<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>B502BSB237130</udiDi>
    <basicUdiDi>B-B502BSB237130</basicUdiDi>
    <tradeName>Tinto PD-L1|CD274, 28-8, 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-2371-3</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T00:28:26.115Z</lastUpdated>
  </row>
  <row>
    <udiDi>B502BSB237170</udiDi>
    <basicUdiDi>B-B502BSB237170</basicUdiDi>
    <tradeName>Tinto PD-L1|CD274, 28-8, 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-2371-7</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T00:28:26.094Z</lastUpdated>
  </row>
  <row>
    <udiDi>B502BSB2372010</udiDi>
    <basicUdiDi>B-B502BSB2372010</basicUdiDi>
    <tradeName>PLA2R1, BSB-129, MMab</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-2372-01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T00:28:26.071Z</lastUpdated>
  </row>
  <row>
    <udiDi>B502BSB2372050</udiDi>
    <basicUdiDi>B-B502BSB2372050</basicUdiDi>
    <tradeName>PLA2R1, BSB-129, MMab</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-2372-05</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T00:28:26.047Z</lastUpdated>
  </row>
  <row>
    <udiDi>B502BSB237210</udiDi>
    <basicUdiDi>B-B502BSB237210</basicUdiDi>
    <tradeName>PLA2R1, BSB-129, MMab</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-2372-1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T00:28:26.029Z</lastUpdated>
  </row>
  <row>
    <udiDi>B502BSB2372150</udiDi>
    <basicUdiDi>B-B502BSB2372150</basicUdiDi>
    <tradeName>Tinto PLA2R1, BSB-129, MMab</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-2372-15</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T00:28:26.010Z</lastUpdated>
  </row>
  <row>
    <udiDi>B502BSB237230</udiDi>
    <basicUdiDi>B-B502BSB237230</basicUdiDi>
    <tradeName>Tinto PLA2R1, BSB-129, MMab</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-2372-3</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T00:28:25.990Z</lastUpdated>
  </row>
  <row>
    <udiDi>B502BSB237270</udiDi>
    <basicUdiDi>B-B502BSB237270</basicUdiDi>
    <tradeName>Tinto PLA2R1, BSB-129, MMab</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-2372-7</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T00:28:25.971Z</lastUpdated>
  </row>
  <row>
    <udiDi>B502BSB2374010</udiDi>
    <basicUdiDi>B-B502BSB2374010</basicUdiDi>
    <tradeName>PRAME, RBT-PRAME, 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-2374-01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T00:28:25.950Z</lastUpdated>
  </row>
  <row>
    <udiDi>B502BSB2374050</udiDi>
    <basicUdiDi>B-B502BSB2374050</basicUdiDi>
    <tradeName>PRAME, RBT-PRAME, 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-2374-05</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T00:28:25.930Z</lastUpdated>
  </row>
  <row>
    <udiDi>B502BSB237410</udiDi>
    <basicUdiDi>B-B502BSB237410</basicUdiDi>
    <tradeName>PRAME, RBT-PRAME, 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-2374-1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T00:28:25.910Z</lastUpdated>
  </row>
  <row>
    <udiDi>B502BSB2374150</udiDi>
    <basicUdiDi>B-B502BSB2374150</basicUdiDi>
    <tradeName>Tinto PRAME, RBT-PRAME, 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-2374-15</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T00:28:25.884Z</lastUpdated>
  </row>
  <row>
    <udiDi>B502BSB237430</udiDi>
    <basicUdiDi>B-B502BSB237430</basicUdiDi>
    <tradeName>Tinto PRAME, RBT-PRAME, 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-2374-3</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T00:28:25.866Z</lastUpdated>
  </row>
  <row>
    <udiDi>B502BSB237470</udiDi>
    <basicUdiDi>B-B502BSB237470</basicUdiDi>
    <tradeName>Tinto PRAME, RBT-PRAME, 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-2374-7</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T00:28:25.847Z</lastUpdated>
  </row>
  <row>
    <udiDi>B502BSB2375010</udiDi>
    <basicUdiDi>B-B502BSB2375010</basicUdiDi>
    <tradeName>SDHB, BSB-131, MMab</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-2375-01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T00:28:25.827Z</lastUpdated>
  </row>
  <row>
    <udiDi>B502BSB2375050</udiDi>
    <basicUdiDi>B-B502BSB2375050</basicUdiDi>
    <tradeName>SDHB, BSB-131, MMab</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-2375-05</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T00:28:25.808Z</lastUpdated>
  </row>
  <row>
    <udiDi>B502BSB237510</udiDi>
    <basicUdiDi>B-B502BSB237510</basicUdiDi>
    <tradeName>SDHB, BSB-131, MMab</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-2375-1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T00:28:25.790Z</lastUpdated>
  </row>
  <row>
    <udiDi>B502BSB2375150</udiDi>
    <basicUdiDi>B-B502BSB2375150</basicUdiDi>
    <tradeName>Tinto SDHB, BSB-131, MMab</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-2375-15</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T00:28:25.769Z</lastUpdated>
  </row>
  <row>
    <udiDi>B502BSB237530</udiDi>
    <basicUdiDi>B-B502BSB237530</basicUdiDi>
    <tradeName>Tinto SDHB, BSB-131, MMab</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-2375-3</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T00:28:25.747Z</lastUpdated>
  </row>
  <row>
    <udiDi>B502BSB237570</udiDi>
    <basicUdiDi>B-B502BSB237570</basicUdiDi>
    <tradeName>Tinto SDHB, BSB-131, MMab</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-2375-7</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T00:28:25.728Z</lastUpdated>
  </row>
</eudamedExport>