<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>B502BSB58530</udiDi>
    <basicUdiDi>B-B502BSB58530</basicUdiDi>
    <tradeName>p63, EP174, RMab</tradeName>
    <deviceName>p63, EP174, RMab</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>IVDD</legislation>
    <emdnCode>W01030709</emdnCode>
    <emdnDescription>PRIMARY ANTISERA FOR IMMUNOHISTOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BSB 5853</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-12T20:26:41.060Z</lastUpdated>
  </row>
  <row>
    <udiDi>B502BSB58520</udiDi>
    <basicUdiDi>B-B502BSB58520</basicUdiDi>
    <tradeName>p63, EP174, RMab</tradeName>
    <deviceName>p63, EP174, RMab</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>IVDD</legislation>
    <emdnCode>W01030709</emdnCode>
    <emdnDescription>PRIMARY ANTISERA FOR IMMUNOHISTOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BSB 5852</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-12T20:26:40.257Z</lastUpdated>
  </row>
  <row>
    <udiDi>B502BSB58510</udiDi>
    <basicUdiDi>B-B502BSB58510</basicUdiDi>
    <tradeName>p63, EP174, RMab</tradeName>
    <deviceName>p63, EP174, RMab</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>IVDD</legislation>
    <emdnCode>W01030709</emdnCode>
    <emdnDescription>PRIMARY ANTISERA FOR IMMUNOHISTOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BSB 5851</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-12T20:26:39.456Z</lastUpdated>
  </row>
  <row>
    <udiDi>B502BSB58500</udiDi>
    <basicUdiDi>B-B502BSB58500</basicUdiDi>
    <tradeName>Tinto p63, EP174, RMab</tradeName>
    <deviceName>Tinto p63, EP174, RMab</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>IVDD</legislation>
    <emdnCode>W01030709</emdnCode>
    <emdnDescription>PRIMARY ANTISERA FOR IMMUNOHISTOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BSB 5850</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-12T20:26:38.655Z</lastUpdated>
  </row>
  <row>
    <udiDi>B502BSB58490</udiDi>
    <basicUdiDi>B-B502BSB58490</basicUdiDi>
    <tradeName>Tinto p63, EP174, RMab</tradeName>
    <deviceName>Tinto p63, EP174, RMab</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>IVDD</legislation>
    <emdnCode>W01030709</emdnCode>
    <emdnDescription>PRIMARY ANTISERA FOR IMMUNOHISTOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BSB 5849</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-12T20:26:35.394Z</lastUpdated>
  </row>
  <row>
    <udiDi>B502BSB58480</udiDi>
    <basicUdiDi>B-B502BSB58480</basicUdiDi>
    <tradeName>Tinto p63, EP174, RMab</tradeName>
    <deviceName>Tinto p63, EP174, RMab</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>IVDD</legislation>
    <emdnCode>W01030709</emdnCode>
    <emdnDescription>PRIMARY ANTISERA FOR IMMUNOHISTOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BSB 5848</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-12T20:26:34.206Z</lastUpdated>
  </row>
  <row>
    <udiDi>B502BSB58460</udiDi>
    <basicUdiDi>B-B502BSB58460</basicUdiDi>
    <tradeName>p53, DO7, MMab</tradeName>
    <deviceName>p53, DO7, MMab</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>IVDD</legislation>
    <emdnCode>W01030709</emdnCode>
    <emdnDescription>PRIMARY ANTISERA FOR IMMUNOHISTOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BSB 5846</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-12T20:26:33.052Z</lastUpdated>
  </row>
  <row>
    <udiDi>B502BSB58450</udiDi>
    <basicUdiDi>B-B502BSB58450</basicUdiDi>
    <tradeName>p53, DO7, MMab</tradeName>
    <deviceName>p53, DO7, MMab</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>IVDD</legislation>
    <emdnCode>W01030709</emdnCode>
    <emdnDescription>PRIMARY ANTISERA FOR IMMUNOHISTOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BSB 5845</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-12T20:26:32.304Z</lastUpdated>
  </row>
  <row>
    <udiDi>B502BSB58440</udiDi>
    <basicUdiDi>B-B502BSB58440</basicUdiDi>
    <tradeName>p53, DO7, MMab</tradeName>
    <deviceName>p53, DO7, MMab</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>IVDD</legislation>
    <emdnCode>W01030709</emdnCode>
    <emdnDescription>PRIMARY ANTISERA FOR IMMUNOHISTOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BSB 5844</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-12T20:26:27.459Z</lastUpdated>
  </row>
  <row>
    <udiDi>B502BSB58430</udiDi>
    <basicUdiDi>B-B502BSB58430</basicUdiDi>
    <tradeName>Tinto p53, DO7, MMab</tradeName>
    <deviceName>Tinto p53, DO7, MMab</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>IVDD</legislation>
    <emdnCode>W01030709</emdnCode>
    <emdnDescription>PRIMARY ANTISERA FOR IMMUNOHISTOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BSB 5843</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-12T20:26:26.651Z</lastUpdated>
  </row>
  <row>
    <udiDi>B502BSB58420</udiDi>
    <basicUdiDi>B-B502BSB58420</basicUdiDi>
    <tradeName>Tinto p53, DO7, MMab</tradeName>
    <deviceName>Tinto p53, DO7, MMab</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>IVDD</legislation>
    <emdnCode>W01030709</emdnCode>
    <emdnDescription>PRIMARY ANTISERA FOR IMMUNOHISTOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BSB 5842</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-12T20:26:25.854Z</lastUpdated>
  </row>
  <row>
    <udiDi>B502BSB58410</udiDi>
    <basicUdiDi>B-B502BSB58410</basicUdiDi>
    <tradeName>Tinto p53, DO7, MMab</tradeName>
    <deviceName>Tinto p53, DO7, MMab</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>IVDD</legislation>
    <emdnCode>W01030709</emdnCode>
    <emdnDescription>PRIMARY ANTISERA FOR IMMUNOHISTOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BSB 5841</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-12T20:26:25.251Z</lastUpdated>
  </row>
  <row>
    <udiDi>B502BSB58390</udiDi>
    <basicUdiDi>B-B502BSB58390</basicUdiDi>
    <tradeName>p27, SX53G8, MMab</tradeName>
    <deviceName>p27, SX53G8, MMab</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>IVDD</legislation>
    <emdnCode>W01030709</emdnCode>
    <emdnDescription>PRIMARY ANTISERA FOR IMMUNOHISTOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BSB 5839</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-12T20:26:21.044Z</lastUpdated>
  </row>
  <row>
    <udiDi>B502BSB58380</udiDi>
    <basicUdiDi>B-B502BSB58380</basicUdiDi>
    <tradeName>p27, SX53G8, MMab</tradeName>
    <deviceName>p27, SX53G8, MMab</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>IVDD</legislation>
    <emdnCode>W01030709</emdnCode>
    <emdnDescription>PRIMARY ANTISERA FOR IMMUNOHISTOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BSB 5838</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-12T20:26:20.248Z</lastUpdated>
  </row>
  <row>
    <udiDi>B502BSB58370</udiDi>
    <basicUdiDi>B-B502BSB58370</basicUdiDi>
    <tradeName>p27, SX53G8, MMab</tradeName>
    <deviceName>p27, SX53G8, MMab</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>IVDD</legislation>
    <emdnCode>W01030709</emdnCode>
    <emdnDescription>PRIMARY ANTISERA FOR IMMUNOHISTOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BSB 5837</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-12T20:26:19.451Z</lastUpdated>
  </row>
  <row>
    <udiDi>B502BSB58360</udiDi>
    <basicUdiDi>B-B502BSB58360</basicUdiDi>
    <tradeName>Tinto p27, SX53G8, MMab</tradeName>
    <deviceName>Tinto p27, SX53G8, MMab</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>IVDD</legislation>
    <emdnCode>W01030709</emdnCode>
    <emdnDescription>PRIMARY ANTISERA FOR IMMUNOHISTOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BSB 5836</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-12T20:26:18.646Z</lastUpdated>
  </row>
  <row>
    <udiDi>B502BSB58350</udiDi>
    <basicUdiDi>B-B502BSB58350</basicUdiDi>
    <tradeName>Tinto p27, SX53G8, MMab</tradeName>
    <deviceName>Tinto p27, SX53G8, MMab</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>IVDD</legislation>
    <emdnCode>W01030709</emdnCode>
    <emdnDescription>PRIMARY ANTISERA FOR IMMUNOHISTOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BSB 5835</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-12T20:26:14.644Z</lastUpdated>
  </row>
  <row>
    <udiDi>B502BSB58340</udiDi>
    <basicUdiDi>B-B502BSB58340</basicUdiDi>
    <tradeName>Tinto p27, SX53G8, MMab</tradeName>
    <deviceName>Tinto p27, SX53G8, MMab</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>IVDD</legislation>
    <emdnCode>W01030709</emdnCode>
    <emdnDescription>PRIMARY ANTISERA FOR IMMUNOHISTOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BSB 5834</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-12T20:26:13.860Z</lastUpdated>
  </row>
  <row>
    <udiDi>B502BSB58320</udiDi>
    <basicUdiDi>B-B502BSB58320</basicUdiDi>
    <tradeName>p16, 16P04, JC2, MMab</tradeName>
    <deviceName>p16, 16P04, JC2, MMab</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>IVDD</legislation>
    <emdnCode>W01030709</emdnCode>
    <emdnDescription>PRIMARY ANTISERA FOR IMMUNOHISTOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BSB 5832</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-12T20:26:13.163Z</lastUpdated>
  </row>
  <row>
    <udiDi>B502BSB58310</udiDi>
    <basicUdiDi>B-B502BSB58310</basicUdiDi>
    <tradeName>p16, 16P04, JC2, MMab</tradeName>
    <deviceName>p16, 16P04, JC2, MMab</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>IVDD</legislation>
    <emdnCode>W01030709</emdnCode>
    <emdnDescription>PRIMARY ANTISERA FOR IMMUNOHISTOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BSB 5831</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-12T20:26:11.453Z</lastUpdated>
  </row>
</eudamedExport>