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    <deviceName>careSTART™ Hb1 Analyzer</deviceName>
    <manufacturerName>WELLS BIO, INC.</manufacturerName>
    <manufacturerSrn>KR-MF-000031789</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>BHN-E00182</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:57:13.696Z</lastUpdated>
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    <manufacturerName>WELLS BIO, INC.</manufacturerName>
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    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>MULTIPLE PARAMETER - ELECTRODES/BIOSENSORS - OTHER</emdnDescription>
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    <reference>BSA-E00182</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:57:12.901Z</lastUpdated>
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    <deviceName>careSTART™ G6PD Biosensor Analyzer</deviceName>
    <manufacturerName>WELLS BIO, INC.</manufacturerName>
    <manufacturerSrn>KR-MF-000031789</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>SUBSTRATE - ELECTRODES / BIOSENSORS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BGB-E00182</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:57:12.096Z</lastUpdated>
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    <basicUdiDi>B-08809446080155</basicUdiDi>
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    <manufacturerName>WELLS BIO, INC.</manufacturerName>
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    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BSH-E02582</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T23:29:44.437Z</lastUpdated>
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    <udiDi>08809446080162</udiDi>
    <basicUdiDi>B-08809446080162</basicUdiDi>
    <tradeName>08809446080162</tradeName>
    <deviceName></deviceName>
    <manufacturerName>WELLS BIO, INC.</manufacturerName>
    <manufacturerSrn>KR-MF-000031789</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BSB-E02582</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T23:29:44.424Z</lastUpdated>
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    <udiDi>08809446080636</udiDi>
    <basicUdiDi>B-08809446080636</basicUdiDi>
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    <deviceName></deviceName>
    <manufacturerName>WELLS BIO, INC.</manufacturerName>
    <manufacturerSrn>KR-MF-000031789</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MST-N10082</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T23:29:44.410Z</lastUpdated>
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    <udiDi>08809446080698</udiDi>
    <basicUdiDi>B-08809446080698</basicUdiDi>
    <tradeName>08809446080698</tradeName>
    <deviceName></deviceName>
    <manufacturerName>WELLS BIO, INC.</manufacturerName>
    <manufacturerSrn>KR-MF-000031789</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BGO-N05082</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T23:29:44.389Z</lastUpdated>
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    <udiDi>08809446080704</udiDi>
    <basicUdiDi>B-08809446080704</basicUdiDi>
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    <deviceName></deviceName>
    <manufacturerName>WELLS BIO, INC.</manufacturerName>
    <manufacturerSrn>KR-MF-000031789</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BGT-N05082</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T23:29:44.368Z</lastUpdated>
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    <udiDi>08809446080964</udiDi>
    <basicUdiDi>B-08809446080964</basicUdiDi>
    <tradeName>08809446080964</tradeName>
    <deviceName></deviceName>
    <manufacturerName>WELLS BIO, INC.</manufacturerName>
    <manufacturerSrn>KR-MF-000031789</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HCB-N05082</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T23:29:44.346Z</lastUpdated>
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    <udiDi>08809446080971</udiDi>
    <basicUdiDi>B-08809446080971</basicUdiDi>
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    <deviceName></deviceName>
    <manufacturerName>WELLS BIO, INC.</manufacturerName>
    <manufacturerSrn>KR-MF-000031789</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BSG-E02582</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T23:29:44.318Z</lastUpdated>
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    <udiDi>08809446080988</udiDi>
    <basicUdiDi>B-08809446080988</basicUdiDi>
    <tradeName>08809446080988</tradeName>
    <deviceName></deviceName>
    <manufacturerName>WELLS BIO, INC.</manufacturerName>
    <manufacturerSrn>KR-MF-000031789</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BGS-E02582</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T23:29:44.294Z</lastUpdated>
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    <basicUdiDi>B-08809446081589</basicUdiDi>
    <tradeName>08809446081589</tradeName>
    <deviceName></deviceName>
    <manufacturerName>WELLS BIO, INC.</manufacturerName>
    <manufacturerSrn>KR-MF-000031789</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HCA-N05082</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T23:29:44.275Z</lastUpdated>
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    <udiDi>08809446081879</udiDi>
    <basicUdiDi>B-08809446081879</basicUdiDi>
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    <deviceName></deviceName>
    <manufacturerName>WELLS BIO, INC.</manufacturerName>
    <manufacturerSrn>KR-MF-000031789</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MST-N05082</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T23:29:44.257Z</lastUpdated>
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    <udiDi>08809446081992</udiDi>
    <basicUdiDi>B-08809446081992</basicUdiDi>
    <tradeName>08809446081992</tradeName>
    <deviceName></deviceName>
    <manufacturerName>WELLS BIO, INC.</manufacturerName>
    <manufacturerSrn>KR-MF-000031789</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BHP-E02582</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T23:29:44.240Z</lastUpdated>
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