</tradeName>
    <deviceName>Wireless EMG Family</deviceName>
    <manufacturerName>Noraxon USA, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003882</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
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    <lastUpdated>2026-07-16T01:20:55.425Z</lastUpdated>
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    <tradeName>Ultium Sensor Charger</tradeName>
    <deviceName>Wireless EMG Family Accessories</deviceName>
    <manufacturerName>Noraxon USA, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003882</manufacturerSrn>
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    <deviceName>StimRouter Electrodes - L</deviceName>
    <manufacturerName>Bioness Inc., a Bioventus Company</manufacturerName>
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    <reference>ST2-7001</reference>
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    <lastUpdated>2026-07-16T01:19:46.792Z</lastUpdated>
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    <tradeName>StimRouter Electrodes</tradeName>
    <deviceName>StimRouter Electrodes</deviceName>
    <manufacturerName>Bioness Inc., a Bioventus Company</manufacturerName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>ST2-7000</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
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    <tradeName>gammaCore Sapphire SLC Handset - Replacement</tradeName>
    <deviceName>gammaCore Sapphire</deviceName>
    <manufacturerName>ElectroCore, Inc.</manufacturerName>
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    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>20016-10301-RPL</reference>
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    <lastUpdated>2026-07-16T01:18:51.319Z</lastUpdated>
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