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    <tradeName>Tubing Flowsensors</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Transonic Systems Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000008784</manufacturerSrn>
    <authorisedRepresentativeName>Transonic Europe BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000004627</authorisedRepresentativeSrn>
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    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12040111</emdnCode>
    <emdnDescription>BLOOD FLOW METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HS6XL</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:18:31.453Z</lastUpdated>
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    <basicUdiDi>087746600HQHSSELE</basicUdiDi>
    <tradeName>Tubing Flowsensors</tradeName>
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    <manufacturerName>Transonic Systems Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000008784</manufacturerSrn>
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    <basicUdiDi>087746600HQHSSELE</basicUdiDi>
    <tradeName>Tubing Flowsensors</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Transonic Systems Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000008784</manufacturerSrn>
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    <tradeName>Tubing Flowsensors</tradeName>
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    <manufacturerName>Transonic Systems Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000008784</manufacturerSrn>
    <authorisedRepresentativeName>Transonic Europe BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000004627</authorisedRepresentativeSrn>
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    <emdnCode>Z12040111</emdnCode>
    <emdnDescription>BLOOD FLOW METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HS10XL</reference>
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    <basicUdiDi>087746600HQHSSELE</basicUdiDi>
    <tradeName>Tubing Flowsensors</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Transonic Systems Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000008784</manufacturerSrn>
    <authorisedRepresentativeName>Transonic Europe BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000004627</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12040111</emdnCode>
    <emdnDescription>BLOOD FLOW METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HS11XL</reference>
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    <lastUpdated>2026-07-16T03:18:31.346Z</lastUpdated>
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    <udiDi>00877466007979</udiDi>
    <basicUdiDi>087746600MOUNTSQS</basicUdiDi>
    <tradeName>FlowXL Short Pole Mount</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Transonic Systems Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000008784</manufacturerSrn>
    <authorisedRepresentativeName>Transonic Europe BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000004627</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12040199</emdnCode>
    <emdnDescription>GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FOS1015</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:18:31.282Z</lastUpdated>
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    <udiDi>00877466007986</udiDi>
    <basicUdiDi>087746600MOUNTSQS</basicUdiDi>
    <tradeName>FlowXL Long Pole Mount</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Transonic Systems Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000008784</manufacturerSrn>
    <authorisedRepresentativeName>Transonic Europe BV</authorisedRepresentativeName>
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    <emdnDescription>GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:18:31.255Z</lastUpdated>
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    <udiDi>00877466007993</udiDi>
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    <tradeName>FlowXL Tabletop Mount</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Transonic Systems Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000008784</manufacturerSrn>
    <authorisedRepresentativeName>Transonic Europe BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000004627</authorisedRepresentativeSrn>
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    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12040199</emdnCode>
    <emdnDescription>GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FOS1014</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:18:31.225Z</lastUpdated>
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    <udiDi>00877466008044</udiDi>
    <basicUdiDi>087746600HD03ST6Z</basicUdiDi>
    <tradeName>HD03 Patient-less Measurement Module</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Transonic Systems Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000008784</manufacturerSrn>
    <authorisedRepresentativeName>Transonic Europe BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000004627</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12040111</emdnCode>
    <emdnDescription>BLOOD FLOW METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PMM</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:18:31.200Z</lastUpdated>
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    <udiDi>00389152106113</udiDi>
    <basicUdiDi>0850018992TF-0009817MT</basicUdiDi>
    <tradeName>Tandem Source</tradeName>
    <deviceName>Tandem Source</deviceName>
    <manufacturerName>Tandem Diabetes Care, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000031791</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12040282</emdnCode>
    <emdnDescription>GENERAL MEDICINE THERAPEUTIC TREATMENT INSTRUMENTS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1011061</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:18:24.163Z</lastUpdated>
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    <udiDi>85001765129600</udiDi>
    <basicUdiDi>0850017651296TB</basicUdiDi>
    <tradeName>DERMLITE</tradeName>
    <deviceName>Visi-Shield for v900L, 2.5x</deviceName>
    <manufacturerName>DermLite LLC</manufacturerName>
    <manufacturerSrn>US-MF-000005170</manufacturerSrn>
    <authorisedRepresentativeName>E C REP LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003995</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12040108</emdnCode>
    <emdnDescription>DERMATOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V900L-50</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:16:53.349Z</lastUpdated>
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    <udiDi>08500176513332</udiDi>
    <basicUdiDi>0850017651333SQ</basicUdiDi>
    <tradeName>DERMLITE</tradeName>
    <deviceName>Syris v900L Charger &amp; Battery</deviceName>
    <manufacturerName>DermLite LLC</manufacturerName>
    <manufacturerSrn>US-MF-000005170</manufacturerSrn>
    <authorisedRepresentativeName>E C REP LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003995</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12040108</emdnCode>
    <emdnDescription>DERMATOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VTS1000-Charger</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:16:50.937Z</lastUpdated>
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    <udiDi>08500176513196</udiDi>
    <basicUdiDi>0850017651319SW</basicUdiDi>
    <tradeName>DERMLITE</tradeName>
    <deviceName>Headbands for v900L, 10-pk</deviceName>
    <manufacturerName>DermLite LLC</manufacturerName>
    <manufacturerSrn>US-MF-000005170</manufacturerSrn>
    <authorisedRepresentativeName>E C REP LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003995</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12040108</emdnCode>
    <emdnDescription>DERMATOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V900L-80</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:16:50.132Z</lastUpdated>
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    <udiDi>08500176513028</udiDi>
    <basicUdiDi>0850017651302SD</basicUdiDi>
    <tradeName>DERMLITE</tradeName>
    <deviceName>Visi-Shield for v900L, 2.0x</deviceName>
    <manufacturerName>DermLite LLC</manufacturerName>
    <manufacturerSrn>US-MF-000005170</manufacturerSrn>
    <authorisedRepresentativeName>E C REP LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003995</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12040108</emdnCode>
    <emdnDescription>DERMATOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V900L-40</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:16:47.732Z</lastUpdated>
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    <udiDi>08500176512892</udiDi>
    <basicUdiDi>0850017651289TE</basicUdiDi>
    <tradeName>DERMLITE</tradeName>
    <deviceName>Syris v900L Visualization System</deviceName>
    <manufacturerName>DermLite LLC</manufacturerName>
    <manufacturerSrn>US-MF-000005170</manufacturerSrn>
    <authorisedRepresentativeName>E C REP LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003995</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12040108</emdnCode>
    <emdnDescription>DERMATOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V900L</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:16:45.335Z</lastUpdated>
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    <udiDi>08500176512724</udiDi>
    <basicUdiDi>0850017651272SV</basicUdiDi>
    <tradeName>DERMLITE</tradeName>
    <deviceName>HÜD Home Skin Monitor</deviceName>
    <manufacturerName>DermLite LLC</manufacturerName>
    <manufacturerSrn>US-MF-000005170</manufacturerSrn>
    <authorisedRepresentativeName>E C REP LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003995</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12040108</emdnCode>
    <emdnDescription>DERMATOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HUD2</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:16:43.730Z</lastUpdated>
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    <basicUdiDi>0850017651265SY</basicUdiDi>
    <tradeName>DERMLITE</tradeName>
    <deviceName>DLCam Charger</deviceName>
    <manufacturerName>DermLite LLC</manufacturerName>
    <manufacturerSrn>US-MF-000005170</manufacturerSrn>
    <authorisedRepresentativeName>E C REP LIMITED</authorisedRepresentativeName>
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    <emdnDescription>DERMATOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DLCAM-CH</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:16:42.921Z</lastUpdated>
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    <udiDi>08500176512588</udiDi>
    <basicUdiDi>0850017651258T3</basicUdiDi>
    <tradeName>DERMLITE</tradeName>
    <deviceName>DLCam USB Cable</deviceName>
    <manufacturerName>DermLite LLC</manufacturerName>
    <manufacturerSrn>US-MF-000005170</manufacturerSrn>
    <authorisedRepresentativeName>E C REP LIMITED</authorisedRepresentativeName>
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    <emdnDescription>DERMATOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DLCAM-USB</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:16:42.881Z</lastUpdated>
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    <tradeName>DERMLITE</tradeName>
    <deviceName>DermLite GL Clip</deviceName>
    <manufacturerName>DermLite LLC</manufacturerName>
    <manufacturerSrn>US-MF-000005170</manufacturerSrn>
    <authorisedRepresentativeName>E C REP LIMITED</authorisedRepresentativeName>
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    <emdnDescription>DERMATOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GL1-1115</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:16:39.727Z</lastUpdated>
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    <udiDi>08500176512274</udiDi>
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    <tradeName>DERMLITE</tradeName>
    <deviceName>DL handyscope Battery</deviceName>
    <manufacturerName>DermLite LLC</manufacturerName>
    <manufacturerSrn>US-MF-000005170</manufacturerSrn>
    <authorisedRepresentativeName>E C REP LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003995</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12040108</emdnCode>
    <emdnDescription>DERMATOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FFH2B</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:16:39.574Z</lastUpdated>
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