<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>05940540386743</udiDi>
    <basicUdiDi>594054038LOWENSTEINJE68FQ</basicUdiDi>
    <tradeName>LOWENSTEIN JENSEN + ETHIONAMIDE 40 µg/mL</tradeName>
    <deviceName>LOWENSTEIN JENSEN + ETHIONAMIDE 40 µg/mL</deviceName>
    <manufacturerName>DELTAROM SRL</manufacturerName>
    <manufacturerSrn>RO-MF-000035924</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104010206</emdnCode>
    <emdnDescription>MEDIA IN TUBES (SOLID &amp; LIQUID)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>342917</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-31T12:34:43.052Z</lastUpdated>
  </row>
  <row>
    <udiDi>05940540386750</udiDi>
    <basicUdiDi>594054038LOWENSTEINJE50F5</basicUdiDi>
    <tradeName>LOWENSTEIN JENSEN + ETHIONAMIDE 35 µg/ml</tradeName>
    <deviceName>LOWENSTEIN JENSEN + ETHIONAMIDE 35 µg/ml</deviceName>
    <manufacturerName>DELTAROM SRL</manufacturerName>
    <manufacturerSrn>RO-MF-000035924</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104010206</emdnCode>
    <emdnDescription>MEDIA IN TUBES (SOLID &amp; LIQUID)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>342907</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-31T12:34:42.265Z</lastUpdated>
  </row>
  <row>
    <udiDi>05940540386736</udiDi>
    <basicUdiDi>594054038LOWENSTEINJENIJV</basicUdiDi>
    <tradeName>LOWENSTEIN JENSEN + ISONIAZID 0.1 µg/mL</tradeName>
    <deviceName>LOWENSTEIN JENSEN + ISONIAZID 0.1 µg/mL</deviceName>
    <manufacturerName>DELTAROM SRL</manufacturerName>
    <manufacturerSrn>RO-MF-000035924</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104010206</emdnCode>
    <emdnDescription>MEDIA IN TUBES (SOLID &amp; LIQUID)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>342927</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-31T12:34:41.450Z</lastUpdated>
  </row>
  <row>
    <udiDi>05940540386729</udiDi>
    <basicUdiDi>594054038LOWENSTEINJ012BR</basicUdiDi>
    <tradeName>LOWENSTEIN JENSEN + ISONIAZID 0.2 µg/mL</tradeName>
    <deviceName>LOWENSTEIN JENSEN + ISONIAZID 0.2 µg/mL</deviceName>
    <manufacturerName>DELTAROM SRL</manufacturerName>
    <manufacturerSrn>RO-MF-000035924</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104010206</emdnCode>
    <emdnDescription>MEDIA IN TUBES (SOLID &amp; LIQUID)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>342937</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-31T12:34:40.655Z</lastUpdated>
  </row>
  <row>
    <udiDi>05940540386712</udiDi>
    <basicUdiDi>594054038LOWENSTEINISONM9</basicUdiDi>
    <tradeName>LOWENSTEIN JENSEN + ISONIAZID 0.20 µg/mL</tradeName>
    <deviceName>LOWENSTEIN JENSEN + ISONIAZID 0.20 µg/mL</deviceName>
    <manufacturerName>DELTAROM SRL</manufacturerName>
    <manufacturerSrn>RO-MF-000035924</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104010206</emdnCode>
    <emdnDescription>MEDIA IN TUBES (SOLID &amp; LIQUID)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>342947</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-31T12:34:36.738Z</lastUpdated>
  </row>
  <row>
    <udiDi>05940540386705</udiDi>
    <basicUdiDi>594054038LOWENSTEINISO0KF</basicUdiDi>
    <tradeName>LOWENSTEIN JENSEN + ISONIAZID 1 µg/mL</tradeName>
    <deviceName>LOWENSTEIN JENSEN + ISONIAZID 1 µg/mL</deviceName>
    <manufacturerName>DELTAROM SRL</manufacturerName>
    <manufacturerSrn>RO-MF-000035924</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104010206</emdnCode>
    <emdnDescription>MEDIA IN TUBES (SOLID &amp; LIQUID)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>342957</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-31T12:34:36.692Z</lastUpdated>
  </row>
  <row>
    <udiDi>05940540386699</udiDi>
    <basicUdiDi>594054038LOWENSTEINISO1KH</basicUdiDi>
    <tradeName>LOWENSTEIN JENSEN + ISONIAZID 1 µg/ml</tradeName>
    <deviceName>LOWENSTEIN JENSEN + ISONIAZID 1 µg/ml</deviceName>
    <manufacturerName>DELTAROM SRL</manufacturerName>
    <manufacturerSrn>RO-MF-000035924</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104010206</emdnCode>
    <emdnDescription>MEDIA IN TUBES (SOLID &amp; LIQUID)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>342967</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-31T12:34:36.681Z</lastUpdated>
  </row>
  <row>
    <udiDi>05940540386682</udiDi>
    <basicUdiDi>594054038LOWENSTEINISO2KK</basicUdiDi>
    <tradeName>LOWENSTEIN JENSEN + ISONIAZID 10 µg/mL</tradeName>
    <deviceName>LOWENSTEIN JENSEN + ISONIAZID 10 µg/mL</deviceName>
    <manufacturerName>DELTAROM SRL</manufacturerName>
    <manufacturerSrn>RO-MF-000035924</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104010206</emdnCode>
    <emdnDescription>MEDIA IN TUBES (SOLID &amp; LIQUID)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>342977</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-31T12:34:36.560Z</lastUpdated>
  </row>
  <row>
    <udiDi>05940540386675</udiDi>
    <basicUdiDi>594054038LOWENSTEINISO3KM</basicUdiDi>
    <tradeName>LOWENSTEIN JENSEN + ISONIAZID 5 µg/mL</tradeName>
    <deviceName>LOWENSTEIN JENSEN + ISONIAZID 5 µg/mL</deviceName>
    <manufacturerName>DELTAROM SRL</manufacturerName>
    <manufacturerSrn>RO-MF-000035924</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104010206</emdnCode>
    <emdnDescription>MEDIA IN TUBES (SOLID &amp; LIQUID)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>342987</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-31T12:34:28.140Z</lastUpdated>
  </row>
  <row>
    <udiDi>05940540386668</udiDi>
    <basicUdiDi>594054038LOWENSTEINKANAHY</basicUdiDi>
    <tradeName>LOWENSTEIN JENSEN + KANAMYCIN 10 µg/mL</tradeName>
    <deviceName>LOWENSTEIN JENSEN + KANAMYCIN 10 µg/mL</deviceName>
    <manufacturerName>DELTAROM SRL</manufacturerName>
    <manufacturerSrn>RO-MF-000035924</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104010206</emdnCode>
    <emdnDescription>MEDIA IN TUBES (SOLID &amp; LIQUID)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>342997</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-31T12:34:27.351Z</lastUpdated>
  </row>
  <row>
    <udiDi>05940540386651</udiDi>
    <basicUdiDi>594054038LOWENSTEINKAN0GY</basicUdiDi>
    <tradeName>LOWENSTEIN JENSEN + KANAMYCIN 20 µg/mL</tradeName>
    <deviceName>LOWENSTEIN JENSEN + KANAMYCIN 20 µg/mL</deviceName>
    <manufacturerName>DELTAROM SRL</manufacturerName>
    <manufacturerSrn>RO-MF-000035924</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104010206</emdnCode>
    <emdnDescription>MEDIA IN TUBES (SOLID &amp; LIQUID)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>343007</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-31T12:34:26.544Z</lastUpdated>
  </row>
  <row>
    <udiDi>05940540386644</udiDi>
    <basicUdiDi>594054038LOWENSTEINKAN1H2</basicUdiDi>
    <tradeName>LOWENSTEIN JENSEN + KANAMYCIN 25 µg/mL</tradeName>
    <deviceName>LOWENSTEIN JENSEN + KANAMYCIN 25 µg/mL</deviceName>
    <manufacturerName>DELTAROM SRL</manufacturerName>
    <manufacturerSrn>RO-MF-000035924</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104010206</emdnCode>
    <emdnDescription>MEDIA IN TUBES (SOLID &amp; LIQUID)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>343017</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-31T12:34:25.742Z</lastUpdated>
  </row>
  <row>
    <udiDi>05940540386637</udiDi>
    <basicUdiDi>594054038LOWENSTEINKAN2H4</basicUdiDi>
    <tradeName>LOWENSTEIN JENSEN + KANAMYCIN 30 µg/mL</tradeName>
    <deviceName>LOWENSTEIN JENSEN + KANAMYCIN 30 µg/mL</deviceName>
    <manufacturerName>DELTAROM SRL</manufacturerName>
    <manufacturerSrn>RO-MF-000035924</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104010206</emdnCode>
    <emdnDescription>MEDIA IN TUBES (SOLID &amp; LIQUID)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>343027</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-31T12:34:21.740Z</lastUpdated>
  </row>
  <row>
    <udiDi>05940540386620</udiDi>
    <basicUdiDi>594054038LOWENSTEINKAN3H6</basicUdiDi>
    <tradeName>LOWENSTEIN JENSEN + KANAMYCIN 35 µg/ml</tradeName>
    <deviceName>LOWENSTEIN JENSEN + KANAMYCIN 35 µg/ml</deviceName>
    <manufacturerName>DELTAROM SRL</manufacturerName>
    <manufacturerSrn>RO-MF-000035924</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104010206</emdnCode>
    <emdnDescription>MEDIA IN TUBES (SOLID &amp; LIQUID)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>343037</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-31T12:34:20.938Z</lastUpdated>
  </row>
  <row>
    <udiDi>05940540386613</udiDi>
    <basicUdiDi>594054038LOWENSTEINNICOKQ</basicUdiDi>
    <tradeName>LOWENSTEIN JENSEN + NICOTINAMIDE 10 µg/mL</tradeName>
    <deviceName>LOWENSTEIN JENSEN + NICOTINAMIDE 10 µg/mL</deviceName>
    <manufacturerName>DELTAROM SRL</manufacturerName>
    <manufacturerSrn>RO-MF-000035924</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104010206</emdnCode>
    <emdnDescription>MEDIA IN TUBES (SOLID &amp; LIQUID)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>343047</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-31T12:34:20.138Z</lastUpdated>
  </row>
  <row>
    <udiDi>05940540386606</udiDi>
    <basicUdiDi>594054038LOWENSTEINNIC0HU</basicUdiDi>
    <tradeName>LOWENSTEIN JENSEN + NICOTINAMIDE 20 µg/mL</tradeName>
    <deviceName>LOWENSTEIN JENSEN + NICOTINAMIDE 20 µg/mL</deviceName>
    <manufacturerName>DELTAROM SRL</manufacturerName>
    <manufacturerSrn>RO-MF-000035924</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104010206</emdnCode>
    <emdnDescription>MEDIA IN TUBES (SOLID &amp; LIQUID)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>343057</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-31T12:34:19.431Z</lastUpdated>
  </row>
  <row>
    <udiDi>05940540386590</udiDi>
    <basicUdiDi>594054038LOWENSTEINNIC1HW</basicUdiDi>
    <tradeName>LOWENSTEIN JENSEN + NICOTINAMIDE 30 µg/mL</tradeName>
    <deviceName>LOWENSTEIN JENSEN + NICOTINAMIDE 30 µg/mL</deviceName>
    <manufacturerName>DELTAROM SRL</manufacturerName>
    <manufacturerSrn>RO-MF-000035924</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104010206</emdnCode>
    <emdnDescription>MEDIA IN TUBES (SOLID &amp; LIQUID)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>343067</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-31T12:33:48.810Z</lastUpdated>
  </row>
  <row>
    <udiDi>05940540386583</udiDi>
    <basicUdiDi>594054038LOWENSTEINOFLOLB</basicUdiDi>
    <tradeName>LOWENSTEIN JENSEN + OFLOXACIN 10 µg/mL</tradeName>
    <deviceName>LOWENSTEIN JENSEN + OFLOXACIN 10 µg/mL</deviceName>
    <manufacturerName>DELTAROM SRL</manufacturerName>
    <manufacturerSrn>RO-MF-000035924</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104010206</emdnCode>
    <emdnDescription>MEDIA IN TUBES (SOLID &amp; LIQUID)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>343077</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-31T12:33:48.017Z</lastUpdated>
  </row>
  <row>
    <udiDi>05940540386576</udiDi>
    <basicUdiDi>594054038LOWENSTEINOFL1JH</basicUdiDi>
    <tradeName>LOWENSTEIN JENSEN + OFLOXACIN 2 µg/ml</tradeName>
    <deviceName>LOWENSTEIN JENSEN + OFLOXACIN 2 µg/ml</deviceName>
    <manufacturerName>DELTAROM SRL</manufacturerName>
    <manufacturerSrn>RO-MF-000035924</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104010206</emdnCode>
    <emdnDescription>MEDIA IN TUBES (SOLID &amp; LIQUID)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>343097</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-31T12:33:47.222Z</lastUpdated>
  </row>
  <row>
    <udiDi>05940540386569</udiDi>
    <basicUdiDi>594054038LOWENSTEINOFL2JK</basicUdiDi>
    <tradeName>LOWENSTEIN JENSEN + OFLOXACIN 20 µg/mL</tradeName>
    <deviceName>LOWENSTEIN JENSEN + OFLOXACIN 20 µg/mL</deviceName>
    <manufacturerName>DELTAROM SRL</manufacturerName>
    <manufacturerSrn>RO-MF-000035924</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104010206</emdnCode>
    <emdnDescription>MEDIA IN TUBES (SOLID &amp; LIQUID)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>343107</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-31T12:33:46.419Z</lastUpdated>
  </row>
</eudamedExport>