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    <basicUdiDi>0850010298COR500MG</basicUdiDi>
    <tradeName>CORE 500 Digital Stethoscope - Earpiece</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Eko Health, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000034386</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>CAC500_FOW</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:47:31.627Z</lastUpdated>
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    <udiDi>00850010298955</udiDi>
    <basicUdiDi>0850010298COR500MG</basicUdiDi>
    <tradeName>CORE 500 Digital Stethoscope - Chestpiece</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Eko Health, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000034386</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PHONENDOSCOPES AND STETHOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>COR500_ROG</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:47:31.616Z</lastUpdated>
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    <udiDi>00850010298962</udiDi>
    <basicUdiDi>0850010298COR500MG</basicUdiDi>
    <tradeName>CORE 500 Digital Stethoscope - Earpiece</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Eko Health, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000034386</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PHONENDOSCOPES AND STETHOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CAC500_ROG</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:47:31.594Z</lastUpdated>
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    <udiDi>00850079955004</udiDi>
    <basicUdiDi>0850010298COR500MG</basicUdiDi>
    <tradeName>CORE 500 Digital Stethoscope - Earpiece</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Eko Health, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000034386</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PHONENDOSCOPES AND STETHOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CAC500_FCB</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:43:32.610Z</lastUpdated>
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  <row>
    <udiDi>00850079955011</udiDi>
    <basicUdiDi>0850010298COR500MG</basicUdiDi>
    <tradeName>CORE 500 Digital Stethoscope - Earpiece</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Eko Health, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000034386</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PHONENDOSCOPES AND STETHOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CAC500_FBY</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:43:32.593Z</lastUpdated>
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  <row>
    <udiDi>00850079955028</udiDi>
    <basicUdiDi>0850010298COR500MG</basicUdiDi>
    <tradeName>CORE 500 Digital Stethoscope - Earpiece</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Eko Health, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000034386</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PHONENDOSCOPES AND STETHOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CAC500_FRP</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:43:32.570Z</lastUpdated>
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    <udiDi>00850079955035</udiDi>
    <basicUdiDi>0850010298COR500MG</basicUdiDi>
    <tradeName>CORE 500 Digital Stethoscope - Earpiece</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Eko Health, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000034386</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PHONENDOSCOPES AND STETHOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CAC500_FOT</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:43:32.537Z</lastUpdated>
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  <row>
    <udiDi>00863609000334</udiDi>
    <basicUdiDi>0850010298COR500MG</basicUdiDi>
    <tradeName>CORE 500 Digital Stethoscope - Eko App</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Eko Health, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000034386</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PHONENDOSCOPES AND STETHOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>iOS v5.x</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T20:15:24.981Z</lastUpdated>
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    <udiDi>00863609000341</udiDi>
    <basicUdiDi>0850010298COR500MG</basicUdiDi>
    <tradeName>CORE 500 Digital Stethoscope - Eko App</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Eko Health, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000034386</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PHONENDOSCOPES AND STETHOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Android v5.x</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T20:15:24.956Z</lastUpdated>
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  <row>
    <udiDi>00850010298009</udiDi>
    <basicUdiDi>B-00850010298009</basicUdiDi>
    <tradeName>Eko CORE Digital Attachment</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Eko Health, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000034386</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PHONENDOSCOPES AND STETHOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>COR200</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:24:11.249Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850010298016</udiDi>
    <basicUdiDi>B-00850010298016</basicUdiDi>
    <tradeName>Eko CORE Digital Stethoscope</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Eko Health, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000034386</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PHONENDOSCOPES AND STETHOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>COR201</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:24:11.236Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850010298030</udiDi>
    <basicUdiDi>B-00850010298030</basicUdiDi>
    <tradeName>00850010298030</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Eko Health, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000034386</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VITAL SIGNS MONITORING INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EAS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:24:11.207Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850010298160</udiDi>
    <basicUdiDi>0850010298COR500MG</basicUdiDi>
    <tradeName>CORE 500 Digital Stethoscope - Chestpiece</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Eko Health, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000034386</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PHONENDOSCOPES AND STETHOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>COR500</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:24:11.196Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850010298177</udiDi>
    <basicUdiDi>0850010298COR500MG</basicUdiDi>
    <tradeName>CORE 500 Digital Stethoscope - Earpiece</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Eko Health, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000034386</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PHONENDOSCOPES AND STETHOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CAC500</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:24:11.185Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850010298245</udiDi>
    <basicUdiDi>0850010298COR500MG</basicUdiDi>
    <tradeName>CORE 500 Digital Stethoscope - Earpiece</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Eko Health, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000034386</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PHONENDOSCOPES AND STETHOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CAC500_FBL</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:24:11.173Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850010298252</udiDi>
    <basicUdiDi>0850010298COR500MG</basicUdiDi>
    <tradeName>CORE 500 Digital Stethoscope - Earpiece</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Eko Health, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000034386</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PHONENDOSCOPES AND STETHOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CAC500_FGR</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:24:11.161Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850010298269</udiDi>
    <basicUdiDi>0850010298COR500MG</basicUdiDi>
    <tradeName>CORE 500 Digital Stethoscope - Earpiece</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Eko Health, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000034386</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PHONENDOSCOPES AND STETHOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CAC500_FMA</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:24:11.130Z</lastUpdated>
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    <udiDi>00850010298276</udiDi>
    <basicUdiDi>0850010298COR500MG</basicUdiDi>
    <tradeName>CORE 500 Digital Stethoscope - Earpiece</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Eko Health, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000034386</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PHONENDOSCOPES AND STETHOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CAC500_FSA</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:24:11.110Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850010298283</udiDi>
    <basicUdiDi>0850010298COR500MG</basicUdiDi>
    <tradeName>CORE 500 Digital Stethoscope - Chestpiece</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Eko Health, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000034386</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PHONENDOSCOPES AND STETHOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>COR500_Black</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:24:11.096Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850010298306</udiDi>
    <basicUdiDi>0850010298COR500MG</basicUdiDi>
    <tradeName>CORE 500 Digital Stethoscope - Earpiece</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Eko Health, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000034386</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PHONENDOSCOPES AND STETHOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CAC500_FRB</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:24:11.083Z</lastUpdated>
  </row>
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