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    <tradeName>10704411020097</tradeName>
    <deviceName>Blood Transfusion Set with needle</deviceName>
    <manufacturerName>Amsino International Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007234</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>TF-4D2</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T00:04:18.949Z</lastUpdated>
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    <tradeName>10704411020080</tradeName>
    <deviceName>Blood Transfusion Set with needle</deviceName>
    <manufacturerName>Amsino International Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007234</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-07-11T00:04:18.160Z</lastUpdated>
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    <tradeName>10704411020073</tradeName>
    <deviceName>Blood Transfusion Set with needle</deviceName>
    <manufacturerName>Amsino International Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007234</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T00:04:14.157Z</lastUpdated>
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    <udiDi>10704411019992</udiDi>
    <basicUdiDi>B-10704411019992</basicUdiDi>
    <tradeName>AMSafe® Blood transfusion set with needle</tradeName>
    <deviceName>Blood Transfusion Set with needle</deviceName>
    <manufacturerName>Amsino International Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007234</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>B99</emdnCode>
    <emdnDescription>HAEMATOLOGY AND HAEMOTRANSFUSION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AS2101</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T00:04:13.348Z</lastUpdated>
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    <udiDi>10704411019985</udiDi>
    <basicUdiDi>B-10704411019985</basicUdiDi>
    <tradeName>AMSINO Blood Administration Set</tradeName>
    <deviceName>Blood Transfusion Set</deviceName>
    <manufacturerName>Amsino International Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007234</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>B99</emdnCode>
    <emdnDescription>HAEMATOLOGY AND HAEMOTRANSFUSION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AS2100SI</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T00:04:12.540Z</lastUpdated>
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    <udiDi>10704411018919</udiDi>
    <basicUdiDi>B-10704411018919</basicUdiDi>
    <tradeName>AMSINO Adult Non-Vented Blood Set</tradeName>
    <deviceName>Blood Transfusion Set</deviceName>
    <manufacturerName>Amsino International Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007234</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>B99</emdnCode>
    <emdnDescription>HAEMATOLOGY AND HAEMOTRANSFUSION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AS2112R</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T00:03:59.748Z</lastUpdated>
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    <udiDi>10704411018902</udiDi>
    <basicUdiDi>B-10704411018902</basicUdiDi>
    <tradeName>AMSINO Non-Vented Blood Set</tradeName>
    <deviceName>Blood Transfusion Set with needle</deviceName>
    <manufacturerName>Amsino International Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007234</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>B99</emdnCode>
    <emdnDescription>HAEMATOLOGY AND HAEMOTRANSFUSION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AS2113R</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T00:03:58.934Z</lastUpdated>
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    <udiDi>10704411018896</udiDi>
    <basicUdiDi>B-10704411018896</basicUdiDi>
    <tradeName>AMSINO Adult Non-Vented Blood Set</tradeName>
    <deviceName>Blood Transfusion Set</deviceName>
    <manufacturerName>Amsino International Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007234</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>B99</emdnCode>
    <emdnDescription>HAEMATOLOGY AND HAEMOTRANSFUSION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AS2109SRN</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T00:03:54.941Z</lastUpdated>
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    <udiDi>10704411018889</udiDi>
    <basicUdiDi>B-10704411018889</basicUdiDi>
    <tradeName>AMSINO Adult Non-Vented Blood Set</tradeName>
    <deviceName>Blood Transfusion Set</deviceName>
    <manufacturerName>Amsino International Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007234</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>B99</emdnCode>
    <emdnDescription>HAEMATOLOGY AND HAEMOTRANSFUSION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AS2110R</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T00:03:54.130Z</lastUpdated>
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    <udiDi>10704411018872</udiDi>
    <basicUdiDi>B-10704411018872</basicUdiDi>
    <tradeName>AMSINO Blood Administration Set</tradeName>
    <deviceName>Blood Transfusion Set</deviceName>
    <manufacturerName>Amsino International Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007234</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>B99</emdnCode>
    <emdnDescription>HAEMATOLOGY AND HAEMOTRANSFUSION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AS2108L</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T00:03:53.325Z</lastUpdated>
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    <udiDi>10704411018865</udiDi>
    <basicUdiDi>B-10704411018865</basicUdiDi>
    <tradeName>AMSINO Blood Administration Set</tradeName>
    <deviceName>Blood Transfusion Set</deviceName>
    <manufacturerName>Amsino International Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007234</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>B99</emdnCode>
    <emdnDescription>HAEMATOLOGY AND HAEMOTRANSFUSION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AS2106L</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T00:03:52.545Z</lastUpdated>
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    <udiDi>10704411016373</udiDi>
    <basicUdiDi>B-10704411016373</basicUdiDi>
    <tradeName>AMSafe® Needleless Blood or Solution Admin Set</tradeName>
    <deviceName>Blood Transfusion Set</deviceName>
    <manufacturerName>Amsino International Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007234</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>B99</emdnCode>
    <emdnDescription>HAEMATOLOGY AND HAEMOTRANSFUSION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AS2114</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T00:01:14.693Z</lastUpdated>
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    <udiDi>10704411011194</udiDi>
    <basicUdiDi>B-10704411011194</basicUdiDi>
    <tradeName>AMSINO Y-Type Blood Set</tradeName>
    <deviceName>Blood Transfusion Set</deviceName>
    <manufacturerName>Amsino International Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007234</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>B99</emdnCode>
    <emdnDescription>HAEMATOLOGY AND HAEMOTRANSFUSION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AS2108SI</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T23:56:31.697Z</lastUpdated>
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    <udiDi>10704411010616</udiDi>
    <basicUdiDi>B-10704411010616</basicUdiDi>
    <tradeName>AMSINO Y-Type Blood Set</tradeName>
    <deviceName>Blood Transfusion Set</deviceName>
    <manufacturerName>Amsino International Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007234</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>B99</emdnCode>
    <emdnDescription>HAEMATOLOGY AND HAEMOTRANSFUSION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AS2108DV</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T23:56:25.288Z</lastUpdated>
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    <basicUdiDi>84353898PRGFENDORET-KITL4</basicUdiDi>
    <tradeName>08435389830719</tradeName>
    <deviceName></deviceName>
    <manufacturerName>B.T.I. BIOTECHNOLOGY INSTITUTE, S.L</manufacturerName>
    <manufacturerSrn>ES-PR-000001719</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>B019001</emdnCode>
    <emdnDescription>PLATELET GEL AND FIBRIN GLUE PRODUCTION BAGS AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KMU10</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-10T19:49:17.391Z</lastUpdated>
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    <deviceName></deviceName>
    <manufacturerName>B.T.I. BIOTECHNOLOGY INSTITUTE, S.L</manufacturerName>
    <manufacturerSrn>ES-PR-000001719</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnCode>B019001</emdnCode>
    <emdnDescription>PLATELET GEL AND FIBRIN GLUE PRODUCTION BAGS AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-07-10T19:49:16.433Z</lastUpdated>
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    <tradeName>Tricell PRP</tradeName>
    <deviceName>Blood Separation Kit</deviceName>
    <manufacturerName>REV-MED Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000026506</manufacturerSrn>
    <authorisedRepresentativeName>Javitech Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000045915</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>B030101</emdnCode>
    <emdnDescription>APHERESIS PLASMA COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Tricell PRP Kit</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:43:50.101Z</lastUpdated>
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    <tradeName>TriCell PRP</tradeName>
    <deviceName>Blood Separation Kit</deviceName>
    <manufacturerName>REV-MED Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000026506</manufacturerSrn>
    <authorisedRepresentativeName>Javitech Consulting GmbH</authorisedRepresentativeName>
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    <emdnDescription>APHERESIS PLASMA COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TriCell PRP New S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:43:48.268Z</lastUpdated>
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    <tradeName>TriCell PRP</tradeName>
    <deviceName>Blood Separation Kit</deviceName>
    <manufacturerName>REV-MED Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000026506</manufacturerSrn>
    <authorisedRepresentativeName>Javitech Consulting GmbH</authorisedRepresentativeName>
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    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
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    <emdnDescription>APHERESIS PLASMA COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TriCell PRP New</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:43:43.471Z</lastUpdated>
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    <udiDi>08809326581123</udiDi>
    <basicUdiDi>B-08809326581123</basicUdiDi>
    <tradeName>Tricell PRP</tradeName>
    <deviceName>Blood Separation Kit</deviceName>
    <manufacturerName>REV-MED Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000026506</manufacturerSrn>
    <authorisedRepresentativeName>Javitech Consulting GmbH</authorisedRepresentativeName>
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    <emdnCode>B030101</emdnCode>
    <emdnDescription>APHERESIS PLASMA COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Tricell PRP L</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:43:42.679Z</lastUpdated>
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