<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06948318945450</udiDi>
    <basicUdiDi>694831892a005MD</basicUdiDi>
    <tradeName>06948318945450</tradeName>
    <deviceName>Single-Use Balloon Dilatation Catheter</deviceName>
    <manufacturerName>Anrei Medical (HZ) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009964</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G03020101</emdnCode>
    <emdnDescription>DIGESTIVE ENDOSCOPY, SINGLE-LUMEN NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WBC-22-240-OC55</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-06-28T00:49:58.447Z</lastUpdated>
  </row>
  <row>
    <udiDi>06948318945443</udiDi>
    <basicUdiDi>694831892a005MD</basicUdiDi>
    <tradeName>06948318945443</tradeName>
    <deviceName>Single-Use Balloon Dilatation Catheter</deviceName>
    <manufacturerName>Anrei Medical (HZ) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009964</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G03020101</emdnCode>
    <emdnDescription>DIGESTIVE ENDOSCOPY, SINGLE-LUMEN NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WBC-22-240-OB55</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-06-28T00:49:57.225Z</lastUpdated>
  </row>
  <row>
    <udiDi>06948318945436</udiDi>
    <basicUdiDi>694831892a005MD</basicUdiDi>
    <tradeName>06948318945436</tradeName>
    <deviceName>Single-Use Balloon Dilatation Catheter</deviceName>
    <manufacturerName>Anrei Medical (HZ) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009964</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G03020101</emdnCode>
    <emdnDescription>DIGESTIVE ENDOSCOPY, SINGLE-LUMEN NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WBC-22-240-OA55</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-06-28T00:49:50.011Z</lastUpdated>
  </row>
  <row>
    <udiDi>06948318945368</udiDi>
    <basicUdiDi>694831892a005MD</basicUdiDi>
    <tradeName>06948318945368</tradeName>
    <deviceName>Single-Use Balloon Dilatation Catheter</deviceName>
    <manufacturerName>Anrei Medical (HZ) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009964</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G03020101</emdnCode>
    <emdnDescription>DIGESTIVE ENDOSCOPY, SINGLE-LUMEN NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WBC-22-180-OF55</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-06-28T00:49:48.810Z</lastUpdated>
  </row>
  <row>
    <udiDi>06948318945351</udiDi>
    <basicUdiDi>694831892a005MD</basicUdiDi>
    <tradeName>06948318945351</tradeName>
    <deviceName>Single-Use Balloon Dilatation Catheter</deviceName>
    <manufacturerName>Anrei Medical (HZ) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009964</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G03020101</emdnCode>
    <emdnDescription>DIGESTIVE ENDOSCOPY, SINGLE-LUMEN NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WBC-22-180-OE55</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-06-28T00:49:47.608Z</lastUpdated>
  </row>
  <row>
    <udiDi>06948318945344</udiDi>
    <basicUdiDi>694831892a005MD</basicUdiDi>
    <tradeName>06948318945344</tradeName>
    <deviceName>Single-Use Balloon Dilatation Catheter</deviceName>
    <manufacturerName>Anrei Medical (HZ) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009964</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G03020101</emdnCode>
    <emdnDescription>DIGESTIVE ENDOSCOPY, SINGLE-LUMEN NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WBC-22-180-OD55</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-06-28T00:49:46.410Z</lastUpdated>
  </row>
  <row>
    <udiDi>06948318945337</udiDi>
    <basicUdiDi>694831892a005MD</basicUdiDi>
    <tradeName>06948318945337</tradeName>
    <deviceName>Single-Use Balloon Dilatation Catheter</deviceName>
    <manufacturerName>Anrei Medical (HZ) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009964</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G03020101</emdnCode>
    <emdnDescription>DIGESTIVE ENDOSCOPY, SINGLE-LUMEN NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WBC-22-180-OC55</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-06-28T00:49:40.405Z</lastUpdated>
  </row>
  <row>
    <udiDi>06948318945320</udiDi>
    <basicUdiDi>694831892a005MD</basicUdiDi>
    <tradeName>06948318945320</tradeName>
    <deviceName>Single-Use Balloon Dilatation Catheter</deviceName>
    <manufacturerName>Anrei Medical (HZ) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009964</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G03020101</emdnCode>
    <emdnDescription>DIGESTIVE ENDOSCOPY, SINGLE-LUMEN NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WBC-22-180-OB55</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-06-28T00:49:39.203Z</lastUpdated>
  </row>
  <row>
    <udiDi>06948318945313</udiDi>
    <basicUdiDi>694831892a005MD</basicUdiDi>
    <tradeName>06948318945313</tradeName>
    <deviceName>Single-Use Balloon Dilatation Catheter</deviceName>
    <manufacturerName>Anrei Medical (HZ) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009964</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G03020101</emdnCode>
    <emdnDescription>DIGESTIVE ENDOSCOPY, SINGLE-LUMEN NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WBC-22-180-OA55</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-06-28T00:49:38.100Z</lastUpdated>
  </row>
  <row>
    <udiDi>06948318944880</udiDi>
    <basicUdiDi>694831892a005MD</basicUdiDi>
    <tradeName>06948318944880</tradeName>
    <deviceName>Single-Use Balloon Dilatation Catheter</deviceName>
    <manufacturerName>Anrei Medical (HZ) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009964</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G03020101</emdnCode>
    <emdnDescription>DIGESTIVE ENDOSCOPY, SINGLE-LUMEN NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TBQ-22-190-0440</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-06-28T00:49:35.601Z</lastUpdated>
  </row>
  <row>
    <udiDi>06948318944873</udiDi>
    <basicUdiDi>694831892a005MD</basicUdiDi>
    <tradeName>06948318944873</tradeName>
    <deviceName>Single-Use Balloon Dilatation Catheter</deviceName>
    <manufacturerName>Anrei Medical (HZ) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009964</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G03020101</emdnCode>
    <emdnDescription>DIGESTIVE ENDOSCOPY, SINGLE-LUMEN NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TBQ-22-190-0420</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-06-28T00:49:29.620Z</lastUpdated>
  </row>
  <row>
    <udiDi>06948318944750</udiDi>
    <basicUdiDi>694831892a006MF</basicUdiDi>
    <tradeName>06948318944750</tradeName>
    <deviceName>Sclerotherapy Needle</deviceName>
    <manufacturerName>Anrei Medical (HZ) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009964</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G03020101</emdnCode>
    <emdnDescription>DIGESTIVE ENDOSCOPY, SINGLE-LUMEN NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AMHNE-2423-1904C</reference>
    <placedOnMarketCountry>Croatia</placedOnMarketCountry>
    <lastUpdated>2026-06-28T00:49:28.398Z</lastUpdated>
  </row>
  <row>
    <udiDi>06948318944743</udiDi>
    <basicUdiDi>694831892a006MF</basicUdiDi>
    <tradeName>06948318944743</tradeName>
    <deviceName>Sclerotherapy Needle</deviceName>
    <manufacturerName>Anrei Medical (HZ) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009964</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G03020101</emdnCode>
    <emdnDescription>DIGESTIVE ENDOSCOPY, SINGLE-LUMEN NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AMHNE-2420-1904C</reference>
    <placedOnMarketCountry>Croatia</placedOnMarketCountry>
    <lastUpdated>2026-06-28T00:49:27.201Z</lastUpdated>
  </row>
  <row>
    <udiDi>06948318944736</udiDi>
    <basicUdiDi>694831892a006MF</basicUdiDi>
    <tradeName>06948318944736</tradeName>
    <deviceName>Sclerotherapy Needle</deviceName>
    <manufacturerName>Anrei Medical (HZ) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009964</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G03020101</emdnCode>
    <emdnDescription>DIGESTIVE ENDOSCOPY, SINGLE-LUMEN NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AMHNE-2418-1904C</reference>
    <placedOnMarketCountry>Croatia</placedOnMarketCountry>
    <lastUpdated>2026-06-28T00:49:26.000Z</lastUpdated>
  </row>
  <row>
    <udiDi>06948318944729</udiDi>
    <basicUdiDi>694831892a006MF</basicUdiDi>
    <tradeName>06948318944729</tradeName>
    <deviceName>Sclerotherapy Needle</deviceName>
    <manufacturerName>Anrei Medical (HZ) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009964</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G03020101</emdnCode>
    <emdnDescription>DIGESTIVE ENDOSCOPY, SINGLE-LUMEN NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AMHNE-2423-1906C</reference>
    <placedOnMarketCountry>Croatia</placedOnMarketCountry>
    <lastUpdated>2026-06-28T00:49:18.795Z</lastUpdated>
  </row>
  <row>
    <udiDi>06948318944712</udiDi>
    <basicUdiDi>694831892a006MF</basicUdiDi>
    <tradeName>06948318944712</tradeName>
    <deviceName>Sclerotherapy Needle</deviceName>
    <manufacturerName>Anrei Medical (HZ) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009964</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G03020101</emdnCode>
    <emdnDescription>DIGESTIVE ENDOSCOPY, SINGLE-LUMEN NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AMHNE-2420-1906C</reference>
    <placedOnMarketCountry>Croatia</placedOnMarketCountry>
    <lastUpdated>2026-06-28T00:49:17.596Z</lastUpdated>
  </row>
  <row>
    <udiDi>06948318944705</udiDi>
    <basicUdiDi>694831892a006MF</basicUdiDi>
    <tradeName>06948318944705</tradeName>
    <deviceName>Sclerotherapy Needle</deviceName>
    <manufacturerName>Anrei Medical (HZ) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009964</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G03020101</emdnCode>
    <emdnDescription>DIGESTIVE ENDOSCOPY, SINGLE-LUMEN NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AMHNE-2418-1906C</reference>
    <placedOnMarketCountry>Croatia</placedOnMarketCountry>
    <lastUpdated>2026-06-28T00:49:16.394Z</lastUpdated>
  </row>
  <row>
    <udiDi>06948318944699</udiDi>
    <basicUdiDi>694831892a006MF</basicUdiDi>
    <tradeName>06948318944699</tradeName>
    <deviceName>Sclerotherapy Needle</deviceName>
    <manufacturerName>Anrei Medical (HZ) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009964</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G03020101</emdnCode>
    <emdnDescription>DIGESTIVE ENDOSCOPY, SINGLE-LUMEN NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AMHNE-2423-2104C</reference>
    <placedOnMarketCountry>Croatia</placedOnMarketCountry>
    <lastUpdated>2026-06-28T00:49:15.195Z</lastUpdated>
  </row>
  <row>
    <udiDi>06948318944682</udiDi>
    <basicUdiDi>694831892a006MF</basicUdiDi>
    <tradeName>06948318944682</tradeName>
    <deviceName>Sclerotherapy Needle</deviceName>
    <manufacturerName>Anrei Medical (HZ) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009964</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G03020101</emdnCode>
    <emdnDescription>DIGESTIVE ENDOSCOPY, SINGLE-LUMEN NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AMHNE-2420-2104C</reference>
    <placedOnMarketCountry>Croatia</placedOnMarketCountry>
    <lastUpdated>2026-06-28T00:49:09.442Z</lastUpdated>
  </row>
  <row>
    <udiDi>06948318944675</udiDi>
    <basicUdiDi>694831892a006MF</basicUdiDi>
    <tradeName>06948318944675</tradeName>
    <deviceName>Sclerotherapy Needle</deviceName>
    <manufacturerName>Anrei Medical (HZ) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009964</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G03020101</emdnCode>
    <emdnDescription>DIGESTIVE ENDOSCOPY, SINGLE-LUMEN NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AMHNE-2418-2104C</reference>
    <placedOnMarketCountry>Croatia</placedOnMarketCountry>
    <lastUpdated>2026-06-28T00:49:07.989Z</lastUpdated>
  </row>
</eudamedExport>