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<eudamedExport entity="devices">
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    <udiDi>00810084333525</udiDi>
    <basicUdiDi>081008433799549AW</basicUdiDi>
    <tradeName>XCELTRAX® ANKLE REPLACEMENT LINER</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Span Link International, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000012261</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PASSIVE ANKLE-FOOT ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>79-95568-1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T06:59:26.317Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810084333693</udiDi>
    <basicUdiDi>08100843317000331901UT</basicUdiDi>
    <tradeName>Clavicular Support</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Span Link International, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000012261</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ORTHOSES, UPPER EXTREMITY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>17000331901</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T06:59:26.290Z</lastUpdated>
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    <udiDi>00810084333709</udiDi>
    <basicUdiDi>08100843317000331901UT</basicUdiDi>
    <tradeName>Clavicular Support</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Span Link International, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000012261</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ORTHOSES, UPPER EXTREMITY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>17000331902</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T06:59:26.256Z</lastUpdated>
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  <row>
    <udiDi>00810084333716</udiDi>
    <basicUdiDi>08100843317000331901UT</basicUdiDi>
    <tradeName>Clavicular Support</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Span Link International, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000012261</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ORTHOSES, UPPER EXTREMITY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>17000331903</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T06:59:26.226Z</lastUpdated>
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  <row>
    <udiDi>00810084333723</udiDi>
    <basicUdiDi>08100843317000331901UT</basicUdiDi>
    <tradeName>Clavicular Support</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Span Link International, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000012261</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ORTHOSES, UPPER EXTREMITY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>17000331904</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T06:59:26.193Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810084333730</udiDi>
    <basicUdiDi>08100843317000331901UT</basicUdiDi>
    <tradeName>Clavicular Support</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Span Link International, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000012261</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ORTHOSES, UPPER EXTREMITY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>17000331904</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T06:59:26.162Z</lastUpdated>
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  <row>
    <udiDi>00810084333747</udiDi>
    <basicUdiDi>08100843317000331901UT</basicUdiDi>
    <tradeName>Clavicular Support</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Span Link International, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000012261</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ORTHOSES, UPPER EXTREMITY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>17000331904</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T06:59:26.119Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810173653022</udiDi>
    <basicUdiDi>81017365OG-G2604E</basicUdiDi>
    <tradeName>Multiplex Fluorescent Analyzer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Healgen Scientific Limited Liability Company</manufacturerName>
    <manufacturerSrn>US-MF-000018839</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OG-G260</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-08T06:50:08.676Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810173654708</udiDi>
    <basicUdiDi>81649002OG-H10189</basicUdiDi>
    <tradeName>Mini Immunofluorescence Analyzer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Healgen Scientific Limited Liability Company</manufacturerName>
    <manufacturerSrn>US-MF-000018839</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OG-H101</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-08T06:50:08.635Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810173655149</udiDi>
    <basicUdiDi>81649002Mplex-M100RS</basicUdiDi>
    <tradeName>00810173655149</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Healgen Scientific Limited Liability Company</manufacturerName>
    <manufacturerSrn>US-MF-000018839</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>FLOW CYTOMETRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M-FLA-201-01</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-08T06:50:08.609Z</lastUpdated>
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  <row>
    <udiDi>00810173655187</udiDi>
    <basicUdiDi>81649002Mplex-M100RS</basicUdiDi>
    <tradeName>00810173655187</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Healgen Scientific Limited Liability Company</manufacturerName>
    <manufacturerSrn>US-MF-000018839</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>FLOW CYTOMETRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M-FLA-202-01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T06:50:08.570Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810173656818</udiDi>
    <basicUdiDi>B-00810173656818</basicUdiDi>
    <tradeName>In vitro Diagnostic Kit for Creatine Kinase-MB (Chemiluminescence Assay)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Healgen Scientific Limited Liability Company</manufacturerName>
    <manufacturerSrn>US-MF-000018839</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CREATINE KINASE ISOENZYMES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1CKMBB01</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-08T06:50:08.541Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810173656825</udiDi>
    <basicUdiDi>B-00810173656825</basicUdiDi>
    <tradeName>In vitro Diagnostic Kit for Creatine Kinase-MB (Chemiluminescence Assay)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Healgen Scientific Limited Liability Company</manufacturerName>
    <manufacturerSrn>US-MF-000018839</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CREATINE KINASE ISOENZYMES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1CKMBB02</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-08T06:50:08.505Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810173656832</udiDi>
    <basicUdiDi>B-00810173656832</basicUdiDi>
    <tradeName>In vitro Diagnostic Kit for High sensitivity Troponin T (Chemiluminescence Assay)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Healgen Scientific Limited Liability Company</manufacturerName>
    <manufacturerSrn>US-MF-000018839</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>TROPONIN I/T</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1CTNTB01</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-08T06:50:08.474Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810173656849</udiDi>
    <basicUdiDi>B-00810173656849</basicUdiDi>
    <tradeName>In vitro Diagnostic Kit for High sensitivity Troponin T (Chemiluminescence Assay)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Healgen Scientific Limited Liability Company</manufacturerName>
    <manufacturerSrn>US-MF-000018839</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>TROPONIN I/T</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1CTNTB02</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-08T06:50:08.446Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810173656856</udiDi>
    <basicUdiDi>B-00810173656856</basicUdiDi>
    <tradeName>In vitro Diagnostic Kit for Myoglobin (Chemiluminescence Assay)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Healgen Scientific Limited Liability Company</manufacturerName>
    <manufacturerSrn>US-MF-000018839</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>MYOGLOBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1MYOB01</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-08T06:50:08.420Z</lastUpdated>
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  <row>
    <udiDi>00810173656863</udiDi>
    <basicUdiDi>B-00810173656863</basicUdiDi>
    <tradeName>In vitro Diagnostic Kit for Myoglobin (Chemiluminescence Assay)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Healgen Scientific Limited Liability Company</manufacturerName>
    <manufacturerSrn>US-MF-000018839</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>MYOGLOBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1MYOB02</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-08T06:50:08.396Z</lastUpdated>
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    <udiDi>00810173656870</udiDi>
    <basicUdiDi>B-00810173656870</basicUdiDi>
    <tradeName>Quantitative Analysis Kit for Three Tumor Markers (Flowcytometry Fluorescence Method)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Healgen Scientific Limited Liability Company</manufacturerName>
    <manufacturerSrn>US-MF-000018839</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1TM3B01</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-08T06:50:08.371Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810173656887</udiDi>
    <basicUdiDi>B-00810173656887</basicUdiDi>
    <tradeName>Quantitative Analysis Kit for Seven Tumor Markers (Flowcytometry Fluorescence Method)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Healgen Scientific Limited Liability Company</manufacturerName>
    <manufacturerSrn>US-MF-000018839</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1TM7B01</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-08T06:50:08.350Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810173656894</udiDi>
    <basicUdiDi>B-00810173656894</basicUdiDi>
    <tradeName>Quantitative Analysis Kit for Six Tumor Markers (Flowcytometry Fluorescence Method)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Healgen Scientific Limited Liability Company</manufacturerName>
    <manufacturerSrn>US-MF-000018839</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1TM6B01</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-08T06:50:08.331Z</lastUpdated>
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