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    <deviceName>TRUPCR® BCR-ABL1 Quantitative  Kit – Major (WHO IS), Minor &amp; Micro</deviceName>
    <manufacturerName>3B BlackBio Dx Limited</manufacturerName>
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    <legislation>IVDR 2017/746</legislation>
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    <lastUpdated>2026-07-03T19:06:26.142Z</lastUpdated>
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    <tradeName>TRUPCR® IDH1/2 Detection &amp; Differentiation Kit</tradeName>
    <deviceName>TRUPCR® IDH1/2 Detection &amp; Differentiation Kit</deviceName>
    <manufacturerName>3B BlackBio Dx Limited</manufacturerName>
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    <tradeName>TRUPCR® BCR-ABL1 Minor Quantitative Kit</tradeName>
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    <manufacturerName>3B BlackBio Dx Limited</manufacturerName>
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    <tradeName>Eonis SCID-SMA kit</tradeName>
    <deviceName>Eonis SCID-SMA kit</deviceName>
    <manufacturerName>Wallac Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000022620</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>POLYGENETIC DISORDERS TESTS - OTHER</emdnDescription>
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    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:04:17.489Z</lastUpdated>
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    <udiDi>08595223921925</udiDi>
    <basicUdiDi>85952239000007X8</basicUdiDi>
    <tradeName>gb GENETIC LACTO</tradeName>
    <deviceName>gb GENETIC LACTO</deviceName>
    <manufacturerName>GENERI BIOTECH s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000018857</manufacturerSrn>
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    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010299</emdnCode>
    <emdnDescription>POLYGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3219-050</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-30T13:57:05.244Z</lastUpdated>
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    <basicUdiDi>89080153043B1338LE</basicUdiDi>
    <tradeName>TRUPCR® IDH1/2 Detection &amp; Differentiation Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>3B BlackBio Dx Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000023698</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
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    <emdnDescription>POLYGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T08:20:08.001Z</lastUpdated>
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    <tradeName>TRUPCR® BCR-ABL Kit – Quantitative Major (WHO IS) Minor &amp; Micro</tradeName>
    <deviceName></deviceName>
    <manufacturerName>3B BlackBio Dx Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000023698</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
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    <emdnDescription>POLYGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-06-29T08:20:07.683Z</lastUpdated>
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    <tradeName>TRUPCR® BCR-ABL Kit – Quantitative Major (WHO IS) Minor &amp; Micro</tradeName>
    <deviceName></deviceName>
    <manufacturerName>3B BlackBio Dx Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000023698</manufacturerSrn>
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    <emdnDescription>POLYGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3B1267/C</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T08:20:07.591Z</lastUpdated>
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    <basicUdiDi>89080153043B1291LD</basicUdiDi>
    <tradeName>TRUPCR® BCR-ABL Kit - Minor Quantitative</tradeName>
    <deviceName></deviceName>
    <manufacturerName>3B BlackBio Dx Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000023698</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010299</emdnCode>
    <emdnDescription>POLYGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3B1292</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T08:20:07.564Z</lastUpdated>
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    <udiDi>08908015304705</udiDi>
    <basicUdiDi>89080153043B1339LG</basicUdiDi>
    <tradeName>TRUPCR® MGMT Methylation Detection Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>3B BlackBio Dx Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000023698</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010299</emdnCode>
    <emdnDescription>POLYGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3B1340</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T08:20:07.098Z</lastUpdated>
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    <tradeName>NeoNat SCID-SMA Real-Time PCR Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Labsystems Diagnostics Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000018281</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0106010299</emdnCode>
    <emdnDescription>POLYGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8100483</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:40:44.915Z</lastUpdated>
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    <tradeName>NeoNat SCID-SMA Real-Time PCR Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Labsystems Diagnostics Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000018281</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
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    <emdnCode>W0106010299</emdnCode>
    <emdnDescription>POLYGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:40:43.791Z</lastUpdated>
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    <tradeName>NeoNat SCID-SMA Real-Time PCR Kit</tradeName>
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    <manufacturerName>Labsystems Diagnostics Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000018281</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0106010299</emdnCode>
    <emdnDescription>POLYGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8100481</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:40:42.573Z</lastUpdated>
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    <tradeName>NeoNat SMA Real-Time PCR Kit</tradeName>
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    <manufacturerName>Labsystems Diagnostics Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000018281</manufacturerSrn>
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    <emdnDescription>POLYGENETIC DISORDERS TESTS - OTHER</emdnDescription>
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    <lastUpdated>2026-06-23T08:40:40.111Z</lastUpdated>
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    <tradeName>NeoNat SMA Real-Time PCR Kit</tradeName>
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    <manufacturerName>Labsystems Diagnostics Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000018281</manufacturerSrn>
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    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <lastUpdated>2026-06-23T08:40:38.915Z</lastUpdated>
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    <tradeName>NeoNat SMA Real-Time PCR Kit</tradeName>
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    <manufacturerName>Labsystems Diagnostics Oy</manufacturerName>
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    <tradeName>NeoNat SCID Real-Time PCR Kit</tradeName>
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    <manufacturerName>Labsystems Diagnostics Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000018281</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnDescription>POLYGENETIC DISORDERS TESTS - OTHER</emdnDescription>
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    <emdnDescription>POLYGENETIC DISORDERS TESTS - OTHER</emdnDescription>
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    <tradeName>NeoNat SCID Real-Time PCR Kit</tradeName>
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    <manufacturerName>Labsystems Diagnostics Oy</manufacturerName>
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    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>UNKNOWN</legislation>
    <emdnCode>W0106010299</emdnCode>
    <emdnDescription>POLYGENETIC DISORDERS TESTS - OTHER</emdnDescription>
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    <tradeName>NeoNat SCID-SMA Multiplex Real-Time PCR Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Labsystems Diagnostics Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000018281</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0106010299</emdnCode>
    <emdnDescription>POLYGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8100413</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:40:31.709Z</lastUpdated>
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