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    <tradeName>Multi-Link™ Single-Patient-Use ECG Leadwire Set 3-LEAD, SNAP, IEC, 100 cm/39 in</tradeName>
    <deviceName>Multi-Link™ Single-Patient-Use ECG Leadwire Set</deviceName>
    <manufacturerName>AirLife Finland Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000001482</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>MDR 2017/745</legislation>
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    <reference>2052104-001</reference>
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    <lastUpdated>2026-07-15T19:59:53.610Z</lastUpdated>
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    <udiDi>06972820967358</udiDi>
    <basicUdiDi>B-06972820967358</basicUdiDi>
    <tradeName>SB0523</tradeName>
    <deviceName>IBP Cable</deviceName>
    <manufacturerName>Shenzhen SINO-K Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021157</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
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    <basicUdiDi>B-06972820963985</basicUdiDi>
    <tradeName>SG522DR-W</tradeName>
    <deviceName>ECG</deviceName>
    <manufacturerName>Shenzhen SINO-K Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021157</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
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    <reference>07-10-00</reference>
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    <udiDi>06972820963978</udiDi>
    <basicUdiDi>B-06972820963978</basicUdiDi>
    <tradeName>SG522DR-B</tradeName>
    <deviceName>ECG</deviceName>
    <manufacturerName>Shenzhen SINO-K Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021157</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
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    <legislation>MDD</legislation>
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    <emdnDescription>ELECTROCARDIOGRAPHS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>07-10-00</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T13:06:53.406Z</lastUpdated>
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    <udiDi>06972820963961</udiDi>
    <basicUdiDi>B-06972820963961</basicUdiDi>
    <tradeName>SG522DR-Y</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen SINO-K Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021157</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
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    <emdnDescription>ELECTROCARDIOGRAPHS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>07-10-00</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T13:06:52.603Z</lastUpdated>
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    <udiDi>06972820963954</udiDi>
    <basicUdiDi>B-06972820963954</basicUdiDi>
    <tradeName>SG522DR-G</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen SINO-K Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021157</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
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    <emdnDescription>ELECTROCARDIOGRAPHS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>07-10-00</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T13:06:47.814Z</lastUpdated>
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    <udiDi>06972820963947</udiDi>
    <basicUdiDi>B-06972820963947</basicUdiDi>
    <tradeName>SG522DR-R</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen SINO-K Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021157</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
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    <legislation>MDD</legislation>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>07-10-00</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T13:06:47.011Z</lastUpdated>
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    <udiDi>06972820963930</udiDi>
    <basicUdiDi>B-06972820963930</basicUdiDi>
    <tradeName>Patient Cable and Leadwires</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen SINO-K Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021157</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12050385</emdnCode>
    <emdnDescription>ELECTROCARDIOGRAPHS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>07-00-00</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T13:06:46.504Z</lastUpdated>
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    <udiDi>06972820963480</udiDi>
    <basicUdiDi>B-06972820963480</basicUdiDi>
    <tradeName>IBP Cable</tradeName>
    <deviceName>IBP Cable</deviceName>
    <manufacturerName>Shenzhen SINO-K Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021157</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12050385</emdnCode>
    <emdnDescription>ELECTROCARDIOGRAPHS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>07-10-00</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-06T13:06:41.417Z</lastUpdated>
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    <udiDi>06942108021911</udiDi>
    <basicUdiDi>B-06942108021911</basicUdiDi>
    <tradeName>IBP Cable</tradeName>
    <deviceName>IBP Cable</deviceName>
    <manufacturerName>Shenzhen SINO-K Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021157</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12050385</emdnCode>
    <emdnDescription>ELECTROCARDIOGRAPHS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>07-10-00</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-06T08:29:09.766Z</lastUpdated>
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    <udiDi>04931921120521</udiDi>
    <basicUdiDi>4931921MD10015BJ</basicUdiDi>
    <tradeName>STANDARD ACCESSORY KIT NKE　YD-124D</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NIHON KOHDEN CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000019022</manufacturerSrn>
    <authorisedRepresentativeName>NIHON KOHDEN EUROPE GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010740</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12050385</emdnCode>
    <emdnDescription>ELECTROCARDIOGRAPHS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>YD-124D</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T16:07:55.480Z</lastUpdated>
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    <udiDi>04931921871324</udiDi>
    <basicUdiDi>4931921MD10015BJ</basicUdiDi>
    <tradeName>Chest Electrode φ3 (Silicon Rubber) NC-113D</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NIHON KOHDEN CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000019022</manufacturerSrn>
    <authorisedRepresentativeName>NIHON KOHDEN EUROPE GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010740</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12050385</emdnCode>
    <emdnDescription>ECG ELECTRODES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H043A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T16:07:54.585Z</lastUpdated>
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    <basicUdiDi>4931921MD10015BJ</basicUdiDi>
    <tradeName>FAST CLIP NC-143E</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NIHON KOHDEN CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000019022</manufacturerSrn>
    <authorisedRepresentativeName>NIHON KOHDEN EUROPE GmbH</authorisedRepresentativeName>
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    <riskClass>Sınıf I</riskClass>
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    <emdnCode>Z12050385</emdnCode>
    <emdnDescription>ELECTROCARDIOGRAPHS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H068A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T16:07:54.570Z</lastUpdated>
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    <basicUdiDi>4931921MD10015BJ</basicUdiDi>
    <tradeName>FAST CLIP φ4 NC-144E</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NIHON KOHDEN CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000019022</manufacturerSrn>
    <authorisedRepresentativeName>NIHON KOHDEN EUROPE GmbH</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>H068B</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T16:07:54.552Z</lastUpdated>
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    <basicUdiDi>4931921MD10015BJ</basicUdiDi>
    <tradeName>CHEST ELECTRODE CHILD WITH LOGO NC-123D</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NIHON KOHDEN CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000019022</manufacturerSrn>
    <authorisedRepresentativeName>NIHON KOHDEN EUROPE GmbH</authorisedRepresentativeName>
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    <emdnCode>Z12050385</emdnCode>
    <emdnDescription>ECG ELECTRODES</emdnDescription>
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    <reference>H042C</reference>
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    <lastUpdated>2026-07-05T16:07:54.073Z</lastUpdated>
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    <basicUdiDi>4931921MD10015BJ</basicUdiDi>
    <tradeName>BR-201DA 12-lead set BR-201DA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NIHON KOHDEN CORPORATION</manufacturerName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>KA013</reference>
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    <basicUdiDi>4931921MD10015BJ</basicUdiDi>
    <tradeName>BR-201D chest lead C1 (1.2M) BR-201D</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NIHON KOHDEN CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000019022</manufacturerSrn>
    <authorisedRepresentativeName>NIHON KOHDEN EUROPE GmbH</authorisedRepresentativeName>
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    <emdnDescription>ELECTROCARDIOGRAPHS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
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    <manufacturerName>NIHON KOHDEN CORPORATION</manufacturerName>
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    <deviceName></deviceName>
    <manufacturerName>NIHON KOHDEN CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000019022</manufacturerSrn>
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    <emdnDescription>ELECTROCARDIOGRAPHS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KA02A</reference>
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    <deviceName></deviceName>
    <manufacturerName>NIHON KOHDEN CORPORATION</manufacturerName>
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    <emdnDescription>ELECTROCARDIOGRAPHS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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