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    <udiDi>00857688007001</udiDi>
    <basicUdiDi>B-00857688007001</basicUdiDi>
    <tradeName>remede System</tradeName>
    <deviceName>remedē® Implantable Pulse Generator (IPG)</deviceName>
    <manufacturerName>ZOLL Respicardia, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000023953</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J0206</emdnCode>
    <emdnDescription>FRENIC NERVE IMPLANTABLE NEUROSTIMULATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:33:45.811Z</lastUpdated>
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    <udiDi>D-002581LQ</udiDi>
    <basicUdiDi>B-002581LQ</basicUdiDi>
    <tradeName>Evoke®  Clinical Data Viewer</tradeName>
    <deviceName>Evoke®  Clinical Data Viewer</deviceName>
    <manufacturerName>Saluda Medical Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000010522</manufacturerSrn>
    <authorisedRepresentativeName>MedR-AR Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000120</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J020792</emdnCode>
    <emdnDescription>NEUROSTIMULATORS PROGRAMMERS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>002581</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T13:06:16.897Z</lastUpdated>
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    <udiDi>D-000897M8</udiDi>
    <basicUdiDi>B-000897M8</basicUdiDi>
    <tradeName>Evoke® Firmware Upgrade Application (FUA)</tradeName>
    <deviceName>Evoke® Firmware Upgrade Application (FUA)</deviceName>
    <manufacturerName>Saluda Medical Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000010522</manufacturerSrn>
    <authorisedRepresentativeName>MedR-AR Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000120</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J020792</emdnCode>
    <emdnDescription>NEUROSTIMULATORS PROGRAMMERS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>000897</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T06:10:36.233Z</lastUpdated>
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    <udiDi>D-000870LL</udiDi>
    <basicUdiDi>B-000870LL</basicUdiDi>
    <tradeName>Evoke®  Clinical Programming Application (CPA)</tradeName>
    <deviceName>Evoke® Clinical Programming Application (CPA)</deviceName>
    <manufacturerName>Saluda Medical Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000010522</manufacturerSrn>
    <authorisedRepresentativeName>MedR-AR Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000120</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J020792</emdnCode>
    <emdnDescription>NEUROSTIMULATORS PROGRAMMERS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>000870</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T06:10:34.638Z</lastUpdated>
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    <udiDi>06971047460161</udiDi>
    <basicUdiDi>697104746MRS2016QU</basicUdiDi>
    <tradeName>06971047460161</tradeName>
    <deviceName>Training Software For Visual Function Therapy</deviceName>
    <manufacturerName>Guangzhou Shijing Medical Software Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032261</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>J020792</emdnCode>
    <emdnDescription>NEUROSTIMULATORS PROGRAMMERS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SJ-MRS2016</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T08:30:13.832Z</lastUpdated>
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    <udiDi>06971047460154</udiDi>
    <basicUdiDi>697104746JRS2021P2</basicUdiDi>
    <tradeName>06971047460154</tradeName>
    <deviceName>Training Software For Visual Function Therapy</deviceName>
    <manufacturerName>Guangzhou Shijing Medical Software Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032261</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>J020792</emdnCode>
    <emdnDescription>NEUROSTIMULATORS PROGRAMMERS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SJ-JRS2021</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T08:30:13.022Z</lastUpdated>
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    <udiDi>06971047460147</udiDi>
    <basicUdiDi>697104746RS-WL2015HZ</basicUdiDi>
    <tradeName>06971047460147</tradeName>
    <deviceName>Training Software For Visual Function Therapy</deviceName>
    <manufacturerName>Guangzhou Shijing Medical Software Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032261</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>J020792</emdnCode>
    <emdnDescription>NEUROSTIMULATORS PROGRAMMERS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SJ-RS-WL2015</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T08:30:09.018Z</lastUpdated>
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    <udiDi>05407008590444</udiDi>
    <basicUdiDi>540700859MOT00N9B</basicUdiDi>
    <tradeName>SC-8080-4 - Electrodes for Compex CoreBelt Series, 80X80mm, 4pcs</tradeName>
    <deviceName>MOTRON-NOCON</deviceName>
    <manufacturerName>Motron NV</manufacturerName>
    <manufacturerSrn>BE-MF-000024522</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>J020785</emdnCode>
    <emdnDescription>NEUROSTIMULATORS PROGRAMMERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SC-8080-4</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-02T00:49:02.652Z</lastUpdated>
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    <udiDi>05407008590062</udiDi>
    <basicUdiDi>540700859MOT00W9V</basicUdiDi>
    <tradeName>FW-32R-4 - TENS-EMS Electrodes, 2mm Pin Connector, 32mm Round, 4pcs</tradeName>
    <deviceName>MOTRON-WIRED</deviceName>
    <manufacturerName>Motron NV</manufacturerName>
    <manufacturerSrn>BE-MF-000024522</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>J020785</emdnCode>
    <emdnDescription>NEUROSTIMULATORS PROGRAMMERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FW-32R-4</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-02T00:49:01.877Z</lastUpdated>
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    <udiDi>05407008590024</udiDi>
    <basicUdiDi>540700859MOT00S9M</basicUdiDi>
    <tradeName>SS-5050-4 - TENS-EMS Electrodes, 3,75mm Snap Connector, 50X50mm, 4pcs</tradeName>
    <deviceName>MOTRON-SNAP</deviceName>
    <manufacturerName>Motron NV</manufacturerName>
    <manufacturerSrn>BE-MF-000024522</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>J020785</emdnCode>
    <emdnDescription>NEUROSTIMULATORS PROGRAMMERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SS-5050-4</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-02T00:49:01.056Z</lastUpdated>
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    <udiDi>04260479770781</udiDi>
    <basicUdiDi>426047977022426</basicUdiDi>
    <tradeName>EASEE System</tradeName>
    <deviceName>EASEE System</deviceName>
    <manufacturerName>Precisis Gesellschaft mit beschränkter Haftung</manufacturerName>
    <manufacturerSrn>DE-MF-000016826</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>J020199</emdnCode>
    <emdnDescription>CEREBRAL IMPLANTABLE NEUROSTIMULATORS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ESC003</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T19:39:55.574Z</lastUpdated>
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    <udiDi>06959809601892</udiDi>
    <basicUdiDi>B-06959809601892</basicUdiDi>
    <tradeName>Test Stimulator</tradeName>
    <deviceName>Test Stimulator</deviceName>
    <manufacturerName>Beijing PINS Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000022865</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J020199</emdnCode>
    <emdnDescription>CEREBRAL IMPLANTABLE NEUROSTIMULATORS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>T901</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-29T16:21:29.046Z</lastUpdated>
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    <udiDi>06959809601885</udiDi>
    <basicUdiDi>B-06959809601885</basicUdiDi>
    <tradeName>Clinician Programmer</tradeName>
    <deviceName>Clinician Programmer</deviceName>
    <manufacturerName>Beijing PINS Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000022865</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J020199</emdnCode>
    <emdnDescription>CEREBRAL IMPLANTABLE NEUROSTIMULATORS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PSM1001</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-29T16:21:27.837Z</lastUpdated>
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    <udiDi>06959809601878</udiDi>
    <basicUdiDi>B-06959809601878</basicUdiDi>
    <tradeName>Patient Programmer Recharger</tradeName>
    <deviceName>Patient Programmer Recharger</deviceName>
    <manufacturerName>Beijing PINS Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000022865</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J020199</emdnCode>
    <emdnDescription>CEREBRAL IMPLANTABLE NEUROSTIMULATORS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R801</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-29T16:21:26.639Z</lastUpdated>
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    <udiDi>06959809601861</udiDi>
    <basicUdiDi>B-06959809601861</basicUdiDi>
    <tradeName>Patient Programmer</tradeName>
    <deviceName>Patient Programmer</deviceName>
    <manufacturerName>Beijing PINS Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000022865</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J020199</emdnCode>
    <emdnDescription>CEREBRAL IMPLANTABLE NEUROSTIMULATORS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C701</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-29T16:21:25.447Z</lastUpdated>
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    <udiDi>06959809601854</udiDi>
    <basicUdiDi>B-06959809601854</basicUdiDi>
    <tradeName>Test Extension Kit for Deep Brain Stimulation</tradeName>
    <deviceName>Test Extension Kit for Deep Brain Stimulation</deviceName>
    <manufacturerName>Beijing PINS Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000022865</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J020102</emdnCode>
    <emdnDescription>DEEP BRAIN STIMULATION (DBS) LEADS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TE01</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-29T16:21:19.431Z</lastUpdated>
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    <udiDi>06959809601847</udiDi>
    <basicUdiDi>B-06959809601847</basicUdiDi>
    <tradeName>Implantable Lead Kit for Deep Brain Stimulation</tradeName>
    <deviceName>Implantable Lead Kit for Deep Brain Stimulation</deviceName>
    <manufacturerName>Beijing PINS Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000022865</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J020102</emdnCode>
    <emdnDescription>DEEP BRAIN STIMULATION (DBS) LEADS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>L302S</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-29T16:21:18.239Z</lastUpdated>
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    <udiDi>06959809601830</udiDi>
    <basicUdiDi>B-06959809601830</basicUdiDi>
    <tradeName>Implantable Lead Kit for Deep Brain Stimulation</tradeName>
    <deviceName>Implantable Lead Kit for Deep Brain Stimulation</deviceName>
    <manufacturerName>Beijing PINS Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000022865</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J020102</emdnCode>
    <emdnDescription>DEEP BRAIN STIMULATION (DBS) LEADS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>L301S</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-29T16:21:17.027Z</lastUpdated>
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    <udiDi>06959809601823</udiDi>
    <basicUdiDi>B-06959809601823</basicUdiDi>
    <tradeName>Implantable Lead Kit for Deep Brain Stimulation</tradeName>
    <deviceName>Implantable Lead Kit for Deep Brain Stimulation</deviceName>
    <manufacturerName>Beijing PINS Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000022865</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J020102</emdnCode>
    <emdnDescription>DEEP BRAIN STIMULATION (DBS) LEADS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>L302</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-29T16:21:15.833Z</lastUpdated>
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    <udiDi>06959809601816</udiDi>
    <basicUdiDi>B-06959809601816</basicUdiDi>
    <tradeName>Implantable Lead Kit for Deep Brain Stimulation</tradeName>
    <deviceName>Implantable Lead Kit for Deep Brain Stimulation</deviceName>
    <manufacturerName>Beijing PINS Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000022865</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J020102</emdnCode>
    <emdnDescription>DEEP BRAIN STIMULATION (DBS) LEADS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>L301</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-29T16:21:09.832Z</lastUpdated>
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