<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>B502BSB369370</udiDi>
    <basicUdiDi>B-B502BSB369370</basicUdiDi>
    <tradeName>TintoFast HMB-45, HMB-45, MMab</tradeName>
    <deviceName>TintoFast HMB-45, HMB-45, 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-3693-7</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-12T19:37:15.682Z</lastUpdated>
  </row>
  <row>
    <udiDi>B502BSB369330</udiDi>
    <basicUdiDi>B-B502BSB369330</basicUdiDi>
    <tradeName>TintoFast HMB-45, HMB-45, MMab</tradeName>
    <deviceName>TintoFast HMB-45, HMB-45, 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-3693-3</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-12T19:37:14.080Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806387812845</udiDi>
    <basicUdiDi>B-08806387812845</basicUdiDi>
    <tradeName>ENDOART Gutta Percha Points</tradeName>
    <deviceName></deviceName>
    <manufacturerName>META BIOMED CO., LTD.</manufacturerName>
    <manufacturerSrn>KR-MF-000009681</manufacturerSrn>
    <authorisedRepresentativeName>Meta Biomed Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000004953</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>-</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-12T19:37:13.583Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975551434885</udiDi>
    <basicUdiDi>697555143ClayGelPack6X</basicUdiDi>
    <tradeName>Hot Cold Pack</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jiangsu Yishun Medical Equipment Co.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000030036</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NA</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-12T19:37:13.558Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975551434892</udiDi>
    <basicUdiDi>697555143ClayGelPack6X</basicUdiDi>
    <tradeName>Hot Cold Pack</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jiangsu Yishun Medical Equipment Co.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000030036</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NA</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-12T19:37:13.542Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809728998215</udiDi>
    <basicUdiDi>880972899134Q2</basicUdiDi>
    <tradeName>08809728998215</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MegaGen Implant Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000009885</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AANSAL4015</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-12T19:37:13.521Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809728996310</udiDi>
    <basicUdiDi>880972899134Q2</basicUdiDi>
    <tradeName>08809728996310</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MegaGen Implant Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000009885</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AANSAL4017</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-12T19:37:13.502Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806388203529</udiDi>
    <basicUdiDi>880972899134Q2</basicUdiDi>
    <tradeName>08806388203529</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MegaGen Implant Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000009885</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AANSAL4024</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-12T19:37:13.480Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975551434908</udiDi>
    <basicUdiDi>697555143ClayGelPack6X</basicUdiDi>
    <tradeName>Hot Cold Pack</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jiangsu Yishun Medical Equipment Co.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000030036</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NA</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-12T19:37:13.449Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806388203536</udiDi>
    <basicUdiDi>880972899134Q2</basicUdiDi>
    <tradeName>08806388203536</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MegaGen Implant Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000009885</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AANSAL4025</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-12T19:37:13.433Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806388203543</udiDi>
    <basicUdiDi>880972899134Q2</basicUdiDi>
    <tradeName>08806388203543</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MegaGen Implant Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000009885</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AANSAL4027</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-12T19:37:13.408Z</lastUpdated>
  </row>
  <row>
    <udiDi>B502BSB3693150</udiDi>
    <basicUdiDi>B-B502BSB3693150</basicUdiDi>
    <tradeName>TintoFast HMB-45, HMB-45, MMab</tradeName>
    <deviceName>TintoFast HMB-45, HMB-45, 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-3693-15</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-12T19:37:13.404Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975551435219</udiDi>
    <basicUdiDi>697555143ClayGelPack6X</basicUdiDi>
    <tradeName>Hot Cold Pack</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jiangsu Yishun Medical Equipment Co.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000030036</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NA</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-12T19:37:13.380Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806388203550</udiDi>
    <basicUdiDi>880972899134Q2</basicUdiDi>
    <tradeName>08806388203550</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MegaGen Implant Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000009885</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AANSAL4034</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-12T19:37:13.356Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806388203567</udiDi>
    <basicUdiDi>880972899134Q2</basicUdiDi>
    <tradeName>08806388203567</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MegaGen Implant Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000009885</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AANSAL4035</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-12T19:37:13.330Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806388203574</udiDi>
    <basicUdiDi>880972899134Q2</basicUdiDi>
    <tradeName>08806388203574</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MegaGen Implant Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000009885</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AANSAL4037</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-12T19:37:13.302Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806388203581</udiDi>
    <basicUdiDi>880972899134Q2</basicUdiDi>
    <tradeName>08806388203581</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MegaGen Implant Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000009885</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AANSAL4044</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-12T19:37:13.279Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806388203598</udiDi>
    <basicUdiDi>880972899134Q2</basicUdiDi>
    <tradeName>08806388203598</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MegaGen Implant Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000009885</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AANSAL4045</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-12T19:37:13.255Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975551434922</udiDi>
    <basicUdiDi>697555143GelSleeveMV</basicUdiDi>
    <tradeName>Gel Sleeve</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jiangsu Yishun Medical Equipment Co.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000030036</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NA</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-12T19:37:13.231Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806388203604</udiDi>
    <basicUdiDi>880972899134Q2</basicUdiDi>
    <tradeName>08806388203604</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MegaGen Implant Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000009885</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AANSAL4047</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-12T19:37:13.208Z</lastUpdated>
  </row>
</eudamedExport>