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<eudamedExport entity="devices">
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    <udiDi>08684387214506</udiDi>
    <basicUdiDi>B-08684387214506</basicUdiDi>
    <tradeName>RevoDx DNA Purification Kit from Respiratory Samples</tradeName>
    <deviceName>RevoDx DNA Purification Kit from Respiratory Samples</deviceName>
    <manufacturerName>İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.</manufacturerName>
    <manufacturerSrn>TR-MF-000047330</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105900101</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IP201907-25</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T23:01:52.562Z</lastUpdated>
  </row>
  <row>
    <udiDi>08684387214490</udiDi>
    <basicUdiDi>B-08684387214490</basicUdiDi>
    <tradeName>RevoDx Viral Nucleic Acid Purification Kit</tradeName>
    <deviceName>RevoDx Viral Nucleic Acid Purification Kit</deviceName>
    <manufacturerName>İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.</manufacturerName>
    <manufacturerSrn>TR-MF-000047330</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105900101</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IP201906-100</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T23:01:51.758Z</lastUpdated>
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  <row>
    <udiDi>08684387214483</udiDi>
    <basicUdiDi>B-08684387214483</basicUdiDi>
    <tradeName>RevoDx Viral Nucleic Acid Purification Kit</tradeName>
    <deviceName>RevoDx Viral Nucleic Acid Purification Kit</deviceName>
    <manufacturerName>İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.</manufacturerName>
    <manufacturerSrn>TR-MF-000047330</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105900101</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8684387214483</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T23:01:50.961Z</lastUpdated>
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  <row>
    <udiDi>08684387214476</udiDi>
    <basicUdiDi>B-08684387214476</basicUdiDi>
    <tradeName>RevoDx Viral Nucleic Acid Purification Kit</tradeName>
    <deviceName>RevoDx Viral Nucleic Acid Purification Kit</deviceName>
    <manufacturerName>İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.</manufacturerName>
    <manufacturerSrn>TR-MF-000047330</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105900101</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IP201906-25</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T23:01:50.160Z</lastUpdated>
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  <row>
    <udiDi>08684387214322</udiDi>
    <basicUdiDi>B-08684387214322</basicUdiDi>
    <tradeName>RevoDx Atypical pneumonia Pathogen Detection Kit</tradeName>
    <deviceName>RevoDx Atypical pneumonia Pathogen Detection Kit</deviceName>
    <manufacturerName>İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.</manufacturerName>
    <manufacturerSrn>TR-MF-000047330</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105900101</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IP202605-50</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T23:01:26.964Z</lastUpdated>
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  <row>
    <udiDi>08684387214339</udiDi>
    <basicUdiDi>B-08684387214339</basicUdiDi>
    <tradeName>RevoDx Atypical pneumonia Pathogen Detection Kit</tradeName>
    <deviceName>RevoDx Atypical pneumonia Pathogen Detection Kit</deviceName>
    <manufacturerName>İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.</manufacturerName>
    <manufacturerSrn>TR-MF-000047330</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105900101</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IP202605-100</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T23:01:24.593Z</lastUpdated>
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  <row>
    <udiDi>08684387210720</udiDi>
    <basicUdiDi>B-08684387210720</basicUdiDi>
    <tradeName>DirEXT OneStep HPV DNA Extraction Reagent</tradeName>
    <deviceName>DirEXT OneStep HPV DNA Extraction Reagent</deviceName>
    <manufacturerName>İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.</manufacturerName>
    <manufacturerSrn>TR-MF-000047330</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105900101</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IP202304-50</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T22:47:47.914Z</lastUpdated>
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  <row>
    <udiDi>08684387210713</udiDi>
    <basicUdiDi>B-08684387210713</basicUdiDi>
    <tradeName>DirEXT OneStep Pathogen DNA/RNA Extraction Reagent</tradeName>
    <deviceName>DirEXT OneStep Pathogen DNA/RNA Extraction Reagent</deviceName>
    <manufacturerName>İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.</manufacturerName>
    <manufacturerSrn>TR-MF-000047330</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105900101</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IP202319-50</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T22:47:44.585Z</lastUpdated>
  </row>
  <row>
    <udiDi>08885013958218</udiDi>
    <basicUdiDi>888501395VKVTNA2S</basicUdiDi>
    <tradeName>ViroKey SX Virus Total Nucleic Acid (4x48)</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>W0105900101</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>300678</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T07:19:18.238Z</lastUpdated>
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  <row>
    <udiDi>08885013958249</udiDi>
    <basicUdiDi>888501395SSXLPWR</basicUdiDi>
    <tradeName>Sentosa SX Lysis Plate (10x96)</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>W0105900101</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>300704</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T07:19:18.174Z</lastUpdated>
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  <row>
    <udiDi>08885019711053</udiDi>
    <basicUdiDi>888501971302011U6</basicUdiDi>
    <tradeName>08885019711053</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>W0105900103</emdnCode>
    <emdnDescription>SUPPLEMENTAL NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>302011</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T07:18:54.452Z</lastUpdated>
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  <row>
    <udiDi>08885019711077</udiDi>
    <basicUdiDi>888501971302014UC</basicUdiDi>
    <tradeName>08885019711077</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>W0105900103</emdnCode>
    <emdnDescription>SUPPLEMENTAL NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>302014</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T07:18:54.402Z</lastUpdated>
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  <row>
    <udiDi>08905459001337</udiDi>
    <basicUdiDi>8905459RNAEXTAU</basicUdiDi>
    <tradeName>08905459001337</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Meril Diagnostics Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000028158</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105900101</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MBTREK-07 MBTREK-08 MBTREK-09</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:46:32.376Z</lastUpdated>
  </row>
  <row>
    <udiDi>08905459001368</udiDi>
    <basicUdiDi>8905459RNAEXTAU</basicUdiDi>
    <tradeName>08905459001368</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Meril Diagnostics Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000028158</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105900101</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MBRIKG-01 MBRIKG-02</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:46:32.356Z</lastUpdated>
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  <row>
    <udiDi>08057723370592</udiDi>
    <basicUdiDi>B-08057723370592</basicUdiDi>
    <tradeName>08057723370592</tradeName>
    <deviceName>SMART SNP Sample Diluent</deviceName>
    <manufacturerName>BIOCLARMA S.R.L.</manufacturerName>
    <manufacturerSrn>IT-MF-000030384</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105900201</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SNPD-SD</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T18:37:27.035Z</lastUpdated>
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    <udiDi>08057723370561</udiDi>
    <basicUdiDi>B-08057723370561</basicUdiDi>
    <tradeName>08057723370561</tradeName>
    <deviceName>SensiQuant Direct CELL Buffer</deviceName>
    <manufacturerName>BIOCLARMA S.R.L.</manufacturerName>
    <manufacturerSrn>IT-MF-000030384</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105900201</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SQTd-CB</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T18:37:24.626Z</lastUpdated>
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  <row>
    <udiDi>06975166200233</udiDi>
    <basicUdiDi>B-06975166200233</basicUdiDi>
    <tradeName>06975166200233</tradeName>
    <deviceName>Monkeypox Virus DNA Detection Kit (Real-Time PCR)</deviceName>
    <manufacturerName>Avioq Bio-tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000048146</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105900102</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>96 Tests/Kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:01:57.988Z</lastUpdated>
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  <row>
    <udiDi>06975166200226</udiDi>
    <basicUdiDi>B-06975166200226</basicUdiDi>
    <tradeName>06975166200226</tradeName>
    <deviceName>Monkeypox Virus DNA Detection Kit (Real-Time PCR)</deviceName>
    <manufacturerName>Avioq Bio-tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000048146</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105900102</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>48 Tests/Kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:01:53.976Z</lastUpdated>
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    <udiDi>06975166200219</udiDi>
    <basicUdiDi>B-06975166200219</basicUdiDi>
    <tradeName>06975166200219</tradeName>
    <deviceName>Monkeypox Virus DNA Detection Kit (Real-Time PCR)</deviceName>
    <manufacturerName>Avioq Bio-tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000048146</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105900102</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>24 Tests/Kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:01:53.191Z</lastUpdated>
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    <udiDi>06975146603665</udiDi>
    <basicUdiDi>B-06975146603665</basicUdiDi>
    <tradeName>06975146603665</tradeName>
    <deviceName>Monkeypox Virus Molecular Diagnostic Kit (Fluorescent PCR Test) (Lyophilized)</deviceName>
    <manufacturerName>BioDetect（Xiamen）Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001098</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105900101</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100 tests/kit</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:01:16.304Z</lastUpdated>
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