<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>04251557100903</udiDi>
    <basicUdiDi>B-04251557100903</basicUdiDi>
    <tradeName>04251557100903</tradeName>
    <deviceName>Mycoplasma genitalium / Mycoplasma hominis Multiplex PCR kit</deviceName>
    <manufacturerName>Astra Biotech GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000026439</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010501080302</emdnCode>
    <emdnDescription>UROGENITAL MYCOPLASMA DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>85-01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T04:46:34.531Z</lastUpdated>
  </row>
  <row>
    <udiDi>04251557100859</udiDi>
    <basicUdiDi>B-04251557100859</basicUdiDi>
    <tradeName>04251557100859</tradeName>
    <deviceName>Trichomonas vaginalis PCR kit (Form T)</deviceName>
    <manufacturerName>Astra Biotech GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000026439</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050310</emdnCode>
    <emdnDescription>TRICHOMONAS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>84-06</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T04:46:33.735Z</lastUpdated>
  </row>
  <row>
    <udiDi>04251557100842</udiDi>
    <basicUdiDi>B-04251557100842</basicUdiDi>
    <tradeName>04251557100842</tradeName>
    <deviceName>Trichomonas vaginalis PCR kit (Form S)</deviceName>
    <manufacturerName>Astra Biotech GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000026439</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050310</emdnCode>
    <emdnDescription>TRICHOMONAS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>84-05</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T04:46:33.423Z</lastUpdated>
  </row>
  <row>
    <udiDi>04251557100835</udiDi>
    <basicUdiDi>B-04251557100835</basicUdiDi>
    <tradeName>04251557100835</tradeName>
    <deviceName>Neisseria gonorrhoeae PCR kit (Form T)</deviceName>
    <manufacturerName>Astra Biotech GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000026439</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010203</emdnCode>
    <emdnDescription>GONOCOCCAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>84-04</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T04:46:33.390Z</lastUpdated>
  </row>
  <row>
    <udiDi>04251557100828</udiDi>
    <basicUdiDi>B-04251557100828</basicUdiDi>
    <tradeName>04251557100828</tradeName>
    <deviceName>Neisseria gonorrhoeae PCR kit (Form S)</deviceName>
    <manufacturerName>Astra Biotech GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000026439</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010203</emdnCode>
    <emdnDescription>GONOCOCCAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>84-03</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T04:46:27.337Z</lastUpdated>
  </row>
  <row>
    <udiDi>04251557100811</udiDi>
    <basicUdiDi>B-04251557100811</basicUdiDi>
    <tradeName>04251557100811</tradeName>
    <deviceName>Neisseria gonorrhoeae PCR kit (Form F)</deviceName>
    <manufacturerName>Astra Biotech GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000026439</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010203</emdnCode>
    <emdnDescription>GONOCOCCAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>84-01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T04:46:26.534Z</lastUpdated>
  </row>
  <row>
    <udiDi>04251557100606</udiDi>
    <basicUdiDi>B-04251557100606</basicUdiDi>
    <tradeName>04251557100606</tradeName>
    <deviceName>Ferritin kit</deviceName>
    <manufacturerName>Astra Biotech GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000026439</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102070102</emdnCode>
    <emdnDescription>FERRITIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>40-01 A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T04:46:25.734Z</lastUpdated>
  </row>
  <row>
    <udiDi>04251557100590</udiDi>
    <basicUdiDi>B-04251557100590</basicUdiDi>
    <tradeName>04251557100590</tradeName>
    <deviceName>Ferritin kit</deviceName>
    <manufacturerName>Astra Biotech GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000026439</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102070102</emdnCode>
    <emdnDescription>FERRITIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>40-01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T04:46:24.933Z</lastUpdated>
  </row>
  <row>
    <udiDi>04251557100484</udiDi>
    <basicUdiDi>B-04251557100484</basicUdiDi>
    <tradeName>04251557100484</tradeName>
    <deviceName>Free T3 kit</deviceName>
    <manufacturerName>Astra Biotech GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000026439</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020401</emdnCode>
    <emdnDescription>FREE TRIIODOTHYRONINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>24-09 A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T04:46:20.936Z</lastUpdated>
  </row>
  <row>
    <udiDi>04251557100477</udiDi>
    <basicUdiDi>B-04251557100477</basicUdiDi>
    <tradeName>04251557100477</tradeName>
    <deviceName>Free T3 kit</deviceName>
    <manufacturerName>Astra Biotech GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000026439</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020401</emdnCode>
    <emdnDescription>FREE TRIIODOTHYRONINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>24-09</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T04:46:20.140Z</lastUpdated>
  </row>
  <row>
    <udiDi>04251557100446</udiDi>
    <basicUdiDi>B-04251557100446</basicUdiDi>
    <tradeName>04251557100446</tradeName>
    <deviceName>Anti-TG kit</deviceName>
    <manufacturerName>Astra Biotech GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000026439</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100303</emdnCode>
    <emdnDescription>THYROGLOBULIN AUTOANTIBODY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>24-07 A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T04:46:19.335Z</lastUpdated>
  </row>
  <row>
    <udiDi>04251557100439</udiDi>
    <basicUdiDi>B-04251557100439</basicUdiDi>
    <tradeName>04251557100439</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Astra Biotech GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000026439</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102100303</emdnCode>
    <emdnDescription>THYROGLOBULIN AUTOANTIBODY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>24-07</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T04:46:18.525Z</lastUpdated>
  </row>
  <row>
    <udiDi>04251557100422</udiDi>
    <basicUdiDi>B-04251557100422</basicUdiDi>
    <tradeName>04251557100422</tradeName>
    <deviceName>Anti-TPO kit</deviceName>
    <manufacturerName>Astra Biotech GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000026439</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100301</emdnCode>
    <emdnDescription>THYROID PEROXIDASE (INCL. MICROSOMAL) ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>24-06 A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T04:46:14.542Z</lastUpdated>
  </row>
  <row>
    <udiDi>04251557100415</udiDi>
    <basicUdiDi>B-04251557100415</basicUdiDi>
    <tradeName>04251557100415</tradeName>
    <deviceName>Anti-TPO kit</deviceName>
    <manufacturerName>Astra Biotech GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000026439</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100301</emdnCode>
    <emdnDescription>THYROID PEROXIDASE (INCL. MICROSOMAL) ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>24-06</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T04:46:13.839Z</lastUpdated>
  </row>
  <row>
    <udiDi>04251557100385</udiDi>
    <basicUdiDi>B-04251557100385</basicUdiDi>
    <tradeName>04251557100385</tradeName>
    <deviceName>Triiodothyronine kit</deviceName>
    <manufacturerName>Astra Biotech GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000026439</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020405</emdnCode>
    <emdnDescription>TRIIODOTHYRONINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>24-04 A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T04:46:12.129Z</lastUpdated>
  </row>
  <row>
    <udiDi>04251557100378</udiDi>
    <basicUdiDi>B-04251557100378</basicUdiDi>
    <tradeName>04251557100378</tradeName>
    <deviceName>Triiodothyronine kit</deviceName>
    <manufacturerName>Astra Biotech GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000026439</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020405</emdnCode>
    <emdnDescription>TRIIODOTHYRONINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>24-04</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T04:46:11.323Z</lastUpdated>
  </row>
  <row>
    <udiDi>04251557100347</udiDi>
    <basicUdiDi>B-04251557100347</basicUdiDi>
    <tradeName>04251557100347</tradeName>
    <deviceName>TSH (third generation) kit</deviceName>
    <manufacturerName>Astra Biotech GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000026439</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020410</emdnCode>
    <emdnDescription>THYROID STIMULATING HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>24-02</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T04:44:22.630Z</lastUpdated>
  </row>
  <row>
    <udiDi>04251557100255</udiDi>
    <basicUdiDi>B-04251557100255</basicUdiDi>
    <tradeName>04251557100255</tradeName>
    <deviceName>Gonadotropin FSH kit</deviceName>
    <manufacturerName>Astra Biotech GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000026439</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050104</emdnCode>
    <emdnDescription>FOLLICLE STIMULATING HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>21-06 A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T04:44:20.230Z</lastUpdated>
  </row>
  <row>
    <udiDi>04251557100248</udiDi>
    <basicUdiDi>B-04251557100248</basicUdiDi>
    <tradeName>04251557100248</tradeName>
    <deviceName>Gonadotropin FSH kit</deviceName>
    <manufacturerName>Astra Biotech GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000026439</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050104</emdnCode>
    <emdnDescription>FOLLICLE STIMULATING HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>21-06</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T04:44:18.631Z</lastUpdated>
  </row>
  <row>
    <udiDi>04251557100217</udiDi>
    <basicUdiDi>B-04251557100217</basicUdiDi>
    <tradeName>04251557100217</tradeName>
    <deviceName>Prolactin kit</deviceName>
    <manufacturerName>Astra Biotech GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000026439</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050108</emdnCode>
    <emdnDescription>PROLACTIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>21-04 A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T04:44:17.825Z</lastUpdated>
  </row>
</eudamedExport>