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    <tradeName>FIABiomed Precisa Blood Glucose Monitoring System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HMD Biomedical Inc.</manufacturerName>
    <manufacturerSrn>TW-MF-000032809</manufacturerSrn>
    <authorisedRepresentativeName>Luana Med. B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002750</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3K-01-350031 / 3K-01-350151</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-20T10:44:49.594Z</lastUpdated>
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    <udiDi>04260236850817</udiDi>
    <basicUdiDi>B-04260236850817</basicUdiDi>
    <tradeName>FIABiomed Precisa Blood Glucose Test Strip</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HMD Biomedical Inc.</manufacturerName>
    <manufacturerSrn>TW-MF-000032809</manufacturerSrn>
    <authorisedRepresentativeName>Luana Med. B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002750</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>GLUCOSE TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
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    <udiDi>04260236850824</udiDi>
    <basicUdiDi>B-04260236850824</basicUdiDi>
    <tradeName>FIABiomed Precisa Blood Glucose Test Strip</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HMD Biomedical Inc.</manufacturerName>
    <manufacturerSrn>TW-MF-000032809</manufacturerSrn>
    <authorisedRepresentativeName>Luana Med. B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002750</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3L-10-350031</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
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    <udiDi>04260236850961</udiDi>
    <basicUdiDi>B-04260236850961</basicUdiDi>
    <tradeName>FIABiomed Precisa Blood Glucose Test Strip</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HMD Biomedical Inc.</manufacturerName>
    <manufacturerSrn>TW-MF-000032809</manufacturerSrn>
    <authorisedRepresentativeName>Luana Med. B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002750</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>GLUCOSE TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3S-01-350033</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-20T10:44:49.518Z</lastUpdated>
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    <udiDi>04260236850978</udiDi>
    <basicUdiDi>B-04260236850978</basicUdiDi>
    <tradeName>FIABiomed Precisa Blood Glucose Test Strip</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HMD Biomedical Inc.</manufacturerName>
    <manufacturerSrn>TW-MF-000032809</manufacturerSrn>
    <authorisedRepresentativeName>Luana Med. B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002750</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>GLUCOSE TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3S-01-350035</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-20T10:44:49.493Z</lastUpdated>
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    <udiDi>04260236851081</udiDi>
    <basicUdiDi>B-04260236851081</basicUdiDi>
    <tradeName>FIABiomed Precisa Blood Glucose Test Strip</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HMD Biomedical Inc.</manufacturerName>
    <manufacturerSrn>TW-MF-000032809</manufacturerSrn>
    <authorisedRepresentativeName>Luana Med. B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002750</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>GLUCOSE TEST STRIPS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>3S-01-350036</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T10:44:49.459Z</lastUpdated>
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    <udiDi>04260236851104</udiDi>
    <basicUdiDi>B-04260236851104</basicUdiDi>
    <tradeName>FIABiomed Precisa Blood Glucose Monitoring System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HMD Biomedical Inc.</manufacturerName>
    <manufacturerSrn>TW-MF-000032809</manufacturerSrn>
    <authorisedRepresentativeName>Luana Med. B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002750</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>GLUCOSE TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3K-01-350034</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-20T10:44:49.424Z</lastUpdated>
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    <udiDi>04711200724257</udiDi>
    <basicUdiDi>B-04711200724257</basicUdiDi>
    <tradeName>GlucoLeader Enhance Blood Glucose Monitoring System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HMD Biomedical Inc.</manufacturerName>
    <manufacturerSrn>TW-MF-000032809</manufacturerSrn>
    <authorisedRepresentativeName>Luana Med. B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002750</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3K-01-250063</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-18T10:09:52.929Z</lastUpdated>
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    <udiDi>04711200723946</udiDi>
    <basicUdiDi>B-04711200723946</basicUdiDi>
    <tradeName>GlucoLeader Enhance Blood Glucose Monitoring System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HMD Biomedical Inc.</manufacturerName>
    <manufacturerSrn>TW-MF-000032809</manufacturerSrn>
    <authorisedRepresentativeName>Luana Med. B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002750</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0101050205</emdnCode>
    <emdnDescription>DIABETES CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3K-01-250062</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-18T10:09:52.054Z</lastUpdated>
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    <udiDi>04711200723939</udiDi>
    <basicUdiDi>B-04711200723939</basicUdiDi>
    <tradeName>GlucoLeader Enhance Blood Glucose Test Strip</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HMD Biomedical Inc.</manufacturerName>
    <manufacturerSrn>TW-MF-000032809</manufacturerSrn>
    <authorisedRepresentativeName>Luana Med. B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002750</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0101060101</emdnCode>
    <emdnDescription>GLUCOSE TEST STRIPS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>3S-01-250061</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-18T10:09:51.122Z</lastUpdated>
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    <udiDi>04711200723601</udiDi>
    <basicUdiDi>B-04711200723601</basicUdiDi>
    <tradeName>GlucoLeader Enhance Blood Glucose Test Strip</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HMD Biomedical Inc.</manufacturerName>
    <manufacturerSrn>TW-MF-000032809</manufacturerSrn>
    <authorisedRepresentativeName>Luana Med. B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002750</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0101060101</emdnCode>
    <emdnDescription>GLUCOSE TEST STRIPS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>3L-10-250062</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-18T10:09:50.225Z</lastUpdated>
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    <udiDi>04711200723595</udiDi>
    <basicUdiDi>B-04711200723595</basicUdiDi>
    <tradeName>GlucoLeader Enhance Blood Glucose Test Strip</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HMD Biomedical Inc.</manufacturerName>
    <manufacturerSrn>TW-MF-000032809</manufacturerSrn>
    <authorisedRepresentativeName>Luana Med. B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002750</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0101060101</emdnCode>
    <emdnDescription>GLUCOSE TEST STRIPS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>3S-01-250062</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-18T10:09:49.328Z</lastUpdated>
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    <udiDi>04711200723465</udiDi>
    <basicUdiDi>B-04711200723465</basicUdiDi>
    <tradeName>FIABiomed Precisa Blood Glucose Test Strip</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HMD Biomedical Inc.</manufacturerName>
    <manufacturerSrn>TW-MF-000032809</manufacturerSrn>
    <authorisedRepresentativeName>Luana Med. B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002750</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0101060101</emdnCode>
    <emdnDescription>GLUCOSE TEST STRIPS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>3S-01-350051</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-18T10:09:48.437Z</lastUpdated>
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    <udiDi>04711200723335</udiDi>
    <basicUdiDi>B-04711200723335</basicUdiDi>
    <tradeName>GlucoLeader Enhance Glucose Control Solution</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HMD Biomedical Inc.</manufacturerName>
    <manufacturerSrn>TW-MF-000032809</manufacturerSrn>
    <authorisedRepresentativeName>Luana Med. B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002750</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0101050205</emdnCode>
    <emdnDescription>DIABETES CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3C-01-250062</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-18T10:09:47.536Z</lastUpdated>
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    <basicUdiDi>B-04711200723328</basicUdiDi>
    <tradeName>GlucoLeader Enhance Blood Glucose Test Strip</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HMD Biomedical Inc.</manufacturerName>
    <manufacturerSrn>TW-MF-000032809</manufacturerSrn>
    <authorisedRepresentativeName>Luana Med. B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002750</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0101060101</emdnCode>
    <emdnDescription>GLUCOSE TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3S-01-250037</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-18T10:09:46.631Z</lastUpdated>
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    <udiDi>04711200723137</udiDi>
    <basicUdiDi>B-04711200723137</basicUdiDi>
    <tradeName>GL GoodLife 001 Blood Glucose Test Strip</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HMD Biomedical Inc.</manufacturerName>
    <manufacturerSrn>TW-MF-000032809</manufacturerSrn>
    <authorisedRepresentativeName>Luana Med. B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002750</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>UNKNOWN</legislation>
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    <emdnDescription>GLUCOSE TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3S-01-250039</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-18T10:09:44.831Z</lastUpdated>
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    <udiDi>04711200723120</udiDi>
    <basicUdiDi>B-04711200723120</basicUdiDi>
    <tradeName>GlucoLeader Enhance Blood Glucose Monitoring System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HMD Biomedical Inc.</manufacturerName>
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    <authorisedRepresentativeName>Luana Med. B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002750</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0101060101</emdnCode>
    <emdnDescription>GLUCOSE TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3K-01-250035</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-18T10:09:43.954Z</lastUpdated>
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    <basicUdiDi>B-04711200722772</basicUdiDi>
    <tradeName>GlucoLeader Enhance Blood Glucose Test Strip</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HMD Biomedical Inc.</manufacturerName>
    <manufacturerSrn>TW-MF-000032809</manufacturerSrn>
    <authorisedRepresentativeName>Luana Med. B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002750</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0101060101</emdnCode>
    <emdnDescription>GLUCOSE TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3L-10-350034</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-18T10:09:42.125Z</lastUpdated>
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    <basicUdiDi>B-04711200722758</basicUdiDi>
    <tradeName>GL GoodLife 001 Blood Glucose Monitoring System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HMD Biomedical Inc.</manufacturerName>
    <manufacturerSrn>TW-MF-000032809</manufacturerSrn>
    <authorisedRepresentativeName>Luana Med. B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002750</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0101060101</emdnCode>
    <emdnDescription>GLUCOSE TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3K-01-250032</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
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    <tradeName>GL GoodLife 001 Blood Glucose Test Strip</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HMD Biomedical Inc.</manufacturerName>
    <manufacturerSrn>TW-MF-000032809</manufacturerSrn>
    <authorisedRepresentativeName>Luana Med. B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002750</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0101060101</emdnCode>
    <emdnDescription>GLUCOSE TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3S-01-250032</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-18T10:09:39.432Z</lastUpdated>
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