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    <manufacturerName>Respironics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002301</manufacturerSrn>
    <authorisedRepresentativeName>Respironics Deutschland GmbH &amp; Co.KG</authorisedRepresentativeName>
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    <lastUpdated>2026-07-04T14:08:45.094Z</lastUpdated>
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    <tradeName>Actiware Software Web Download - 6</tradeName>
    <deviceName>Actiware Software, Actiware CT Software</deviceName>
    <manufacturerName>Respironics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002301</manufacturerSrn>
    <authorisedRepresentativeName>Respironics Deutschland GmbH &amp; Co.KG</authorisedRepresentativeName>
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    <tradeName>Actiware Software CD - 6</tradeName>
    <deviceName>Actiware Software, Actiware CT Software</deviceName>
    <manufacturerName>Respironics Inc.</manufacturerName>
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    <authorisedRepresentativeName>Respironics Deutschland GmbH &amp; Co.KG</authorisedRepresentativeName>
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    <basicUdiDi>B-00606959021402</basicUdiDi>
    <tradeName>Actiwatch Spectrum PRO</tradeName>
    <deviceName>Actiwatch Spectrum Pro and Actiwatch Spe</deviceName>
    <manufacturerName>Respironics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002301</manufacturerSrn>
    <authorisedRepresentativeName>Respironics Deutschland GmbH &amp; Co.KG</authorisedRepresentativeName>
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    <legislation>MDD</legislation>
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    <emdnDescription>METABOLIC AND PHYSICAL ACTIVITY HOLTER SYSTEMS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>1099351</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:03:03.819Z</lastUpdated>
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    <tradeName>Actiwatch Spectrum Device</tradeName>
    <deviceName>Actiwatch 2 and Actiwatch Spectrum</deviceName>
    <manufacturerName>Respironics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002301</manufacturerSrn>
    <authorisedRepresentativeName>Respironics Deutschland GmbH &amp; Co.KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006164</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12040117</emdnCode>
    <emdnDescription>METABOLIC AND PHYSICAL ACTIVITY HOLTER SYSTEMS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>1048091</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:02:19.739Z</lastUpdated>
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    <udiDi>00386270002792</udiDi>
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    <tradeName>Dexcom ONE Continuous Glucose Monitoring System</tradeName>
    <deviceName>Dexcom ONE Continuous Glucose Monitoring System</deviceName>
    <manufacturerName>Dexcom</manufacturerName>
    <manufacturerSrn>US-MF-000010694</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1204011585</emdnCode>
    <emdnDescription>INVASIVE BLOOD SUGAR MONITORING SYSTEMS, SINGLE–USE SENSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>STK-DO-109</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T13:50:57.234Z</lastUpdated>
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    <basicUdiDi>B-00386270002785</basicUdiDi>
    <tradeName>Dexcom ONE Continuous Glucose Monitoring System</tradeName>
    <deviceName>Dexcom ONE Continuous Glucose Monitoring System</deviceName>
    <manufacturerName>Dexcom</manufacturerName>
    <manufacturerSrn>US-MF-000010694</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
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    <legislation>MDD</legislation>
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    <emdnDescription>INVASIVE BLOOD SUGAR MONITORING SYSTEMS, SINGLE–USE SENSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>STT-DO-001</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-04T13:50:54.821Z</lastUpdated>
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    <basicUdiDi>B-00386270002778</basicUdiDi>
    <tradeName>Dexcom ONE Continuous Glucose Monitoring System</tradeName>
    <deviceName>Dexcom ONE Continuous Glucose Monitoring System</deviceName>
    <manufacturerName>Dexcom</manufacturerName>
    <manufacturerSrn>US-MF-000010694</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1204011585</emdnCode>
    <emdnDescription>INVASIVE BLOOD SUGAR MONITORING SYSTEMS, SINGLE–USE SENSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>STP-DO-002</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-04T13:50:53.223Z</lastUpdated>
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    <udiDi>00386270002761</udiDi>
    <basicUdiDi>B-00386270002761</basicUdiDi>
    <tradeName>Dexcom ONE Continuous Glucose Monitoring System</tradeName>
    <deviceName>Dexcom ONE Continuous Glucose Monitoring System</deviceName>
    <manufacturerName>Dexcom</manufacturerName>
    <manufacturerSrn>US-MF-000010694</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1204011585</emdnCode>
    <emdnDescription>INVASIVE BLOOD SUGAR MONITORING SYSTEMS, SINGLE–USE SENSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>STP-DO-109</reference>
    <placedOnMarketCountry>Croatia</placedOnMarketCountry>
    <lastUpdated>2026-07-04T13:50:52.420Z</lastUpdated>
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    <udiDi>00386270002747</udiDi>
    <basicUdiDi>B-00386270002747</basicUdiDi>
    <tradeName>Dexcom ONE Continuous Glucose Monitoring System</tradeName>
    <deviceName>Dexcom ONE Continuous Glucose Monitoring System</deviceName>
    <manufacturerName>Dexcom</manufacturerName>
    <manufacturerSrn>US-MF-000010694</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1204011585</emdnCode>
    <emdnDescription>INVASIVE BLOOD SUGAR MONITORING SYSTEMS, SINGLE–USE SENSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>STP-DO-101</reference>
    <placedOnMarketCountry>Estonia</placedOnMarketCountry>
    <lastUpdated>2026-07-04T13:50:50.827Z</lastUpdated>
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    <udiDi>00386270002327</udiDi>
    <basicUdiDi>B-00386270002327</basicUdiDi>
    <tradeName>Dexcom ONE Continuous Glucose Monitoring System</tradeName>
    <deviceName>Dexcom ONE Continuous Glucose Monitoring System</deviceName>
    <manufacturerName>Dexcom</manufacturerName>
    <manufacturerSrn>US-MF-000010694</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1204011585</emdnCode>
    <emdnDescription>INVASIVE BLOOD SUGAR MONITORING SYSTEMS, SINGLE–USE SENSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>STK-DO-013</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-04T13:50:48.422Z</lastUpdated>
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    <udiDi>00386270002297</udiDi>
    <basicUdiDi>B-00386270002297</basicUdiDi>
    <tradeName>Dexcom ONE Continuous Glucose Monitoring System</tradeName>
    <deviceName>Dexcom ONE Continuous Glucose Monitoring System</deviceName>
    <manufacturerName>Dexcom</manufacturerName>
    <manufacturerSrn>US-MF-000010694</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1204011585</emdnCode>
    <emdnDescription>INVASIVE BLOOD SUGAR MONITORING SYSTEMS, SINGLE–USE SENSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>STP-DO-005</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-04T13:50:46.819Z</lastUpdated>
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    <udiDi>00386270001849</udiDi>
    <basicUdiDi>B-00386270001849</basicUdiDi>
    <tradeName>Dexcom ONE Continuous Glucose Monitoring System</tradeName>
    <deviceName>Dexcom ONE Continuous Glucose Monitoring System</deviceName>
    <manufacturerName>Dexcom</manufacturerName>
    <manufacturerSrn>US-MF-000010694</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1204011585</emdnCode>
    <emdnDescription>INVASIVE BLOOD SUGAR MONITORING SYSTEMS, SINGLE–USE SENSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>STP-DO-102</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T13:50:46.016Z</lastUpdated>
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    <udiDi>00386270001832</udiDi>
    <basicUdiDi>B-00386270001832</basicUdiDi>
    <tradeName>Dexcom ONE Continuous Glucose Monitoring System</tradeName>
    <deviceName>Dexcom ONE Continuous Glucose Monitoring System</deviceName>
    <manufacturerName>Dexcom</manufacturerName>
    <manufacturerSrn>US-MF-000010694</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
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    <legislation>MDD</legislation>
    <emdnCode>Z1204011585</emdnCode>
    <emdnDescription>INVASIVE BLOOD SUGAR MONITORING SYSTEMS, SINGLE–USE SENSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>STS-DO-003</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-04T13:50:44.435Z</lastUpdated>
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    <udiDi>00386270001825</udiDi>
    <basicUdiDi>B-00386270001825</basicUdiDi>
    <tradeName>Dexcom ONE Continuous Glucose Monitoring System</tradeName>
    <deviceName>Dexcom ONE Continuous Glucose Monitoring System</deviceName>
    <manufacturerName>Dexcom</manufacturerName>
    <manufacturerSrn>US-MF-000010694</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
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    <emdnDescription>INVASIVE BLOOD SUGAR MONITORING SYSTEMS, SINGLE–USE SENSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>STS-DO-001</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-04T13:50:42.049Z</lastUpdated>
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    <udiDi>00386270000651</udiDi>
    <basicUdiDi>B-00386270000651</basicUdiDi>
    <tradeName>Dexcom ONE Continuous Glucose Monitoring System</tradeName>
    <deviceName>Dexcom ONE Continuous Glucose Monitoring System</deviceName>
    <manufacturerName>Dexcom</manufacturerName>
    <manufacturerSrn>US-MF-000010694</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
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    <emdnDescription>INVASIVE BLOOD SUGAR MONITORING SYSTEMS, SINGLE–USE SENSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>STP-DO-003</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-04T13:50:40.419Z</lastUpdated>
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    <udiDi>+EH4DCSTK0017</udiDi>
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    <tradeName>Consult Station</tradeName>
    <deviceName></deviceName>
    <manufacturerName>H4D</manufacturerName>
    <manufacturerSrn>FR-MF-000001380</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnDescription>GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>CS</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-04T05:06:47.886Z</lastUpdated>
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    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>MDD</legislation>
    <emdnCode>Z12040182</emdnCode>
    <emdnDescription>GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>Consult Access</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-04T05:06:45.491Z</lastUpdated>
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    <emdnDescription>GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - SOFTWARE ACCESSORIES</emdnDescription>
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    <lastUpdated>2026-07-03T21:03:35.617Z</lastUpdated>
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    <deviceStatus>Artık piyasada değil</deviceStatus>
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    <lastUpdated>2026-07-03T21:03:34.013Z</lastUpdated>
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