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    <udiDi>08885019710971</udiDi>
    <basicUdiDi>888501971800815X9</basicUdiDi>
    <tradeName>08885019710971</tradeName>
    <deviceName>abGenix™ Whole Blood Genomic DNA Extraction Kit (Plate)</deviceName>
    <manufacturerName>AITbiotech Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000003510</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105900103</emdnCode>
    <emdnDescription>SUPPLEMENTAL NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>800815</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-31T21:09:34.259Z</lastUpdated>
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    <udiDi>08885019710964</udiDi>
    <basicUdiDi>888501971800814X7</basicUdiDi>
    <tradeName>08885019710964</tradeName>
    <deviceName>abGenix™ Bacteria Genomic DNA Extraction Kit (Strip)</deviceName>
    <manufacturerName>AITbiotech Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000003510</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105900101</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>800814</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-31T21:09:33.466Z</lastUpdated>
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    <udiDi>08885019710957</udiDi>
    <basicUdiDi>888501971800813X5</basicUdiDi>
    <tradeName>08885019710957</tradeName>
    <deviceName>abGenix™ Bacteria Genomic DNA Extraction Kit (Plate)</deviceName>
    <manufacturerName>AITbiotech Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000003510</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105900101</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>800813</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-31T21:09:31.962Z</lastUpdated>
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    <udiDi>08885019710056</udiDi>
    <basicUdiDi>888501971800827XG</basicUdiDi>
    <tradeName>08885019710056</tradeName>
    <deviceName>abGenix™ Tissue Genomic DNA Extraction Kit (Plate)</deviceName>
    <manufacturerName>AITbiotech Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000003510</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105900101</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>800827</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-31T21:09:28.872Z</lastUpdated>
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    <udiDi>08885013958232</udiDi>
    <basicUdiDi>888501395SSXLPWR</basicUdiDi>
    <tradeName>Sentosa SX Lysis Plate (96)</tradeName>
    <deviceName>Sentosa SX Lysis Plate</deviceName>
    <manufacturerName>Vela Operations Singapore Pte. Ltd.</manufacturerName>
    <manufacturerSrn>SG-MF-000025684</manufacturerSrn>
    <authorisedRepresentativeName>Vela Diagnostics Germany GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000016088</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105900101</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>300649</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T21:09:02.199Z</lastUpdated>
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    <udiDi>08885013958201</udiDi>
    <basicUdiDi>888501395VKVTNA2S</basicUdiDi>
    <tradeName>ViroKey HT Virus Total Nucleic Acid Kit (4x96)</tradeName>
    <deviceName>ViroKey Virus Total Nucleic Acid Kit</deviceName>
    <manufacturerName>Vela Operations Singapore Pte. Ltd.</manufacturerName>
    <manufacturerSrn>SG-MF-000025684</manufacturerSrn>
    <authorisedRepresentativeName>Vela Diagnostics Germany GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000016088</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105900101</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>301089</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T21:09:01.422Z</lastUpdated>
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    <udiDi>08885013958126</udiDi>
    <basicUdiDi>888501395SSXVTNAPlusII9L</basicUdiDi>
    <tradeName>Sentosa SX Virus Total Nucleic Acid Plus II Kit (4x16)</tradeName>
    <deviceName>Sentosa SX Virus Total Nucleic Acid Plus II Kit (4x16)</deviceName>
    <manufacturerName>Vela Operations Singapore Pte. Ltd.</manufacturerName>
    <manufacturerSrn>SG-MF-000025684</manufacturerSrn>
    <authorisedRepresentativeName>Vela Diagnostics Germany GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000016088</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105900101</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>300351</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T21:08:59.810Z</lastUpdated>
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    <udiDi>08885013958102</udiDi>
    <basicUdiDi>888501395SSXLBVV</basicUdiDi>
    <tradeName>Sentosa SX Lysis Beads</tradeName>
    <deviceName>Sentosa SX Lysis Beads</deviceName>
    <manufacturerName>Vela Operations Singapore Pte. Ltd.</manufacturerName>
    <manufacturerSrn>SG-MF-000025684</manufacturerSrn>
    <authorisedRepresentativeName>Vela Diagnostics Germany GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000016088</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105900101</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>300291</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T21:08:57.518Z</lastUpdated>
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  <row>
    <udiDi>08885013958096</udiDi>
    <basicUdiDi>888501395SSXWBWW</basicUdiDi>
    <tradeName>Sentosa SX Whole Blood Kit (4x24)</tradeName>
    <deviceName>Sentosa SX Whole Blood Kit (4x24)</deviceName>
    <manufacturerName>Vela Operations Singapore Pte. Ltd.</manufacturerName>
    <manufacturerSrn>SG-MF-000025684</manufacturerSrn>
    <authorisedRepresentativeName>Vela Diagnostics Germany GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000016088</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105900101</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>300252</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T21:08:55.001Z</lastUpdated>
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  <row>
    <udiDi>08885013958072</udiDi>
    <basicUdiDi>888501395SSXVTNAPlus7G</basicUdiDi>
    <tradeName>Sentosa SX Virus Total Nucleic Acid Plus Kit (4x24)</tradeName>
    <deviceName>Sentosa SX Virus Total Nucleic Acid Plus Kit (4x24)</deviceName>
    <manufacturerName>Vela Operations Singapore Pte. Ltd.</manufacturerName>
    <manufacturerSrn>SG-MF-000025684</manufacturerSrn>
    <authorisedRepresentativeName>Vela Diagnostics Germany GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000016088</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105900101</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>300154</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T21:08:54.204Z</lastUpdated>
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  <row>
    <udiDi>08885013958034</udiDi>
    <basicUdiDi>888501395SSXVTNAv2WK</basicUdiDi>
    <tradeName>Sentosa SX Virus Total Nucleic Acid Kit v2.0 (4x24)</tradeName>
    <deviceName>Sentosa SX Virus Total Nucleic Acid Kit v2.0 (4x24)</deviceName>
    <manufacturerName>Vela Operations Singapore Pte. Ltd.</manufacturerName>
    <manufacturerSrn>SG-MF-000025684</manufacturerSrn>
    <authorisedRepresentativeName>Vela Diagnostics Germany GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000016088</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105900101</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>300042</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T21:08:52.595Z</lastUpdated>
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    <udiDi>08806133042212</udiDi>
    <basicUdiDi>880613300028BR</basicUdiDi>
    <tradeName>ichroma™ Dengue NS1 Ag</tradeName>
    <deviceName>ichroma™ Dengue NS1 Ag</deviceName>
    <manufacturerName>Boditech Med Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000011028</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105040611</emdnCode>
    <emdnDescription>DENGUE VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CFPC-62</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-31T21:00:49.345Z</lastUpdated>
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  <row>
    <udiDi>08806133042137</udiDi>
    <basicUdiDi>880613300027BP</basicUdiDi>
    <tradeName>ichroma™ Dengue IgG/IgM</tradeName>
    <deviceName>ichroma™ Dengue IgG/IgM</deviceName>
    <manufacturerName>Boditech Med Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000011028</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105040611</emdnCode>
    <emdnDescription>DENGUE VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CFPC-60</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-31T21:00:49.153Z</lastUpdated>
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    <udiDi>08806133042090</udiDi>
    <basicUdiDi>880613300548CQ</basicUdiDi>
    <tradeName>AFIAS Dengue IgG/IgM</tradeName>
    <deviceName>AFIAS Dengue IgG/IgM</deviceName>
    <manufacturerName>Boditech Med Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000011028</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105040611</emdnCode>
    <emdnDescription>DENGUE VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SMFP-41</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T21:00:42.565Z</lastUpdated>
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    <udiDi>08806133041796</udiDi>
    <basicUdiDi>880613300530C5</basicUdiDi>
    <tradeName>AFIAS NORO</tradeName>
    <deviceName>AFIAS NORO</deviceName>
    <manufacturerName>Boditech Med Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000011028</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105040616</emdnCode>
    <emdnDescription>NOROVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SMFP-26</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-31T21:00:41.811Z</lastUpdated>
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    <udiDi>08699195610433</udiDi>
    <basicUdiDi>86991956100LHAB.01WV</basicUdiDi>
    <tradeName>Laboquick</tradeName>
    <deviceName>Laboquick Helicobacter Pylori Ab Test</deviceName>
    <manufacturerName>Koroglu Medikal Tibbi Malzemeleri Kozmetik Ithalat Ihracat Sanayi Ve Ticaret Ltd. Sti.</manufacturerName>
    <manufacturerSrn>TR-MF-000032257</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105010402</emdnCode>
    <emdnDescription>H. PYLORI ANTIBODY ASSAYS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LHAB.01</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-31T20:41:43.494Z</lastUpdated>
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    <udiDi>08685214524232</udiDi>
    <basicUdiDi>868521452PCR157GH</basicUdiDi>
    <tradeName>LyoSens™</tradeName>
    <deviceName>Sepsis v1.0 Genotyping qPCR Kit</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105070202</emdnCode>
    <emdnDescription>BLOOD STREAM INFECTION/SEPSIS (BACTERIA &amp; FUNGI) - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LYO157WS24</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-31T20:29:36.849Z</lastUpdated>
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    <udiDi>08685115806796</udiDi>
    <basicUdiDi>868511580PCR138GU</basicUdiDi>
    <tradeName>LyoSens™</tradeName>
    <deviceName>VZV qPCR Kit</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105040399</emdnCode>
    <emdnDescription>HSV REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LYO138WS96</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-31T20:29:35.243Z</lastUpdated>
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    <udiDi>08685214523983</udiDi>
    <basicUdiDi>868521452PCR155GD</basicUdiDi>
    <tradeName>LyoSens™</tradeName>
    <deviceName>Gastroenteritis v1.0 Genotyping qPCR Kit</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105070504</emdnCode>
    <emdnDescription>GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LYO155WS24</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-31T20:29:34.449Z</lastUpdated>
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    <udiDi>08685115804563</udiDi>
    <basicUdiDi>868511580PCR127GP</basicUdiDi>
    <tradeName>LyoSens™</tradeName>
    <deviceName>NiPV qPCR Kit</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105040599</emdnCode>
    <emdnDescription>VIROLOGY - NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LYO127WS24</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-31T20:29:19.175Z</lastUpdated>
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