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    <tradeName>06970658700109</tradeName>
    <deviceName>Disposable Blood Component 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 IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>B030104</emdnCode>
    <emdnDescription>APHERESIS MULTIPLE BLOOD COMPONENT COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T04:30:51.654Z</lastUpdated>
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    <udiDi>06970658700079</udiDi>
    <basicUdiDi>B-06970658700079</basicUdiDi>
    <tradeName>06970658700079</tradeName>
    <deviceName>Disposable Blood Component 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 IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>B030104</emdnCode>
    <emdnDescription>APHERESIS MULTIPLE BLOOD COMPONENT COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T04:30:50.459Z</lastUpdated>
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    <udiDi>06970658700055</udiDi>
    <basicUdiDi>B-06970658700055</basicUdiDi>
    <tradeName>06970658700055</tradeName>
    <deviceName>Disposable Blood Component 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 IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>B030104</emdnCode>
    <emdnDescription>APHERESIS MULTIPLE BLOOD COMPONENT COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T04:30:44.455Z</lastUpdated>
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    <udiDi>06970658700024</udiDi>
    <basicUdiDi>B-06970658700024</basicUdiDi>
    <tradeName>06970658700024</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>2026-06-30T04:30:43.256Z</lastUpdated>
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    <udiDi>06970658700017</udiDi>
    <basicUdiDi>B-06970658700017</basicUdiDi>
    <tradeName>06970658700017</tradeName>
    <deviceName>Disposable Blood Component 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 IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>B030104</emdnCode>
    <emdnDescription>APHERESIS MULTIPLE BLOOD COMPONENT COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T04:30:42.054Z</lastUpdated>
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    <udiDi>06947462401492</udiDi>
    <basicUdiDi>6947462411111134LS</basicUdiDi>
    <tradeName>PRF Tubes</tradeName>
    <deviceName>PRF Tubes</deviceName>
    <manufacturerName>Zhejiang Gongdong Medical Technology Co., Ltd.,</manufacturerName>
    <manufacturerSrn>CN-MF-000005694</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>B030102</emdnCode>
    <emdnDescription>APHERESIS PLATELET COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GD0105A-G</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-27T22:29:26.847Z</lastUpdated>
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    <udiDi>06947462401478</udiDi>
    <basicUdiDi>6947462411111134LS</basicUdiDi>
    <tradeName>PRF Tubes</tradeName>
    <deviceName>PRF Tubes</deviceName>
    <manufacturerName>Zhejiang Gongdong Medical Technology Co., Ltd.,</manufacturerName>
    <manufacturerSrn>CN-MF-000005694</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>B030102</emdnCode>
    <emdnDescription>APHERESIS PLATELET COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GD0130A-G</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-27T22:29:25.645Z</lastUpdated>
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    <udiDi>06947462401454</udiDi>
    <basicUdiDi>6947462411111134LS</basicUdiDi>
    <tradeName>PRF Tubes</tradeName>
    <deviceName>PRF Tubes</deviceName>
    <manufacturerName>Zhejiang Gongdong Medical Technology Co., Ltd.,</manufacturerName>
    <manufacturerSrn>CN-MF-000005694</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>B030102</emdnCode>
    <emdnDescription>APHERESIS PLATELET COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G0105A-R</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-27T22:29:24.736Z</lastUpdated>
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    <udiDi>06975500540988</udiDi>
    <basicUdiDi>697550054NIBP001N2</basicUdiDi>
    <tradeName>Blood pressure cuff</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Life Discover Medical System Co., Limited</manufacturerName>
    <manufacturerSrn>CN-MF-000019422</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>B030101</emdnCode>
    <emdnDescription>APHERESIS PLASMA COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SF-001A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-27T19:48:03.097Z</lastUpdated>
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    <udiDi>06975500540995</udiDi>
    <basicUdiDi>697550054NIBP001N2</basicUdiDi>
    <tradeName>Blood pressure cuff</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Life Discover Medical System Co., Limited</manufacturerName>
    <manufacturerSrn>CN-MF-000019422</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>B030101</emdnCode>
    <emdnDescription>APHERESIS PLASMA COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SF-001B</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-27T19:48:02.832Z</lastUpdated>
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  <row>
    <udiDi>06975500541008</udiDi>
    <basicUdiDi>697550054NIBP001N2</basicUdiDi>
    <tradeName>Blood pressure cuff</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Life Discover Medical System Co., Limited</manufacturerName>
    <manufacturerSrn>CN-MF-000019422</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>B030101</emdnCode>
    <emdnDescription>APHERESIS PLASMA COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SF-001C</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-27T19:48:02.652Z</lastUpdated>
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    <udiDi>06975500541015</udiDi>
    <basicUdiDi>697550054NIBP001N2</basicUdiDi>
    <tradeName>Blood pressure cuff</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Life Discover Medical System Co., Limited</manufacturerName>
    <manufacturerSrn>CN-MF-000019422</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>B030101</emdnCode>
    <emdnDescription>APHERESIS PLASMA COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SF-003B</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-27T19:48:02.478Z</lastUpdated>
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  <row>
    <udiDi>06975500541022</udiDi>
    <basicUdiDi>697550054NIBP001N2</basicUdiDi>
    <tradeName>Blood pressure cuff</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Life Discover Medical System Co., Limited</manufacturerName>
    <manufacturerSrn>CN-MF-000019422</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>B030101</emdnCode>
    <emdnDescription>APHERESIS PLASMA COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SF-002A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-27T19:48:02.284Z</lastUpdated>
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  <row>
    <udiDi>06975500541039</udiDi>
    <basicUdiDi>697550054NIBP001N2</basicUdiDi>
    <tradeName>Blood pressure cuff</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Life Discover Medical System Co., Limited</manufacturerName>
    <manufacturerSrn>CN-MF-000019422</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>B030101</emdnCode>
    <emdnDescription>APHERESIS PLASMA COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SF-002B</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-27T19:48:01.905Z</lastUpdated>
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    <udiDi>06975500541046</udiDi>
    <basicUdiDi>697550054NIBP001N2</basicUdiDi>
    <tradeName>Blood pressure cuff</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Life Discover Medical System Co., Limited</manufacturerName>
    <manufacturerSrn>CN-MF-000019422</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>B030101</emdnCode>
    <emdnDescription>APHERESIS PLASMA COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SF-002C</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-27T19:48:01.727Z</lastUpdated>
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    <udiDi>06975500541053</udiDi>
    <basicUdiDi>697550054NIBP001N2</basicUdiDi>
    <tradeName>Blood pressure cuff</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Life Discover Medical System Co., Limited</manufacturerName>
    <manufacturerSrn>CN-MF-000019422</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>B030101</emdnCode>
    <emdnDescription>APHERESIS PLASMA COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SF-202LA</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-27T19:48:01.542Z</lastUpdated>
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    <udiDi>06975500541077</udiDi>
    <basicUdiDi>697550054NIBP001N2</basicUdiDi>
    <tradeName>Blood pressure cuff</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Life Discover Medical System Co., Limited</manufacturerName>
    <manufacturerSrn>CN-MF-000019422</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>B030101</emdnCode>
    <emdnDescription>APHERESIS PLASMA COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SF-202LL</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-27T19:48:01.407Z</lastUpdated>
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    <udiDi>05020583122208</udiDi>
    <basicUdiDi>5020583OptiaExchBF</basicUdiDi>
    <tradeName>Spectra Optia™ Exchange Set</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Terumo BCT, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000001069</manufacturerSrn>
    <authorisedRepresentativeName>Terumo BCT Europe N.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000001030</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>B030199</emdnCode>
    <emdnDescription>APHERESIS COLLECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>12220</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-27T19:32:22.345Z</lastUpdated>
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    <udiDi>05020583260115</udiDi>
    <basicUdiDi>5020583TRACIIAccessoryFP</basicUdiDi>
    <tradeName>T-RAC II Transport Case</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Terumo BCT, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000001069</manufacturerSrn>
    <authorisedRepresentativeName>Terumo BCT Europe N.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000001030</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>B030199</emdnCode>
    <emdnDescription>APHERESIS COLLECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ME-TRAC203</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-27T19:32:22.259Z</lastUpdated>
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    <udiDi>06975500540612</udiDi>
    <basicUdiDi>697550054NIBP001N2</basicUdiDi>
    <tradeName>Blood pressure cuff</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Life Discover Medical System Co., Limited</manufacturerName>
    <manufacturerSrn>CN-MF-000019422</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>B030101</emdnCode>
    <emdnDescription>APHERESIS PLASMA COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CM-1025S-06</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:16:09.967Z</lastUpdated>
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