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<eudamedExport entity="devices">
  <row>
    <udiDi>08685115806956</udiDi>
    <basicUdiDi>868511580PCR140GF</basicUdiDi>
    <tradeName>LyoSens™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105040311</emdnCode>
    <emdnDescription>HSV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LYO140WS24</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-27T19:56:59.019Z</lastUpdated>
  </row>
  <row>
    <udiDi>08685115806994</udiDi>
    <basicUdiDi>868511580PCR140GF</basicUdiDi>
    <tradeName>LyoSens™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105040311</emdnCode>
    <emdnDescription>HSV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LYO140WS48</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-27T19:56:58.771Z</lastUpdated>
  </row>
  <row>
    <udiDi>08685115807038</udiDi>
    <basicUdiDi>868511580PCR140GF</basicUdiDi>
    <tradeName>LyoSens™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105040311</emdnCode>
    <emdnDescription>HSV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LYO140WS96</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-27T19:56:51.686Z</lastUpdated>
  </row>
  <row>
    <udiDi>08684595034804</udiDi>
    <basicUdiDi>868511580PCR140GF</basicUdiDi>
    <tradeName>ChainFor™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105040311</emdnCode>
    <emdnDescription>HSV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CFP140P50</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-27T19:56:51.154Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ISP-R102LV</udiDi>
    <basicUdiDi>B-ISP-R102LV</basicUdiDi>
    <tradeName>S. pneumoniae Antigen Rapid Test Cassette</tradeName>
    <deviceName>S. pneumoniae Antigen Rapid Test Cassette</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090109</emdnCode>
    <emdnDescription>STREP. PNEUMONIAE - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ISP-R102</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-27T03:37:02.311Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ISLC-R125CV</udiDi>
    <basicUdiDi>B-ISLC-R125CV</basicUdiDi>
    <tradeName>S. pneumoniae and L. pneumophila Combo Rapid Test Cassette</tradeName>
    <deviceName>S. pneumoniae and L. pneumophila Combo Rapid Test Cassette</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090199</emdnCode>
    <emdnDescription>BACTERIOLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ISLC-R125</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-27T03:37:01.493Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IMPM-402LX</udiDi>
    <basicUdiDi>B-IMPM-402LX</basicUdiDi>
    <tradeName>Mycoplasma Pneumoniae IgM Rapid Test Cassette</tradeName>
    <deviceName>Mycoplasma Pneumoniae IgM Rapid Test Cassette</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010802</emdnCode>
    <emdnDescription>MYCOPLASMA ANTIBODY ASSAYS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IMPM-402</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-27T03:37:00.695Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IMP-502UQ</udiDi>
    <basicUdiDi>B-IMP-502UQ</basicUdiDi>
    <tradeName>Mycoplasma pneumoniae Antigen Rapid Test Cassette</tradeName>
    <deviceName>Mycoplasma pneumoniae Antigen Rapid Test Cassette</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010801</emdnCode>
    <emdnDescription>MYCOPLASMA ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IMP-502</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-27T03:36:59.895Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IMP-425UX</udiDi>
    <basicUdiDi>B-IMP-425UX</basicUdiDi>
    <tradeName>Mycoplasma pneumoniae IgG/IgM Combo Rapid Test Cassette</tradeName>
    <deviceName>Mycoplasma pneumoniae IgG/IgM Combo Rapid Test Cassette</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010802</emdnCode>
    <emdnDescription>MYCOPLASMA ANTIBODY ASSAYS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IMP-425</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-27T03:36:55.107Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ILEG-R10269</udiDi>
    <basicUdiDi>B-ILEG-R10269</basicUdiDi>
    <tradeName>Legionella pneumophila Rapid Test Cassette</tradeName>
    <deviceName>Legionella pneumophila Rapid Test Cassette</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090108</emdnCode>
    <emdnDescription>LEGIONELLA - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ILEG-R102</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-27T03:36:54.290Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IECG-4029C</udiDi>
    <basicUdiDi>B-IECG-4029C</basicUdiDi>
    <tradeName>EBV VCA IgG Rapid Test Cassette</tradeName>
    <deviceName>EBV VCA IgG Rapid Test Cassette</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010504040105</emdnCode>
    <emdnDescription>EBV VCA IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IECG-402</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-27T03:36:53.503Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IECA-4027A</udiDi>
    <basicUdiDi>B-IECA-4027A</basicUdiDi>
    <tradeName>EBV VCA IgA Rapid Test Cassette</tradeName>
    <deviceName>EBV VCA IgA Rapid Test Cassette</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010504040199</emdnCode>
    <emdnDescription>EBV ANTIBODIES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IECA-402</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-27T03:36:52.703Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ICRG-402ED</udiDi>
    <basicUdiDi>B-ICRG-402ED</basicUdiDi>
    <tradeName>Cryptococcus Antigen Rapid Test Cassette</tradeName>
    <deviceName>Cryptococcus Antigen Rapid Test Cassette</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105060303</emdnCode>
    <emdnDescription>CRYPTOCOCCUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ICRG-402</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-27T03:36:47.886Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FI-LEG-102NV</udiDi>
    <basicUdiDi>B-FI-LEG-102NV</basicUdiDi>
    <tradeName>Legionella pneumophila Test Cassette</tradeName>
    <deviceName>Legionella pneumophila Test Cassette</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010501</emdnCode>
    <emdnDescription>LEGIONELLA ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FI-LEG-102</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-27T03:36:45.505Z</lastUpdated>
  </row>
  <row>
    <udiDi>08435440228974</udiDi>
    <basicUdiDi>84354402_MDXIMMUN_HHZ7D</basicUdiDi>
    <tradeName>VIASURE Herpes virus 1, Herpes virus 2 &amp; Varicella Zoster Virus Real Time PCR Detection Kit</tradeName>
    <deviceName>VIASURE Herpes virus 1, Herpes virus 2 &amp; Varicella Zoster Virus Real Time PCR Detection Kit</deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105070302</emdnCode>
    <emdnDescription>OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS-HHZ196TE</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-27T02:08:43.172Z</lastUpdated>
  </row>
  <row>
    <udiDi>06955931302263</udiDi>
    <basicUdiDi>695593130020010603GM</basicUdiDi>
    <tradeName>Nucleic Acid Extraction Reagent</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Yaneng BIOscience (Shenzhen) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013666</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>2001FC</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-26T09:18:22.422Z</lastUpdated>
  </row>
  <row>
    <udiDi>06955931302270</udiDi>
    <basicUdiDi>695593130020010603GM</basicUdiDi>
    <tradeName>Nucleic Acid Extraction Reagent</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Yaneng BIOscience (Shenzhen) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013666</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>2001FC</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-26T09:18:22.390Z</lastUpdated>
  </row>
  <row>
    <udiDi>06955931302294</udiDi>
    <basicUdiDi>695593130020080001HY</basicUdiDi>
    <tradeName>Nucleic Acid Extraction Reagent</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Yaneng BIOscience (Shenzhen) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013666</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105900103</emdnCode>
    <emdnDescription>SUPPLEMENTAL NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>200801</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-26T09:18:22.337Z</lastUpdated>
  </row>
  <row>
    <udiDi>06955931302300</udiDi>
    <basicUdiDi>695593130020080001HY</basicUdiDi>
    <tradeName>Nucleic Acid Extraction Reagent</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Yaneng BIOscience (Shenzhen) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013666</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105900103</emdnCode>
    <emdnDescription>SUPPLEMENTAL NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>200801</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-26T09:18:22.312Z</lastUpdated>
  </row>
  <row>
    <udiDi>06955931302324</udiDi>
    <basicUdiDi>695593130020090001JB</basicUdiDi>
    <tradeName>Nucleic Acid Extraction Reagent</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Yaneng BIOscience (Shenzhen) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013666</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>200901</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-26T09:18:22.252Z</lastUpdated>
  </row>
</eudamedExport>