<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>B502BSB23300</udiDi>
    <basicUdiDi>B-B502BSB23300</basicUdiDi>
    <tradeName>Tinto Glucagon, EP74, 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 2330</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T00:28:26.529Z</lastUpdated>
  </row>
  <row>
    <udiDi>B502BSB23310</udiDi>
    <basicUdiDi>B-B502BSB23310</basicUdiDi>
    <tradeName>Glucagon, EP74, 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 2331</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T00:28:26.506Z</lastUpdated>
  </row>
  <row>
    <udiDi>B502BSB23320</udiDi>
    <basicUdiDi>B-B502BSB23320</basicUdiDi>
    <tradeName>Glucagon, EP74, 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 2332</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T00:28:26.483Z</lastUpdated>
  </row>
  <row>
    <udiDi>B502BSB23330</udiDi>
    <basicUdiDi>B-B502BSB23330</basicUdiDi>
    <tradeName>Glucagon, EP74, 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 2333</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T00:28:26.460Z</lastUpdated>
  </row>
  <row>
    <udiDi>B502BSB23490</udiDi>
    <basicUdiDi>B-B502BSB23490</basicUdiDi>
    <tradeName>Tinto PDGFR-B, RBT-PDGFRB, 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 2349</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T00:28:26.437Z</lastUpdated>
  </row>
  <row>
    <udiDi>B502BSB23500</udiDi>
    <basicUdiDi>B-B502BSB23500</basicUdiDi>
    <tradeName>Tinto PDGFR-B, RBT-PDGFRB, 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 2350</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T00:28:26.415Z</lastUpdated>
  </row>
  <row>
    <udiDi>B502BSB23510</udiDi>
    <basicUdiDi>B-B502BSB23510</basicUdiDi>
    <tradeName>Tinto PDGFR-B, RBT-PDGFRB, 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 2351</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T00:28:26.392Z</lastUpdated>
  </row>
  <row>
    <udiDi>B502BSB23520</udiDi>
    <basicUdiDi>B-B502BSB23520</basicUdiDi>
    <tradeName>PDGFR-B, RBT-PDGFRB, 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 2352</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T00:28:26.370Z</lastUpdated>
  </row>
  <row>
    <udiDi>B502BSB23530</udiDi>
    <basicUdiDi>B-B502BSB23530</basicUdiDi>
    <tradeName>PDGFR-B, RBT-PDGFRB, 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 2353</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T00:28:26.348Z</lastUpdated>
  </row>
  <row>
    <udiDi>B502BSB23540</udiDi>
    <basicUdiDi>B-B502BSB23540</basicUdiDi>
    <tradeName>PDGFR-B, RBT-PDGFRB, 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 2354</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T00:28:26.328Z</lastUpdated>
  </row>
  <row>
    <udiDi>B502BSB2370010</udiDi>
    <basicUdiDi>B-B502BSB2370010</basicUdiDi>
    <tradeName>BCOR, BSB-128, 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-2370-01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T00:28:26.312Z</lastUpdated>
  </row>
  <row>
    <udiDi>B502BSB2370050</udiDi>
    <basicUdiDi>B-B502BSB2370050</basicUdiDi>
    <tradeName>BCOR, BSB-128, 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-2370-05</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T00:28:26.298Z</lastUpdated>
  </row>
  <row>
    <udiDi>B502BSB237010</udiDi>
    <basicUdiDi>B-B502BSB237010</basicUdiDi>
    <tradeName>BCOR, BSB-128, 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-2370-1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T00:28:26.280Z</lastUpdated>
  </row>
  <row>
    <udiDi>B502BSB2370150</udiDi>
    <basicUdiDi>B-B502BSB2370150</basicUdiDi>
    <tradeName>Tinto BCOR, BSB-128, 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-2370-15</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T00:28:26.261Z</lastUpdated>
  </row>
  <row>
    <udiDi>B502BSB237030</udiDi>
    <basicUdiDi>B-B502BSB237030</basicUdiDi>
    <tradeName>Tinto BCOR, BSB-128, 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-2370-3</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T00:28:26.240Z</lastUpdated>
  </row>
  <row>
    <udiDi>B502BSB237070</udiDi>
    <basicUdiDi>B-B502BSB237070</basicUdiDi>
    <tradeName>Tinto BCOR, BSB-128, 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-2370-7</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T00:28:26.219Z</lastUpdated>
  </row>
  <row>
    <udiDi>B502BSB2371010</udiDi>
    <basicUdiDi>B-B502BSB2371010</basicUdiDi>
    <tradeName>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-2371-01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T00:28:26.196Z</lastUpdated>
  </row>
  <row>
    <udiDi>B502BSB2371050</udiDi>
    <basicUdiDi>B-B502BSB2371050</basicUdiDi>
    <tradeName>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-2371-05</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T00:28:26.172Z</lastUpdated>
  </row>
  <row>
    <udiDi>B502BSB237110</udiDi>
    <basicUdiDi>B-B502BSB237110</basicUdiDi>
    <tradeName>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-2371-1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T00:28:26.154Z</lastUpdated>
  </row>
  <row>
    <udiDi>B502BSB2371150</udiDi>
    <basicUdiDi>B-B502BSB2371150</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-2371-15</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T00:28:26.134Z</lastUpdated>
  </row>
</eudamedExport>