<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>B502BSB22620</udiDi>
    <basicUdiDi>B-B502BSB22620</basicUdiDi>
    <tradeName>TCR Beta, BSB-117, 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 2262</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T00:28:27.436Z</lastUpdated>
  </row>
  <row>
    <udiDi>B502BSB22630</udiDi>
    <basicUdiDi>B-B502BSB22630</basicUdiDi>
    <tradeName>TCR Beta, BSB-117, 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 2263</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T00:28:27.414Z</lastUpdated>
  </row>
  <row>
    <udiDi>B502BSB22650</udiDi>
    <basicUdiDi>B-B502BSB22650</basicUdiDi>
    <tradeName>Tinto TdT, RBT-TdT, 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 2265</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T00:28:27.395Z</lastUpdated>
  </row>
  <row>
    <udiDi>B502BSB22660</udiDi>
    <basicUdiDi>B-B502BSB22660</basicUdiDi>
    <tradeName>Tinto TdT, RBT-TdT, 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 2266</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T00:28:27.374Z</lastUpdated>
  </row>
  <row>
    <udiDi>B502BSB22670</udiDi>
    <basicUdiDi>B-B502BSB22670</basicUdiDi>
    <tradeName>Tinto TdT, RBT-TdT, 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 2267</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T00:28:27.348Z</lastUpdated>
  </row>
  <row>
    <udiDi>B502BSB22680</udiDi>
    <basicUdiDi>B-B502BSB22680</basicUdiDi>
    <tradeName>TdT, RBT-TdT, 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 2268</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T00:28:27.328Z</lastUpdated>
  </row>
  <row>
    <udiDi>B502BSB22690</udiDi>
    <basicUdiDi>B-B502BSB22690</basicUdiDi>
    <tradeName>TdT, RBT-TdT, 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 2269</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T00:28:27.309Z</lastUpdated>
  </row>
  <row>
    <udiDi>B502BSB22700</udiDi>
    <basicUdiDi>B-B502BSB22700</basicUdiDi>
    <tradeName>TdT, RBT-TdT, 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 2270</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T00:28:27.290Z</lastUpdated>
  </row>
  <row>
    <udiDi>B502BSB22860</udiDi>
    <basicUdiDi>B-B502BSB22860</basicUdiDi>
    <tradeName>Tinto Uroplakin III, Polyclonal, RPab</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 2286</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T00:28:27.268Z</lastUpdated>
  </row>
  <row>
    <udiDi>B502BSB22870</udiDi>
    <basicUdiDi>B-B502BSB22870</basicUdiDi>
    <tradeName>Tinto Uroplakin III, Polyclonal, RPab</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 2287</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T00:28:27.246Z</lastUpdated>
  </row>
  <row>
    <udiDi>B502BSB22880</udiDi>
    <basicUdiDi>B-B502BSB22880</basicUdiDi>
    <tradeName>Tinto Uroplakin III, Polyclonal, RPab</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 2288</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T00:28:27.223Z</lastUpdated>
  </row>
  <row>
    <udiDi>B502BSB22890</udiDi>
    <basicUdiDi>B-B502BSB22890</basicUdiDi>
    <tradeName>Uroplakin III, Polyclonal, RPab</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 2289</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T00:28:27.204Z</lastUpdated>
  </row>
  <row>
    <udiDi>B502BSB22900</udiDi>
    <basicUdiDi>B-B502BSB22900</basicUdiDi>
    <tradeName>Uroplakin III, Polyclonal, RPab</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 2290</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T00:28:27.179Z</lastUpdated>
  </row>
  <row>
    <udiDi>B502BSB22910</udiDi>
    <basicUdiDi>B-B502BSB22910</basicUdiDi>
    <tradeName>Uroplakin III, Polyclonal, RPab</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 2291</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T00:28:27.155Z</lastUpdated>
  </row>
  <row>
    <udiDi>B502BSB23000</udiDi>
    <basicUdiDi>B-B502BSB23000</basicUdiDi>
    <tradeName>Tinto Villin, EP163, 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 2300</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T00:28:27.135Z</lastUpdated>
  </row>
  <row>
    <udiDi>B502BSB23010</udiDi>
    <basicUdiDi>B-B502BSB23010</basicUdiDi>
    <tradeName>Tinto Villin, EP163, 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 2301</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T00:28:27.115Z</lastUpdated>
  </row>
  <row>
    <udiDi>B502BSB23020</udiDi>
    <basicUdiDi>B-B502BSB23020</basicUdiDi>
    <tradeName>Tinto Villin, EP163, 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 2302</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T00:28:27.096Z</lastUpdated>
  </row>
  <row>
    <udiDi>B502BSB23030</udiDi>
    <basicUdiDi>B-B502BSB23030</basicUdiDi>
    <tradeName>Villin, EP163, 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 2303</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T00:28:27.071Z</lastUpdated>
  </row>
  <row>
    <udiDi>B502BSB23040</udiDi>
    <basicUdiDi>B-B502BSB23040</basicUdiDi>
    <tradeName>Villin, EP163, 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 2304</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T00:28:27.049Z</lastUpdated>
  </row>
  <row>
    <udiDi>B502BSB23050</udiDi>
    <basicUdiDi>B-B502BSB23050</basicUdiDi>
    <tradeName>Villin, EP163, 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 2305</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T00:28:27.023Z</lastUpdated>
  </row>
</eudamedExport>