<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>B502BSB20140</udiDi>
    <basicUdiDi>B-B502BSB20140</basicUdiDi>
    <tradeName>Tinto Neurofilament, EP79, RMab</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bio SB Inc</manufacturerName>
    <manufacturerSrn>US-MF-000036462</manufacturerSrn>
    <authorisedRepresentativeName>QAdvis EAR AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000001599</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BSB 2014</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T00:28:37.454Z</lastUpdated>
  </row>
  <row>
    <udiDi>B502BSB20150</udiDi>
    <basicUdiDi>B-B502BSB20150</basicUdiDi>
    <tradeName>Tinto Neurofilament, EP79, RMab</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bio SB Inc</manufacturerName>
    <manufacturerSrn>US-MF-000036462</manufacturerSrn>
    <authorisedRepresentativeName>QAdvis EAR AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000001599</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BSB 2015</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T00:28:37.434Z</lastUpdated>
  </row>
  <row>
    <udiDi>B502BSB20160</udiDi>
    <basicUdiDi>B-B502BSB20160</basicUdiDi>
    <tradeName>Tinto Neurofilament, EP79, RMab</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bio SB Inc</manufacturerName>
    <manufacturerSrn>US-MF-000036462</manufacturerSrn>
    <authorisedRepresentativeName>QAdvis EAR AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000001599</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BSB 2016</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T00:28:37.416Z</lastUpdated>
  </row>
  <row>
    <udiDi>B502BSB20170</udiDi>
    <basicUdiDi>B-B502BSB20170</basicUdiDi>
    <tradeName>Neurofilament, EP79, RMab</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bio SB Inc</manufacturerName>
    <manufacturerSrn>US-MF-000036462</manufacturerSrn>
    <authorisedRepresentativeName>QAdvis EAR AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000001599</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BSB 2017</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T00:28:37.398Z</lastUpdated>
  </row>
  <row>
    <udiDi>B502BSB20180</udiDi>
    <basicUdiDi>B-B502BSB20180</basicUdiDi>
    <tradeName>Neurofilament, EP79, RMab</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bio SB Inc</manufacturerName>
    <manufacturerSrn>US-MF-000036462</manufacturerSrn>
    <authorisedRepresentativeName>QAdvis EAR AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000001599</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BSB 2018</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T00:28:37.380Z</lastUpdated>
  </row>
  <row>
    <udiDi>B502BSB20190</udiDi>
    <basicUdiDi>B-B502BSB20190</basicUdiDi>
    <tradeName>Neurofilament, EP79, RMab</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bio SB Inc</manufacturerName>
    <manufacturerSrn>US-MF-000036462</manufacturerSrn>
    <authorisedRepresentativeName>QAdvis EAR AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000001599</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BSB 2019</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T00:28:37.358Z</lastUpdated>
  </row>
  <row>
    <udiDi>B502BSB20210</udiDi>
    <basicUdiDi>B-B502BSB20210</basicUdiDi>
    <tradeName>Tinto OCT-2, EP115, RMab</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bio SB Inc</manufacturerName>
    <manufacturerSrn>US-MF-000036462</manufacturerSrn>
    <authorisedRepresentativeName>QAdvis EAR AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000001599</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BSB 2021</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T00:28:37.339Z</lastUpdated>
  </row>
  <row>
    <udiDi>B502BSB20220</udiDi>
    <basicUdiDi>B-B502BSB20220</basicUdiDi>
    <tradeName>Tinto OCT-2, EP115, RMab</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bio SB Inc</manufacturerName>
    <manufacturerSrn>US-MF-000036462</manufacturerSrn>
    <authorisedRepresentativeName>QAdvis EAR AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000001599</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BSB 2022</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T00:28:37.318Z</lastUpdated>
  </row>
  <row>
    <udiDi>B502BSB20230</udiDi>
    <basicUdiDi>B-B502BSB20230</basicUdiDi>
    <tradeName>Tinto OCT-2, EP115, RMab</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bio SB Inc</manufacturerName>
    <manufacturerSrn>US-MF-000036462</manufacturerSrn>
    <authorisedRepresentativeName>QAdvis EAR AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000001599</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BSB 2023</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T00:28:37.298Z</lastUpdated>
  </row>
  <row>
    <udiDi>B502BSB20240</udiDi>
    <basicUdiDi>B-B502BSB20240</basicUdiDi>
    <tradeName>OCT-2, EP115, RMab</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bio SB Inc</manufacturerName>
    <manufacturerSrn>US-MF-000036462</manufacturerSrn>
    <authorisedRepresentativeName>QAdvis EAR AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000001599</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BSB 2024</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T00:28:37.270Z</lastUpdated>
  </row>
  <row>
    <udiDi>B502BSB20250</udiDi>
    <basicUdiDi>B-B502BSB20250</basicUdiDi>
    <tradeName>OCT-2, EP115, RMab</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bio SB Inc</manufacturerName>
    <manufacturerSrn>US-MF-000036462</manufacturerSrn>
    <authorisedRepresentativeName>QAdvis EAR AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000001599</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BSB 2025</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T00:28:37.250Z</lastUpdated>
  </row>
  <row>
    <udiDi>B502BSB20260</udiDi>
    <basicUdiDi>B-B502BSB20260</basicUdiDi>
    <tradeName>OCT-2, EP115, RMab</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bio SB Inc</manufacturerName>
    <manufacturerSrn>US-MF-000036462</manufacturerSrn>
    <authorisedRepresentativeName>QAdvis EAR AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000001599</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BSB 2026</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T00:28:37.228Z</lastUpdated>
  </row>
  <row>
    <udiDi>B502BSB20280</udiDi>
    <basicUdiDi>B-B502BSB20280</basicUdiDi>
    <tradeName>Tinto OCT-4, EP143, RMab</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bio SB Inc</manufacturerName>
    <manufacturerSrn>US-MF-000036462</manufacturerSrn>
    <authorisedRepresentativeName>QAdvis EAR AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000001599</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BSB 2028</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T00:28:37.205Z</lastUpdated>
  </row>
  <row>
    <udiDi>B502BSB20290</udiDi>
    <basicUdiDi>B-B502BSB20290</basicUdiDi>
    <tradeName>Tinto OCT-4, EP143, RMab</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bio SB Inc</manufacturerName>
    <manufacturerSrn>US-MF-000036462</manufacturerSrn>
    <authorisedRepresentativeName>QAdvis EAR AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000001599</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BSB 2029</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T00:28:37.185Z</lastUpdated>
  </row>
  <row>
    <udiDi>B502BSB20300</udiDi>
    <basicUdiDi>B-B502BSB20300</basicUdiDi>
    <tradeName>Tinto OCT-4, EP143, RMab</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bio SB Inc</manufacturerName>
    <manufacturerSrn>US-MF-000036462</manufacturerSrn>
    <authorisedRepresentativeName>QAdvis EAR AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000001599</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BSB 2030</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T00:28:37.163Z</lastUpdated>
  </row>
  <row>
    <udiDi>B502BSB20310</udiDi>
    <basicUdiDi>B-B502BSB20310</basicUdiDi>
    <tradeName>OCT-4, EP143, RMab</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bio SB Inc</manufacturerName>
    <manufacturerSrn>US-MF-000036462</manufacturerSrn>
    <authorisedRepresentativeName>QAdvis EAR AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000001599</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BSB 2031</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T00:28:37.140Z</lastUpdated>
  </row>
  <row>
    <udiDi>B502BSB20320</udiDi>
    <basicUdiDi>B-B502BSB20320</basicUdiDi>
    <tradeName>OCT-4, EP143, RMab</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bio SB Inc</manufacturerName>
    <manufacturerSrn>US-MF-000036462</manufacturerSrn>
    <authorisedRepresentativeName>QAdvis EAR AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000001599</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BSB 2032</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T00:28:37.122Z</lastUpdated>
  </row>
  <row>
    <udiDi>B502BSB20330</udiDi>
    <basicUdiDi>B-B502BSB20330</basicUdiDi>
    <tradeName>OCT-4, EP143, RMab</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bio SB Inc</manufacturerName>
    <manufacturerSrn>US-MF-000036462</manufacturerSrn>
    <authorisedRepresentativeName>QAdvis EAR AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000001599</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BSB 2033</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T00:28:37.101Z</lastUpdated>
  </row>
  <row>
    <udiDi>B502BSB20350</udiDi>
    <basicUdiDi>B-B502BSB20350</basicUdiDi>
    <tradeName>Tinto HER-2 neu, RBT-HER2, RMab</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bio SB Inc</manufacturerName>
    <manufacturerSrn>US-MF-000036462</manufacturerSrn>
    <authorisedRepresentativeName>QAdvis EAR AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000001599</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BSB 2035</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T00:28:37.078Z</lastUpdated>
  </row>
  <row>
    <udiDi>B502BSB20360</udiDi>
    <basicUdiDi>B-B502BSB20360</basicUdiDi>
    <tradeName>Tinto HER-2 neu, RBT-HER2, RMab</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bio SB Inc</manufacturerName>
    <manufacturerSrn>US-MF-000036462</manufacturerSrn>
    <authorisedRepresentativeName>QAdvis EAR AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000001599</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BSB 2036</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T00:28:37.058Z</lastUpdated>
  </row>
</eudamedExport>