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    <tradeName>Alice 5 International Base Unit Only</tradeName>
    <deviceName>Alice 5 and Alice LE Polysomnography Systems</deviceName>
    <manufacturerName>Respironics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002301</manufacturerSrn>
    <authorisedRepresentativeName>Respironics Deutschland GmbH &amp; Co.KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006164</authorisedRepresentativeSrn>
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    <reference>1017230</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:02:09.333Z</lastUpdated>
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    <udiDi>00606959020245</udiDi>
    <basicUdiDi>B-00606959020245</basicUdiDi>
    <tradeName>Alice LE System INTL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Respironics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002301</manufacturerSrn>
    <authorisedRepresentativeName>Respironics Deutschland GmbH &amp; Co.KG</authorisedRepresentativeName>
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    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>1002288</reference>
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    <lastUpdated>2026-07-04T14:02:04.526Z</lastUpdated>
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    <basicUdiDi>9342451FalconH9</basicUdiDi>
    <tradeName>09342451002747</tradeName>
    <deviceName>Falcon HST</deviceName>
    <manufacturerName>Compumedics Limited</manufacturerName>
    <manufacturerSrn>AU-MF-000050437</manufacturerSrn>
    <authorisedRepresentativeName>Compumedics EUROPE GmbH</authorisedRepresentativeName>
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    <basicUdiDi>9342451SomfitTU</basicUdiDi>
    <tradeName>09342451002655</tradeName>
    <deviceName>Somfit System</deviceName>
    <manufacturerName>Compumedics Limited</manufacturerName>
    <manufacturerSrn>AU-MF-000050437</manufacturerSrn>
    <authorisedRepresentativeName>Compumedics EUROPE GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000039096</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12100501</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8037-0001-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T21:05:09.377Z</lastUpdated>
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    <udiDi>09342451001382</udiDi>
    <basicUdiDi>9342451SomtePSGTN</basicUdiDi>
    <tradeName>09342451001382</tradeName>
    <deviceName>Somte PSG v2</deviceName>
    <manufacturerName>Compumedics Limited</manufacturerName>
    <manufacturerSrn>AU-MF-000050437</manufacturerSrn>
    <authorisedRepresentativeName>Compumedics EUROPE GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000039096</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12100501</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8023-0001-02</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T21:05:03.787Z</lastUpdated>
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    <udiDi>04251978600914</udiDi>
    <basicUdiDi>42519786020052C</basicUdiDi>
    <tradeName>SleepDoc Porti 10 PSG Patient Recorder</tradeName>
    <deviceName>Polysomnographgerät</deviceName>
    <manufacturerName>Dr. Fenyves und Gut Deutschland GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005715</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12100501</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>930011</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T19:14:39.695Z</lastUpdated>
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    <udiDi>04250413404384</udiDi>
    <basicUdiDi>42504134PSGSC</basicUdiDi>
    <tradeName>SOMNOtouch™ RESP</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SOMNOmedics AG</manufacturerName>
    <manufacturerSrn>DE-MF-000006921</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12100501</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TOR050</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T18:31:40.160Z</lastUpdated>
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    <udiDi>04250413403837</udiDi>
    <basicUdiDi>42504134SleepA36</basicUdiDi>
    <tradeName>Sleep Adagio® PG</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SOMNOmedics AG</manufacturerName>
    <manufacturerSrn>DE-MF-000006921</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
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    <emdnCode>Z12100501</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SAZ050</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T18:31:36.950Z</lastUpdated>
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    <basicUdiDi>42504134SOMNOHDND</basicUdiDi>
    <tradeName>SOMNO HD PSG eco with PTZ Camera</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SOMNOmedics AG</manufacturerName>
    <manufacturerSrn>DE-PR-000042026</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12100501</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NGNV202A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T18:31:25.751Z</lastUpdated>
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    <udiDi>04250413402168</udiDi>
    <basicUdiDi>42504134SOMNOtouchRESPZS</basicUdiDi>
    <tradeName>Add-on device: SOMNOtouch RESP (pediatric)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SOMNOmedics AG</manufacturerName>
    <manufacturerSrn>DE-PR-000042026</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12100501</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TOR105A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T18:31:08.045Z</lastUpdated>
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    <udiDi>04250413400195</udiDi>
    <basicUdiDi>42504134SSCPKB</basicUdiDi>
    <tradeName>SOMNOscreen™ plus</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SOMNOmedics AG</manufacturerName>
    <manufacturerSrn>DE-MF-000006921</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12100501</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SSP704</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T18:30:46.852Z</lastUpdated>
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    <basicUdiDi>42504134SOMNOscreenplusEQ</basicUdiDi>
    <tradeName>SOMNOscreen plus RC easy</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SOMNOmedics AG</manufacturerName>
    <manufacturerSrn>DE-PR-000042026</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12100501</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SSP500</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T18:30:44.826Z</lastUpdated>
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    <udiDi>03770035921027</udiDi>
    <basicUdiDi>3770035921SLEEPSCANMG</basicUdiDi>
    <tradeName>SLEEPSCAN</tradeName>
    <deviceName>SLEEPSCAN</deviceName>
    <manufacturerName>SOMNO ENGINEERING</manufacturerName>
    <manufacturerSrn>FR-MF-000043221</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12100501</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>327-1847DF777</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T13:14:53.011Z</lastUpdated>
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    <udiDi>15694311112082</udiDi>
    <basicUdiDi>1569431111NOX_A1SSASKITYY</basicUdiDi>
    <tradeName>Nox A1S SAS kit</tradeName>
    <deviceName>Nox A1s System with SAS</deviceName>
    <manufacturerName>Nox Medical</manufacturerName>
    <manufacturerSrn>IS-PR-000054327</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12100501</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>513013</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T09:09:06.403Z</lastUpdated>
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    <basicUdiDi>1569431111NOX_A1KITQA</basicUdiDi>
    <tradeName>A1s System</tradeName>
    <deviceName>Nox A1s System with WristOx2</deviceName>
    <manufacturerName>Nox Medical</manufacturerName>
    <manufacturerSrn>IS-PR-000054327</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
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    <emdnCode>Z12100501</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>513012</reference>
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    <lastUpdated>2026-07-01T09:09:04.794Z</lastUpdated>
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    <tradeName>Nox T3s System, EU</tradeName>
    <deviceName>Nox T3s System with WristOx2</deviceName>
    <manufacturerName>Nox Medical</manufacturerName>
    <manufacturerSrn>IS-PR-000054327</manufacturerSrn>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>511012</reference>
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    <lastUpdated>2026-07-01T09:08:47.945Z</lastUpdated>
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    <basicUdiDi>69485383SD001T3</basicUdiDi>
    <tradeName>Polypro Polysomnograph</tradeName>
    <deviceName>Sleep Apnea Diagnosis Device</deviceName>
    <manufacturerName>BMC Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010157</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
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    <emdnDescription>POLYSOMNOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H2 Pro</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-28T01:16:07.711Z</lastUpdated>
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    <basicUdiDi>69485383SD001T3</basicUdiDi>
    <tradeName>Polypro Polysomnograph</tradeName>
    <deviceName>Sleep Apnea Diagnosis Device</deviceName>
    <manufacturerName>BMC Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010157</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
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    <emdnDescription>POLYSOMNOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H2 Elite</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-28T01:16:01.718Z</lastUpdated>
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    <tradeName>Polypro Portable Sleep Diagnostic System</tradeName>
    <deviceName>Sleep Apnea Diagnosis Device</deviceName>
    <manufacturerName>BMC Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010157</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>H2 Plus</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-28T01:16:00.522Z</lastUpdated>
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    <tradeName>Polypro Portable Sleep Diagnostic System</tradeName>
    <deviceName>Sleep Apnea Diagnosis Device</deviceName>
    <manufacturerName>BMC Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010157</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
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    <riskClass>Sınıf IIa</riskClass>
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    <emdnCode>Z12100501</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H2</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-28T01:15:59.304Z</lastUpdated>
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