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    <basicUdiDi>B-20385081120095</basicUdiDi>
    <tradeName>Omnipod Insulin Management System</tradeName>
    <deviceName>SKT-DET450</deviceName>
    <manufacturerName>Insulet Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000007948</manufacturerSrn>
    <authorisedRepresentativeName>Insulet Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002337</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z120402160102</emdnCode>
    <emdnDescription>PORTABLE INSULIN MICROINFUSORS WITH HANDHELD GLUCOSE METER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18916-5F</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:05:56.582Z</lastUpdated>
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    <udiDi>20385081120033</udiDi>
    <basicUdiDi>B-20385081120033</basicUdiDi>
    <tradeName>Omnipod Insulin Management System</tradeName>
    <deviceName>Omnipod Insulin Management System</deviceName>
    <manufacturerName>Insulet Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000007948</manufacturerSrn>
    <authorisedRepresentativeName>Insulet Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002337</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
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    <emdnDescription>PORTABLE INSULIN MICROINFUSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZXP425</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:05:52.838Z</lastUpdated>
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    <udiDi>20385081120088</udiDi>
    <basicUdiDi>B-20385081120088</basicUdiDi>
    <tradeName>Omnipod Insulin Management System</tradeName>
    <deviceName>SKT-DET400</deviceName>
    <manufacturerName>Insulet Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000007948</manufacturerSrn>
    <authorisedRepresentativeName>Insulet Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002337</authorisedRepresentativeSrn>
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    <legislation>MDD</legislation>
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    <emdnDescription>PORTABLE INSULIN MICROINFUSORS WITH HANDHELD GLUCOSE METER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18916-5E</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:05:51.943Z</lastUpdated>
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    <udiDi>20385081120071</udiDi>
    <basicUdiDi>B-20385081120071</basicUdiDi>
    <tradeName>Omnipod Insulin Management System</tradeName>
    <deviceName>SKT-FRT400</deviceName>
    <manufacturerName>Insulet Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000007948</manufacturerSrn>
    <authorisedRepresentativeName>Insulet Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002337</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z120402160102</emdnCode>
    <emdnDescription>PORTABLE INSULIN MICROINFUSORS WITH HANDHELD GLUCOSE METER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18916-5D</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:05:51.885Z</lastUpdated>
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    <udiDi>04251978601140</udiDi>
    <basicUdiDi>42519786030022D</basicUdiDi>
    <tradeName>Abdomen-Sensor komplett</tradeName>
    <deviceName>Respiratory Effort Sensor</deviceName>
    <manufacturerName>Dr. Fenyves und Gut Deutschland GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005715</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12040180</emdnCode>
    <emdnDescription>GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>925380</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T11:20:12.138Z</lastUpdated>
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    <udiDi>04251978600112</udiDi>
    <basicUdiDi>42519786030022D</basicUdiDi>
    <tradeName>Thorax-Sensor komplett</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Dr. Fenyves und Gut Deutschland GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005715</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12040180</emdnCode>
    <emdnDescription>GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>929140</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T11:20:10.163Z</lastUpdated>
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    <udiDi>04251978600198</udiDi>
    <basicUdiDi>42519786030022D</basicUdiDi>
    <tradeName>Effortsensor gerätenah</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Dr. Fenyves und Gut Deutschland GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005715</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12040180</emdnCode>
    <emdnDescription>GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>930393</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T11:20:10.057Z</lastUpdated>
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    <udiDi>04251978600204</udiDi>
    <basicUdiDi>42519786030022D</basicUdiDi>
    <tradeName>Effortsensor gerätefern</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Dr. Fenyves und Gut Deutschland GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005715</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12040180</emdnCode>
    <emdnDescription>GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>930394</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T11:20:10.012Z</lastUpdated>
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    <udiDi>04251978600211</udiDi>
    <basicUdiDi>42519786030022D</basicUdiDi>
    <tradeName>Effortsensor für Kinder, komplett</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Dr. Fenyves und Gut Deutschland GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005715</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12040180</emdnCode>
    <emdnDescription>GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>930395</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T11:20:09.959Z</lastUpdated>
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    <udiDi>04251978600228</udiDi>
    <basicUdiDi>42519786030022D</basicUdiDi>
    <tradeName>Effortsensor, Anschluss 2 m</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Dr. Fenyves und Gut Deutschland GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005715</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12040180</emdnCode>
    <emdnDescription>GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>930398</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T11:20:09.921Z</lastUpdated>
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    <udiDi>04251978600235</udiDi>
    <basicUdiDi>42519786030022D</basicUdiDi>
    <tradeName>Thorax-Sensor für Kinder, komplett</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Dr. Fenyves und Gut Deutschland GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005715</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12040180</emdnCode>
    <emdnDescription>GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>929150</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T11:20:09.888Z</lastUpdated>
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    <udiDi>04251978600280</udiDi>
    <basicUdiDi>42519786030022D</basicUdiDi>
    <tradeName>Thorax-Sensor für Kinder, komplett</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Dr. Fenyves und Gut Deutschland GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005715</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12040180</emdnCode>
    <emdnDescription>GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>925150</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T11:20:09.744Z</lastUpdated>
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    <udiDi>04251978600297</udiDi>
    <basicUdiDi>42519786030022D</basicUdiDi>
    <tradeName>Effortsensor, Anschluss 2 m gerätenah</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Dr. Fenyves und Gut Deutschland GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005715</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12040180</emdnCode>
    <emdnDescription>GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>930397</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T11:20:09.693Z</lastUpdated>
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    <udiDi>04251978601225</udiDi>
    <basicUdiDi>42519786030022D</basicUdiDi>
    <tradeName>Thorax-Sensor komplett, 2 m</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Dr. Fenyves und Gut Deutschland GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005715</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12040180</emdnCode>
    <emdnDescription>GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>925145</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T11:19:50.244Z</lastUpdated>
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    <udiDi>04251978601393</udiDi>
    <basicUdiDi>42519786030022D</basicUdiDi>
    <tradeName>Thorax-Sensor komplett, 2 m</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Dr. Fenyves und Gut Deutschland GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005715</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
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    <emdnCode>Z12040180</emdnCode>
    <emdnDescription>GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>930143</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T11:19:50.143Z</lastUpdated>
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    <udiDi>04719897813407</udiDi>
    <basicUdiDi>471094933CGM000109K</basicUdiDi>
    <tradeName>Inreda</tradeName>
    <deviceName>RIGHTEST iFree 2 Continuous Glucose Monitoring System Transmitter set</deviceName>
    <manufacturerName>Bionime Corporation</manufacturerName>
    <manufacturerSrn>TW-MF-000008450</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
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    <emdnCode>Z1204011599</emdnCode>
    <emdnDescription>BLOOD SUGAR MONITORING SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>I0C069</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-30T03:52:36.356Z</lastUpdated>
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    <tradeName>RIGHTEST iFree2</tradeName>
    <deviceName>RIGHTEST iFree 2 Continuous Glucose Monitoring System Sensor kit</deviceName>
    <manufacturerName>Bionime Corporation</manufacturerName>
    <manufacturerSrn>TW-MF-000008450</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1204011585</emdnCode>
    <emdnDescription>INVASIVE BLOOD SUGAR MONITORING SYSTEMS, SINGLE–USE SENSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R0C066</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-29T23:38:25.523Z</lastUpdated>
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    <tradeName>RIGHTEST iFree</tradeName>
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    <manufacturerName>Bionime Corporation</manufacturerName>
    <manufacturerSrn>TW-MF-000008450</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>R0C014</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-29T23:38:24.709Z</lastUpdated>
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    <tradeName>HydraFacial</tradeName>
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    <manufacturerName>Hydrafacial, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000004431</manufacturerSrn>
    <authorisedRepresentativeName>E C REP LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003995</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
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    <emdnCode>Z12040299</emdnCode>
    <emdnDescription>GENERAL MEDICINE THERAPEUTIC TREATMENT INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>74111</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-28T09:01:50.053Z</lastUpdated>
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    <manufacturerName>Hydrafacial, LLC</manufacturerName>
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    <emdnDescription>GENERAL MEDICINE THERAPEUTIC TREATMENT INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>74112</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-28T09:01:50.035Z</lastUpdated>
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