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<eudamedExport entity="devices">
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    <tradeName>XCEL Detachment Controller</tradeName>
    <deviceName>XCEL Detachment Controller</deviceName>
    <manufacturerName>BALT USA LLC</manufacturerName>
    <manufacturerSrn>US-MF-000008651</manufacturerSrn>
    <authorisedRepresentativeName>BALT EXTRUSION SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000042061</authorisedRepresentativeSrn>
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    <legislation>MDD</legislation>
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    <reference>XCEL</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-01T08:16:19.708Z</lastUpdated>
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    <basicUdiDi>B-00817111021257</basicUdiDi>
    <tradeName>00817111021257</tradeName>
    <deviceName>Polysmith 12.2</deviceName>
    <manufacturerName>Neurotronics, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000030839</manufacturerSrn>
    <authorisedRepresentativeName>NIHON KOHDEN EUROPE GmbH</authorisedRepresentativeName>
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    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
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    <reference>PS12.2</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T08:01:28.372Z</lastUpdated>
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    <basicUdiDi>B-00817111021172</basicUdiDi>
    <tradeName>00817111021172</tradeName>
    <deviceName>Polysmith 12.0</deviceName>
    <manufacturerName>Neurotronics, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000030839</manufacturerSrn>
    <authorisedRepresentativeName>NIHON KOHDEN EUROPE GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010740</authorisedRepresentativeSrn>
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    <legislation>MDD</legislation>
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    <emdnDescription>POLYSOMNOGRAPHY INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PS12.0</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T08:01:24.731Z</lastUpdated>
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    <udiDi>00817111020335</udiDi>
    <basicUdiDi>B-00817111020335</basicUdiDi>
    <tradeName>00817111020335</tradeName>
    <deviceName>Sphinx HB710 Head Box</deviceName>
    <manufacturerName>Neurotronics, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000030839</manufacturerSrn>
    <authorisedRepresentativeName>NIHON KOHDEN EUROPE GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010740</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
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    <emdnDescription>POLYSOMNOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HB710</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T08:01:23.728Z</lastUpdated>
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  <row>
    <udiDi>00817111020205</udiDi>
    <basicUdiDi>B-00817111020205</basicUdiDi>
    <tradeName>00817111020205</tradeName>
    <deviceName>Sphinx CU710 Control Unit</deviceName>
    <manufacturerName>Neurotronics, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000030839</manufacturerSrn>
    <authorisedRepresentativeName>NIHON KOHDEN EUROPE GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010740</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12100501</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CU710</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T08:01:22.782Z</lastUpdated>
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  <row>
    <udiDi>09342451001054</udiDi>
    <basicUdiDi>9342451NEUVO3K</basicUdiDi>
    <tradeName>09342451001054</tradeName>
    <deviceName>Neuvo System Unit</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>Z12100302</emdnCode>
    <emdnDescription>ELECTROENCEPHALOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9022-0004-01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T21:43:46.064Z</lastUpdated>
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  <row>
    <udiDi>09120112971102</udiDi>
    <basicUdiDi>91201129710069</basicUdiDi>
    <tradeName>VIVO</tradeName>
    <deviceName>VIVO</deviceName>
    <manufacturerName>AURIMOD GmbH</manufacturerName>
    <manufacturerSrn>AT-MF-000000433</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12101106</emdnCode>
    <emdnDescription>NEUROLOGICAL STIMULATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-31T21:40:04.981Z</lastUpdated>
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  <row>
    <udiDi>08881300509026</udiDi>
    <basicUdiDi>88813005090265Y</basicUdiDi>
    <tradeName>Nerve Locating System System</tradeName>
    <deviceName>Nerve Locating System System</deviceName>
    <manufacturerName>NCCMedical Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000031924</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z121002</emdnCode>
    <emdnDescription>NERVOUS SYSTEM MONITORING SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ExcMT-IONM-HDPro,ExcMT-IONM-HD,ExcMT-IONM-HSPro, ExcMT-IONM-HS</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-31T21:08:42.192Z</lastUpdated>
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    <udiDi>08881300509019</udiDi>
    <basicUdiDi>888130050901963</basicUdiDi>
    <tradeName>EMG-EP Neurodiagnostic System</tradeName>
    <deviceName>EMG-EP Neurodiagnostic System</deviceName>
    <manufacturerName>NCCMedical Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000031924</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12100401</emdnCode>
    <emdnDescription>ELECTROMYOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ExcMT-EMG/EP-F, ExcMT-EMG-F, ExcMT-EMG/EP-D, ExcMT-EMG-D, ExcMT-EMG/EP-C</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-31T21:08:41.410Z</lastUpdated>
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  <row>
    <udiDi>08881300509002</udiDi>
    <basicUdiDi>88813005090025J</basicUdiDi>
    <tradeName>Electroencephalography (EEG) System</tradeName>
    <deviceName>Electroencephalography (EEG) System</deviceName>
    <manufacturerName>NCCMedical Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000031924</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12100302</emdnCode>
    <emdnDescription>ELECTROENCEPHALOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ExcMT-EEG-F, ExcMT-EEG-E</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-31T21:08:39.007Z</lastUpdated>
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  <row>
    <udiDi>00869732000166</udiDi>
    <basicUdiDi>869732000166JJ</basicUdiDi>
    <tradeName>00869732000166</tradeName>
    <deviceName>Persyst 15 EEG Review and Analysis Software</deviceName>
    <manufacturerName>Persyst Development LLC</manufacturerName>
    <manufacturerSrn>US-MF-000036728</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12100392</emdnCode>
    <emdnDescription>ELECTROENCEPHALOGRAPHY INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>None</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T20:26:54.041Z</lastUpdated>
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  <row>
    <udiDi>18436612824014</udiDi>
    <basicUdiDi>843661282000MF08AdapterP8</basicUdiDi>
    <tradeName>Touchproof Adapter 20</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Neuroelectrics Barcelona, S.L.U.</manufacturerName>
    <manufacturerSrn>ES-MF-000033432</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12100380</emdnCode>
    <emdnDescription>ELECTROENCEPHALOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NE005WF-20-P.MD:EU</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-31T20:04:51.318Z</lastUpdated>
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    <udiDi>08437025622023</udiDi>
    <basicUdiDi>8437025622ANKYRASMSPM3</basicUdiDi>
    <tradeName>Ankyras</tradeName>
    <deviceName>Ankyras</deviceName>
    <manufacturerName>Mentice Spain S.L</manufacturerName>
    <manufacturerSrn>ES-MF-000036826</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12109082</emdnCode>
    <emdnDescription>VARIOUS NEUROLOGY AND NEUROSURGERY INSTRUMENTS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6.0</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:58:40.159Z</lastUpdated>
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    <udiDi>04250413410552</udiDi>
    <basicUdiDi>42504134SB-S_L8K</basicUdiDi>
    <tradeName>Shoulder belt- Size L</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SOMNOmedics AG</manufacturerName>
    <manufacturerSrn>DE-MF-000006921</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12100580</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NGA252</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:55:18.114Z</lastUpdated>
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    <udiDi>18436612824021</udiDi>
    <basicUdiDi>843661282000MF08AdapterP8</basicUdiDi>
    <tradeName>Touchproof Adapter 32</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Neuroelectrics Barcelona, S.L.U.</manufacturerName>
    <manufacturerSrn>ES-MF-000033432</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12100380</emdnCode>
    <emdnDescription>ELECTROENCEPHALOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NE005WF-32-P.MD:EU</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:49:28.723Z</lastUpdated>
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    <udiDi>18054242442356</udiDi>
    <basicUdiDi>803300326117000007P6</basicUdiDi>
    <tradeName>18054242442356</tradeName>
    <deviceName></deviceName>
    <manufacturerName>FIAB S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000005988</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12100480</emdnCode>
    <emdnDescription>ELECTROMYOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F8959/1</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:24:53.654Z</lastUpdated>
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    <basicUdiDi>803300326117000006P4</basicUdiDi>
    <tradeName>18054242441380</tradeName>
    <deviceName></deviceName>
    <manufacturerName>FIAB S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000005988</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12100380</emdnCode>
    <emdnDescription>ELECTROENCEPHALOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F8901/1</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:24:41.488Z</lastUpdated>
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    <udiDi>07290109222035</udiDi>
    <basicUdiDi>729010922AC21107M9</basicUdiDi>
    <tradeName>WatchPAT™ Central Plus Sensor</tradeName>
    <deviceName>Watch-PAT300</deviceName>
    <manufacturerName>Itamar Medical Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000012046</manufacturerSrn>
    <authorisedRepresentativeName>Arazy Group GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12100580</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AC3000100</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:00:07.743Z</lastUpdated>
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    <basicUdiDi>729010922AC20003LM</basicUdiDi>
    <tradeName>WatchPAT™ Tamper Proof Bracelet</tradeName>
    <deviceName>Tamper-Proof Bracelet for WatchPAT</deviceName>
    <manufacturerName>Itamar Medical Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000012046</manufacturerSrn>
    <authorisedRepresentativeName>Arazy Group GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007685</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12100580</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AC2000300</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:56:13.048Z</lastUpdated>
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    <tradeName>WatchPAT™ONE</tradeName>
    <deviceName>WatchPAT ONE</deviceName>
    <manufacturerName>Itamar Medical Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000012046</manufacturerSrn>
    <authorisedRepresentativeName>Arazy Group GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12100501</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AC2110800</reference>
    <placedOnMarketCountry>Latvia</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:56:12.248Z</lastUpdated>
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