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    <deviceName></deviceName>
    <manufacturerName>Innovate Orthopaedics</manufacturerName>
    <manufacturerSrn>GB-MF-000012886</manufacturerSrn>
    <authorisedRepresentativeName>Acorn Regulatory Consultancy Services Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000592</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
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    <emdnDescription>INTERFERENCE SCREWS</emdnDescription>
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    <lastUpdated>2026-06-19T20:15:29.751Z</lastUpdated>
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    <basicUdiDi>B-05060464140129</basicUdiDi>
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    <deviceName></deviceName>
    <manufacturerName>Innovate Orthopaedics</manufacturerName>
    <manufacturerSrn>GB-MF-000012886</manufacturerSrn>
    <authorisedRepresentativeName>Acorn Regulatory Consultancy Services Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000592</authorisedRepresentativeSrn>
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    <legislation>UNKNOWN</legislation>
    <emdnCode>P09120605</emdnCode>
    <emdnDescription>INTERFERENCE SCREWS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-19T20:15:28.871Z</lastUpdated>
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    <udiDi>05060464140112</udiDi>
    <basicUdiDi>B-05060464140112</basicUdiDi>
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    <deviceName></deviceName>
    <manufacturerName>Innovate Orthopaedics</manufacturerName>
    <manufacturerSrn>GB-MF-000012886</manufacturerSrn>
    <authorisedRepresentativeName>Acorn Regulatory Consultancy Services Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000592</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>P09120605</emdnCode>
    <emdnDescription>INTERFERENCE SCREWS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-19T20:15:28.089Z</lastUpdated>
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    <udiDi>05060464140105</udiDi>
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    <deviceName></deviceName>
    <manufacturerName>Innovate Orthopaedics</manufacturerName>
    <manufacturerSrn>GB-MF-000012886</manufacturerSrn>
    <authorisedRepresentativeName>Acorn Regulatory Consultancy Services Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000592</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>P09120605</emdnCode>
    <emdnDescription>INTERFERENCE SCREWS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10010</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-19T20:15:27.169Z</lastUpdated>
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    <udiDi>05060464140099</udiDi>
    <basicUdiDi>B-05060464140099</basicUdiDi>
    <tradeName>Quick-Start</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Innovate Orthopaedics</manufacturerName>
    <manufacturerSrn>GB-MF-000012886</manufacturerSrn>
    <authorisedRepresentativeName>Acorn Regulatory Consultancy Services Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000592</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>P09120605</emdnCode>
    <emdnDescription>INTERFERENCE SCREWS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10009</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-19T20:15:26.292Z</lastUpdated>
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    <udiDi>05060464140082</udiDi>
    <basicUdiDi>B-05060464140082</basicUdiDi>
    <tradeName>05060464140082</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Innovate Orthopaedics</manufacturerName>
    <manufacturerSrn>GB-MF-000012886</manufacturerSrn>
    <authorisedRepresentativeName>Acorn Regulatory Consultancy Services Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000592</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>P09120605</emdnCode>
    <emdnDescription>INTERFERENCE SCREWS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10008</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-19T20:15:25.258Z</lastUpdated>
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    <udiDi>05060464140075</udiDi>
    <basicUdiDi>B-05060464140075</basicUdiDi>
    <tradeName>05060464140075</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Innovate Orthopaedics</manufacturerName>
    <manufacturerSrn>GB-MF-000012886</manufacturerSrn>
    <authorisedRepresentativeName>Acorn Regulatory Consultancy Services Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000592</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>P09120605</emdnCode>
    <emdnDescription>INTERFERENCE SCREWS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10007</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-19T20:15:24.958Z</lastUpdated>
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    <udiDi>05060464140068</udiDi>
    <basicUdiDi>B-05060464140068</basicUdiDi>
    <tradeName>05060464140068</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Innovate Orthopaedics</manufacturerName>
    <manufacturerSrn>GB-MF-000012886</manufacturerSrn>
    <authorisedRepresentativeName>Acorn Regulatory Consultancy Services Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000592</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>P09120605</emdnCode>
    <emdnDescription>INTERFERENCE SCREWS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10006</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-19T20:15:23.455Z</lastUpdated>
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    <udiDi>05060464140051</udiDi>
    <basicUdiDi>B-05060464140051</basicUdiDi>
    <tradeName>05060464140051</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Innovate Orthopaedics</manufacturerName>
    <manufacturerSrn>GB-MF-000012886</manufacturerSrn>
    <authorisedRepresentativeName>Acorn Regulatory Consultancy Services Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000592</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>P09120605</emdnCode>
    <emdnDescription>INTERFERENCE SCREWS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10005</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-19T20:15:22.566Z</lastUpdated>
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    <udiDi>05060464140044</udiDi>
    <basicUdiDi>B-05060464140044</basicUdiDi>
    <tradeName>05060464140044</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Innovate Orthopaedics</manufacturerName>
    <manufacturerSrn>GB-MF-000012886</manufacturerSrn>
    <authorisedRepresentativeName>Acorn Regulatory Consultancy Services Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000592</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>P09120605</emdnCode>
    <emdnDescription>INTERFERENCE SCREWS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10004</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-19T20:15:21.667Z</lastUpdated>
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    <udiDi>05060464140037</udiDi>
    <basicUdiDi>B-05060464140037</basicUdiDi>
    <tradeName>05060464140037</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Innovate Orthopaedics</manufacturerName>
    <manufacturerSrn>GB-MF-000012886</manufacturerSrn>
    <authorisedRepresentativeName>Acorn Regulatory Consultancy Services Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000592</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>P09120605</emdnCode>
    <emdnDescription>INTERFERENCE SCREWS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10003</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-19T20:15:20.756Z</lastUpdated>
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    <udiDi>05060464140020</udiDi>
    <basicUdiDi>B-05060464140020</basicUdiDi>
    <tradeName>05060464140020</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Innovate Orthopaedics</manufacturerName>
    <manufacturerSrn>GB-MF-000012886</manufacturerSrn>
    <authorisedRepresentativeName>Acorn Regulatory Consultancy Services Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000592</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>P09120605</emdnCode>
    <emdnDescription>INTERFERENCE SCREWS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10002</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-19T20:15:19.923Z</lastUpdated>
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    <udiDi>05060464140013</udiDi>
    <basicUdiDi>B-05060464140013</basicUdiDi>
    <tradeName>05060464140013</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Innovate Orthopaedics</manufacturerName>
    <manufacturerSrn>GB-MF-000012886</manufacturerSrn>
    <authorisedRepresentativeName>Acorn Regulatory Consultancy Services Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000592</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>P09120605</emdnCode>
    <emdnDescription>INTERFERENCE SCREWS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10001</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-19T20:15:19.024Z</lastUpdated>
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    <udiDi>05060456182434</udiDi>
    <basicUdiDi>506045618AGILITYBB</basicUdiDi>
    <tradeName>AGILITY AI</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Dynex Technologies Inc</manufacturerName>
    <manufacturerSrn>US-MF-000014753</manufacturerSrn>
    <authorisedRepresentativeName>Acorn Regulatory Consultancy Services Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000592</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0201020101</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>67000AI</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-19T20:13:58.363Z</lastUpdated>
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    <udiDi>05060456180690</udiDi>
    <basicUdiDi>506045618DS2DE</basicUdiDi>
    <tradeName>DS Matrix Software</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Dynex Technologies Inc</manufacturerName>
    <manufacturerSrn>US-MF-000014753</manufacturerSrn>
    <authorisedRepresentativeName>Acorn Regulatory Consultancy Services Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000592</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0201020101</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>62800</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-19T20:13:57.436Z</lastUpdated>
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    <udiDi>05060456180614</udiDi>
    <basicUdiDi>506045618DS2DE</basicUdiDi>
    <tradeName>DEEP WELL STRIPS</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Dynex Technologies Inc</manufacturerName>
    <manufacturerSrn>US-MF-000014753</manufacturerSrn>
    <authorisedRepresentativeName>Acorn Regulatory Consultancy Services Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000592</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0201020101</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>62910</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-19T20:13:56.533Z</lastUpdated>
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    <tradeName>Revelation DSX Software</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Dynex Technologies Inc</manufacturerName>
    <manufacturerSrn>US-MF-000014753</manufacturerSrn>
    <authorisedRepresentativeName>Acorn Regulatory Consultancy Services Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000592</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0201020101</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>65078</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-19T20:13:55.712Z</lastUpdated>
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    <deviceName></deviceName>
    <manufacturerName>Dynex Technologies Inc</manufacturerName>
    <manufacturerSrn>US-MF-000014753</manufacturerSrn>
    <authorisedRepresentativeName>Acorn Regulatory Consultancy Services Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000592</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0201020101</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>67800</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-19T20:13:54.738Z</lastUpdated>
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    <udiDi>05060456180317</udiDi>
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    <deviceName></deviceName>
    <manufacturerName>Dynex Technologies Inc</manufacturerName>
    <manufacturerSrn>US-MF-000014753</manufacturerSrn>
    <authorisedRepresentativeName>Acorn Regulatory Consultancy Services Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000592</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0201020101</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>62000</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-19T20:13:53.828Z</lastUpdated>
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    <tradeName>DSX Automated ELISA with 4 incubators and sample ID</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Dynex Technologies Inc</manufacturerName>
    <manufacturerSrn>US-MF-000014753</manufacturerSrn>
    <authorisedRepresentativeName>Acorn Regulatory Consultancy Services Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000592</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0201020101</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>65500</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-19T20:13:52.950Z</lastUpdated>
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