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    <manufacturerName>Dymedix Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000015691</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
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    <legislation>UNKNOWN</legislation>
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    <reference>11-15000-0050</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-26T14:52:06.747Z</lastUpdated>
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    <tradeName>EEG Electrodes</tradeName>
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    <manufacturerName>Dymedix Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000015691</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
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    <legislation>UNKNOWN</legislation>
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    <basicUdiDi>08173770213101007G</basicUdiDi>
    <tradeName>EEG Electrodes</tradeName>
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    <manufacturerName>Dymedix Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000015691</manufacturerSrn>
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    <basicUdiDi>08173770213101007G</basicUdiDi>
    <tradeName>EEG Electrodes</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Dymedix Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000015691</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
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    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12100585</emdnCode>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>13-10100-1010</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
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    <tradeName>TriplePlay</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Dymedix Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000015691</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12100585</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10-40000-0501</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-26T14:52:06.619Z</lastUpdated>
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    <udiDi>00817377022951</udiDi>
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    <tradeName>PerfectFit</tradeName>
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    <manufacturerName>Dymedix Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000015691</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12100585</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11-42810-0601</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-26T14:52:06.568Z</lastUpdated>
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    <manufacturerName>Dymedix Diagnostics, Inc.</manufacturerName>
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    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12100585</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11-43200-6001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-26T14:52:06.549Z</lastUpdated>
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    <tradeName>PerfectFit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Dymedix Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000015691</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12100585</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11-94320-0601</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-26T14:52:06.526Z</lastUpdated>
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    <basicUdiDi>08173770211100006H</basicUdiDi>
    <tradeName>PerfectFit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Dymedix Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000015691</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12100585</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11-94321-0601</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-26T14:52:06.503Z</lastUpdated>
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    <udiDi>00817377022999</udiDi>
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    <tradeName>PerfectFit</tradeName>
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    <manufacturerName>Dymedix Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000015691</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12100585</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11-94330-0602</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-26T14:52:06.483Z</lastUpdated>
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    <udiDi>00817377023019</udiDi>
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    <tradeName>FastTrack Effort Belt</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Dymedix Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000015691</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12100585</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11-44200-7501</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-26T14:52:06.443Z</lastUpdated>
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    <tradeName>FastTrack Effort Belt</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Dymedix Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000015691</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12100585</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11-44300-7502</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-26T14:52:06.417Z</lastUpdated>
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    <tradeName>FastTrack Effort Belt</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Dymedix Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000015691</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
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    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12100585</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18-14250-0601</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
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    <manufacturerName>Dymedix Diagnostics, Inc.</manufacturerName>
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    <lastUpdated>2026-07-26T14:52:06.371Z</lastUpdated>
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    <tradeName>FastTrack Effort Belt</tradeName>
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    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
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    <manufacturerName>Dymedix Diagnostics, Inc.</manufacturerName>
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    <emdnCode>Z12100585</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry></placedOnMarketCountry>
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    <tradeName>EEG Electrodes</tradeName>
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    <manufacturerName>Dymedix Diagnostics, Inc.</manufacturerName>
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    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12100585</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHY INSTRUMENTS - CONSUMABLES</emdnDescription>
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    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry></placedOnMarketCountry>
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