<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06970658702462</udiDi>
    <basicUdiDi>B-06970658702462</basicUdiDi>
    <tradeName>06970658702462</tradeName>
    <deviceName>Disposable Plasma Apheresis Set</deviceName>
    <manufacturerName>Sichuan Nigale Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000015825</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>B030101</emdnCode>
    <emdnDescription>APHERESIS PLASMA COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T04:32:16.912Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970658702455</udiDi>
    <basicUdiDi>B-06970658702455</basicUdiDi>
    <tradeName>06970658702455</tradeName>
    <deviceName>Disposable Plasma Apheresis Set</deviceName>
    <manufacturerName>Sichuan Nigale Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000015825</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>B030101</emdnCode>
    <emdnDescription>APHERESIS PLASMA COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T04:32:10.908Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970658702424</udiDi>
    <basicUdiDi>B-06970658702424</basicUdiDi>
    <tradeName>06970658702424</tradeName>
    <deviceName>Disposable Plasma Apheresis Set</deviceName>
    <manufacturerName>Sichuan Nigale Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000015825</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>B030101</emdnCode>
    <emdnDescription>APHERESIS PLASMA COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T04:32:09.705Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970658702417</udiDi>
    <basicUdiDi>B-06970658702417</basicUdiDi>
    <tradeName>06970658702417</tradeName>
    <deviceName>Disposable Plasma Apheresis Set</deviceName>
    <manufacturerName>Sichuan Nigale Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000015825</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>B030101</emdnCode>
    <emdnDescription>APHERESIS PLASMA COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T04:32:08.521Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970658702400</udiDi>
    <basicUdiDi>B-06970658702400</basicUdiDi>
    <tradeName>06970658702400</tradeName>
    <deviceName>Disposable Plasma Apheresis Set</deviceName>
    <manufacturerName>Sichuan Nigale Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000015825</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>B030101</emdnCode>
    <emdnDescription>APHERESIS PLASMA COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T04:32:07.328Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970658702394</udiDi>
    <basicUdiDi>B-06970658702394</basicUdiDi>
    <tradeName>06970658702394</tradeName>
    <deviceName>Disposable Plasma Apheresis Set</deviceName>
    <manufacturerName>Sichuan Nigale Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000015825</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>B030101</emdnCode>
    <emdnDescription>APHERESIS PLASMA COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T04:32:01.320Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970658702387</udiDi>
    <basicUdiDi>B-06970658702387</basicUdiDi>
    <tradeName>06970658702387</tradeName>
    <deviceName>Disposable Plasma Apheresis Set</deviceName>
    <manufacturerName>Sichuan Nigale Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000015825</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>B030101</emdnCode>
    <emdnDescription>APHERESIS PLASMA COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T04:32:00.101Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970658702370</udiDi>
    <basicUdiDi>B-06970658702370</basicUdiDi>
    <tradeName>06970658702370</tradeName>
    <deviceName>Disposable Plasma Apheresis Set</deviceName>
    <manufacturerName>Sichuan Nigale Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000015825</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>B030101</emdnCode>
    <emdnDescription>APHERESIS PLASMA COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T04:31:58.915Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970658702363</udiDi>
    <basicUdiDi>B-06970658702363</basicUdiDi>
    <tradeName>06970658702363</tradeName>
    <deviceName>Disposable Plasma Apheresis Set</deviceName>
    <manufacturerName>Sichuan Nigale Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000015825</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>B030101</emdnCode>
    <emdnDescription>APHERESIS PLASMA COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T04:31:57.716Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970658702349</udiDi>
    <basicUdiDi>B-06970658702349</basicUdiDi>
    <tradeName>06970658702349</tradeName>
    <deviceName>Disposable Plasma Apheresis Set</deviceName>
    <manufacturerName>Sichuan Nigale Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000015825</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>B030101</emdnCode>
    <emdnDescription>APHERESIS PLASMA COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T04:31:51.708Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970658702332</udiDi>
    <basicUdiDi>B-06970658702332</basicUdiDi>
    <tradeName>06970658702332</tradeName>
    <deviceName>Disposable Plasma Apheresis Set</deviceName>
    <manufacturerName>Sichuan Nigale Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000015825</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>B030101</emdnCode>
    <emdnDescription>APHERESIS PLASMA COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T04:31:50.488Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970658702325</udiDi>
    <basicUdiDi>B-06970658702325</basicUdiDi>
    <tradeName>06970658702325</tradeName>
    <deviceName>Disposable Plasma Apheresis Set</deviceName>
    <manufacturerName>Sichuan Nigale Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000015825</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>B030101</emdnCode>
    <emdnDescription>APHERESIS PLASMA COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T04:31:49.290Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970658702318</udiDi>
    <basicUdiDi>B-06970658702318</basicUdiDi>
    <tradeName>06970658702318</tradeName>
    <deviceName>Disposable Plasma Apheresis Set</deviceName>
    <manufacturerName>Sichuan Nigale Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000015825</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>B030101</emdnCode>
    <emdnDescription>APHERESIS PLASMA COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T04:31:48.097Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970658701687</udiDi>
    <basicUdiDi>B-06970658701687</basicUdiDi>
    <tradeName>06970658701687</tradeName>
    <deviceName>Disposable Plasma Apheresis Set</deviceName>
    <manufacturerName>Sichuan Nigale Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000015825</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>B030101</emdnCode>
    <emdnDescription>APHERESIS PLASMA COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T04:31:42.084Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970658701670</udiDi>
    <basicUdiDi>B-06970658701670</basicUdiDi>
    <tradeName>06970658701670</tradeName>
    <deviceName>Disposable Plasma Apheresis Set</deviceName>
    <manufacturerName>Sichuan Nigale Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000015825</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>B030101</emdnCode>
    <emdnDescription>APHERESIS PLASMA COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T04:31:40.887Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970658701113</udiDi>
    <basicUdiDi>B-06970658701113</basicUdiDi>
    <tradeName>06970658701113</tradeName>
    <deviceName>Plasma Separator</deviceName>
    <manufacturerName>Sichuan Nigale Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000015825</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>B030101</emdnCode>
    <emdnDescription>APHERESIS PLASMA COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T04:31:38.495Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970658701106</udiDi>
    <basicUdiDi>B-06970658701106</basicUdiDi>
    <tradeName>06970658701106</tradeName>
    <deviceName>Plasma Separator</deviceName>
    <manufacturerName>Sichuan Nigale Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000015825</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>B030101</emdnCode>
    <emdnDescription>APHERESIS PLASMA COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T04:31:32.507Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970658700772</udiDi>
    <basicUdiDi>B-06970658700772</basicUdiDi>
    <tradeName>06970658700772</tradeName>
    <deviceName>Disposable Plasma Apheresis Set</deviceName>
    <manufacturerName>Sichuan Nigale Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000015825</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>B030101</emdnCode>
    <emdnDescription>APHERESIS PLASMA COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T04:31:31.286Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970658700765</udiDi>
    <basicUdiDi>B-06970658700765</basicUdiDi>
    <tradeName>06970658700765</tradeName>
    <deviceName>Disposable Plasma Apheresis Set</deviceName>
    <manufacturerName>Sichuan Nigale Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000015825</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>B030101</emdnCode>
    <emdnDescription>APHERESIS PLASMA COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T04:31:30.077Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970658700758</udiDi>
    <basicUdiDi>B-06970658700758</basicUdiDi>
    <tradeName>06970658700758</tradeName>
    <deviceName>Disposable Plasma Apheresis Set</deviceName>
    <manufacturerName>Sichuan Nigale Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000015825</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>B030101</emdnCode>
    <emdnDescription>APHERESIS PLASMA COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T04:31:28.873Z</lastUpdated>
  </row>
</eudamedExport>