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    <basicUdiDi>08453570HE0053NS2C</basicUdiDi>
    <tradeName>10845357042771</tradeName>
    <deviceName>Helix Elite™ Molecular Standards: Inactivated Standard</deviceName>
    <manufacturerName>Microbiologics, INC.</manufacturerName>
    <manufacturerSrn>US-MF-000000466</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080801</emdnCode>
    <emdnDescription>BACTERIOLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>[HE0053NS] Helix Elite™ Molecular Standards Methicillin-Resistant Staphylococcus aureus (MRSA) Inactivated Swab</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T02:53:41.741Z</lastUpdated>
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    <udiDi>10845357042672</udiDi>
    <basicUdiDi>08453570HE0052NYZ</basicUdiDi>
    <tradeName>10845357042672</tradeName>
    <deviceName>Helix Elite™ Molecular Standards: Inactivated Standard</deviceName>
    <manufacturerName>Microbiologics, INC.</manufacturerName>
    <manufacturerSrn>US-MF-000000466</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080801</emdnCode>
    <emdnDescription>BACTERIOLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>[HE0052N] Helix Elite™ Molecular Standards Inactivated Borrelia burgdorferi</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T02:53:40.936Z</lastUpdated>
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    <udiDi>10845357042788</udiDi>
    <basicUdiDi>08453570HE0054NS2H</basicUdiDi>
    <tradeName>10845357042788</tradeName>
    <deviceName>Helix Elite™ Molecular Standards: Inactivated Standard</deviceName>
    <manufacturerName>Microbiologics, INC.</manufacturerName>
    <manufacturerSrn>US-MF-000000466</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080801</emdnCode>
    <emdnDescription>BACTERIOLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>[HE0054NS] Helix Elite™ Molecular Standards Methicillin-Susceptible Staphylococcus aureus (MSSA) Inactivated Swab</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T02:53:39.339Z</lastUpdated>
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    <udiDi>10845357042191</udiDi>
    <basicUdiDi>08453570HE0045NZ5</basicUdiDi>
    <tradeName>10845357042191</tradeName>
    <deviceName>Helix Elite™ Molecular Standards: Inactivated Standard</deviceName>
    <manufacturerName>Microbiologics, INC.</manufacturerName>
    <manufacturerSrn>US-MF-000000466</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080801</emdnCode>
    <emdnDescription>BACTERIOLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>[HE0045N] Helix Elite™ Molecular Standards Inactivated Chlamydia trachomatis/ Neisseria gonorrhoeae (CT/NG)</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T02:53:36.974Z</lastUpdated>
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    <udiDi>10845357042153</udiDi>
    <basicUdiDi>08453570HE0041NYR</basicUdiDi>
    <tradeName>10845357042153</tradeName>
    <deviceName>Helix Elite™ Molecular Standards: Inactivated Standard</deviceName>
    <manufacturerName>Microbiologics, INC.</manufacturerName>
    <manufacturerSrn>US-MF-000000466</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080801</emdnCode>
    <emdnDescription>BACTERIOLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>[HE0041N] Helix Elite™ Molecular Standards Inactivated Neisseria gonorrhoeae Strain GL0071</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T02:53:19.258Z</lastUpdated>
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  <row>
    <udiDi>10845357042092</udiDi>
    <basicUdiDi>08453570HE0035NYY</basicUdiDi>
    <tradeName>10845357042092</tradeName>
    <deviceName>Helix Elite™ Molecular Standards: Inactivated Standard</deviceName>
    <manufacturerName>Microbiologics, INC.</manufacturerName>
    <manufacturerSrn>US-MF-000000466</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080801</emdnCode>
    <emdnDescription>BACTERIOLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>[HE0035N] Helix Elite™ Molecular Standards Inactivated Chlamydia trachomatis Strain LGV-2-434</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T02:53:08.148Z</lastUpdated>
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    <udiDi>10845357042085</udiDi>
    <basicUdiDi>08453570HE0034NYV</basicUdiDi>
    <tradeName>10845357042085</tradeName>
    <deviceName>Helix Elite™ Molecular Standards: Inactivated Standard</deviceName>
    <manufacturerName>Microbiologics, INC.</manufacturerName>
    <manufacturerSrn>US-MF-000000466</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080801</emdnCode>
    <emdnDescription>BACTERIOLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>[HE0034N] Helix Elite™ Molecular Standards Inactivated Chlamydia pneumoniae CWL-029</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T02:53:07.383Z</lastUpdated>
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    <udiDi>D-GCSTR-PN2Q4</udiDi>
    <basicUdiDi>B-GCSTR-PN2Q4</basicUdiDi>
    <tradeName>Strep A Antigen Control Kit</tradeName>
    <deviceName>Strep A Antigen Control Kit</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105080801</emdnCode>
    <emdnDescription>BACTERIOLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCSTR-PN2</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:32:15.513Z</lastUpdated>
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    <udiDi>D-GCSTR-PN2HGTH</udiDi>
    <basicUdiDi>B-GCSTR-PN2HGTH</basicUdiDi>
    <tradeName>Strep A Antigen Control Kit</tradeName>
    <deviceName>Strep A Antigen Control Kit</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>IVDD</legislation>
    <emdnCode>W0105080801</emdnCode>
    <emdnDescription>BACTERIOLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCSTR-PN2</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:32:14.964Z</lastUpdated>
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  <row>
    <udiDi>D-GCHP-PN2K6</udiDi>
    <basicUdiDi>B-GCHP-PN2K6</basicUdiDi>
    <tradeName>H. pylori Ag Control Kit</tradeName>
    <deviceName>H. pylori Ag Control Kit</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105080801</emdnCode>
    <emdnDescription>BACTERIOLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCHP-PN2</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:28:19.811Z</lastUpdated>
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  <row>
    <udiDi>D-CC848RN</udiDi>
    <basicUdiDi>B-CC848RN</basicUdiDi>
    <tradeName>M. Pneumoniae IgM Control</tradeName>
    <deviceName>M. Pneumoniae IgM Control</deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105080801</emdnCode>
    <emdnDescription>BACTERIOLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CC848</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:57:15.030Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CC847RL</udiDi>
    <basicUdiDi>B-CC847RL</basicUdiDi>
    <tradeName>M. Pneumoniae IgG Control</tradeName>
    <deviceName>M. Pneumoniae IgG Control</deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105080801</emdnCode>
    <emdnDescription>BACTERIOLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CC847</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:57:14.276Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CC820QY</udiDi>
    <basicUdiDi>B-CC820QY</basicUdiDi>
    <tradeName>Procalcitonin Control</tradeName>
    <deviceName>Procalcitonin Control</deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105080801</emdnCode>
    <emdnDescription>BACTERIOLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CC820</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:56:24.545Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CC049QG</udiDi>
    <basicUdiDi>B-CC049QG</basicUdiDi>
    <tradeName>Anti-TP Control</tradeName>
    <deviceName>Anti-TP Control</deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105080801</emdnCode>
    <emdnDescription>BACTERIOLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CC049</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:56:04.554Z</lastUpdated>
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    <udiDi>D-8429577923012CR23</udiDi>
    <basicUdiDi>B-8429577923012CR23</basicUdiDi>
    <tradeName>CONTROL POSITIVO EN SECO CAMPYLOBACTER / CAMPYLOBACTER DRY POSITIVE CONTROL</tradeName>
    <deviceName>CONTROL POSITIVO EN SECO CAMPYLOBACTER / CAMPYLOBACTER DRY POSITIVE CONTROL</deviceName>
    <manufacturerName>OPERON, S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000004790</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105080801</emdnCode>
    <emdnDescription>BACTERIOLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9.230.XXX.12.ZZZ</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:09:14.609Z</lastUpdated>
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    <udiDi>D-8429577910837DH3R</udiDi>
    <basicUdiDi>B-8429577910837DH3R</basicUdiDi>
    <tradeName>CONTROL POSITIVO STREP PNEUMO-LEGIO / STREP PNEUMO-LEGIO POSITIVE CONTROL</tradeName>
    <deviceName>CONTROL POSITIVO STREP PNEUMO-LEGIO / STREP PNEUMO-LEGIO POSITIVE CONTROL</deviceName>
    <manufacturerName>OPERON, S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000004790</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105080801</emdnCode>
    <emdnDescription>BACTERIOLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9.108.XXX.37.ZZZ</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:09:09.799Z</lastUpdated>
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    <udiDi>00816784020758</udiDi>
    <basicUdiDi>B-00816784020758</basicUdiDi>
    <tradeName>ACCURUN 501 C. difficile Control</tradeName>
    <deviceName>ACCURUN 501 C. difficile Control</deviceName>
    <manufacturerName>LGC Clinical Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016356</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105080801</emdnCode>
    <emdnDescription>BACTERIOLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2050-0008</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:42:21.592Z</lastUpdated>
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    <udiDi>00816784020697</udiDi>
    <basicUdiDi>B-00816784020697</basicUdiDi>
    <tradeName>ACCURUN 342 CT/NG Nucleic Acid Positive Control Series 700</tradeName>
    <deviceName>ACCURUN 342 CT/NG Nucleic Acid Positive Control Series 700</deviceName>
    <manufacturerName>LGC Clinical Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016356</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105080801</emdnCode>
    <emdnDescription>BACTERIOLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2025-0068</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:42:15.193Z</lastUpdated>
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    <udiDi>00816784020680</udiDi>
    <basicUdiDi>B-00816784020680</basicUdiDi>
    <tradeName>ACCURUN 342 CT/NG Nucleic Acid Positive Control Series 100</tradeName>
    <deviceName>ACCURUN 342 CT/NG Nucleic Acid Positive Control Series 100</deviceName>
    <manufacturerName>LGC Clinical Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016356</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105080801</emdnCode>
    <emdnDescription>BACTERIOLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2025-0067</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:42:14.389Z</lastUpdated>
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    <udiDi>00816784020673</udiDi>
    <basicUdiDi>B-00816784020673</basicUdiDi>
    <tradeName>ACCURUN 841 CT/NG Negative Control</tradeName>
    <deviceName>ACCURUN 841 CT/NG Negative Control</deviceName>
    <manufacturerName>LGC Clinical Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016356</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105080801</emdnCode>
    <emdnDescription>BACTERIOLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2025-0061</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:42:10.391Z</lastUpdated>
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</eudamedExport>