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    <tradeName>Meling Biomedical</tradeName>
    <deviceName>Ultra-Low Temperature Freezer</deviceName>
    <manufacturerName>Zhongke Meiling Cryogenics Company Limited.</manufacturerName>
    <manufacturerSrn>CN-MF-000034599</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
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    <legislation>MDD</legislation>
    <emdnCode>Z121702</emdnCode>
    <emdnDescription>BLOOD AND BLOOD COMPONENTS FREEZERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ML9039923</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T11:47:55.747Z</lastUpdated>
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    <udiDi>06972244264125</udiDi>
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    <tradeName>Meling Biomedical</tradeName>
    <deviceName>Ultra-Low Temperature Freezer</deviceName>
    <manufacturerName>Zhongke Meiling Cryogenics Company Limited.</manufacturerName>
    <manufacturerSrn>CN-MF-000034599</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z121702</emdnCode>
    <emdnDescription>BLOOD AND BLOOD COMPONENTS FREEZERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ML9039926</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T11:47:53.202Z</lastUpdated>
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    <udiDi>06972244261070</udiDi>
    <basicUdiDi>B-06972244261070</basicUdiDi>
    <tradeName>Meling Biomedical</tradeName>
    <deviceName>Ultra-Low Temperature Freezer</deviceName>
    <manufacturerName>Zhongke Meiling Cryogenics Company Limited.</manufacturerName>
    <manufacturerSrn>CN-MF-000034599</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
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    <legislation>MDD</legislation>
    <emdnCode>Z121702</emdnCode>
    <emdnDescription>BLOOD AND BLOOD COMPONENTS FREEZERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ML9039927</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T11:47:49.213Z</lastUpdated>
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    <udiDi>06971745390012</udiDi>
    <basicUdiDi>B-06971745390012</basicUdiDi>
    <tradeName>06971745390012</tradeName>
    <deviceName>Plasma Collection Machine</deviceName>
    <manufacturerName>Scinomed (Shanghai) Bio-tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032643</manufacturerSrn>
    <authorisedRepresentativeName>Scinomed Deutschland GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000016022</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12170401</emdnCode>
    <emdnDescription>BLOOD DONATION APHERESIS EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:46:30.115Z</lastUpdated>
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    <udiDi>08588009681014</udiDi>
    <basicUdiDi>8588009681ACFSDC</basicUdiDi>
    <tradeName>AC Medical Freezer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Auguste Cryogenics Slovakia s.r.o.</manufacturerName>
    <manufacturerSrn>SK-MF-000026173</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z121702</emdnCode>
    <emdnDescription>BLOOD AND BLOOD COMPONENTS FREEZERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AC IVF 430</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T08:17:55.648Z</lastUpdated>
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    <udiDi>08588009681021</udiDi>
    <basicUdiDi>8588009681ACFSDC</basicUdiDi>
    <tradeName>AC Medical Freezer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Auguste Cryogenics Slovakia s.r.o.</manufacturerName>
    <manufacturerSrn>SK-MF-000026173</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z121702</emdnCode>
    <emdnDescription>BLOOD AND BLOOD COMPONENTS FREEZERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AC BIO 860</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T08:17:55.633Z</lastUpdated>
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    <udiDi>08588009681038</udiDi>
    <basicUdiDi>8588009681ACFSDC</basicUdiDi>
    <tradeName>AC Medical Freezer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Auguste Cryogenics Slovakia s.r.o.</manufacturerName>
    <manufacturerSrn>SK-MF-000026173</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z121702</emdnCode>
    <emdnDescription>BLOOD AND BLOOD COMPONENTS FREEZERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AC SYS 480</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T08:17:55.614Z</lastUpdated>
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    <basicUdiDi>8588009681ACFSDC</basicUdiDi>
    <tradeName>AC Medical Freezer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Auguste Cryogenics Slovakia s.r.o.</manufacturerName>
    <manufacturerSrn>SK-MF-000026173</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z121702</emdnCode>
    <emdnDescription>BLOOD AND BLOOD COMPONENTS FREEZERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AC BIO 430X</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T08:17:55.592Z</lastUpdated>
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    <udiDi>00816394021671</udiDi>
    <basicUdiDi>B-00816394021671</basicUdiDi>
    <tradeName>i.Series</tradeName>
    <deviceName>Platelet Incubator</deviceName>
    <manufacturerName>Helmer Scientific</manufacturerName>
    <manufacturerSrn>US-MF-000003326</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z121799</emdnCode>
    <emdnDescription>BLOOD TRANSFUSION INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PC3200-PRO</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:36:13.878Z</lastUpdated>
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    <udiDi>00816394021664</udiDi>
    <basicUdiDi>B-00816394021664</basicUdiDi>
    <tradeName>i.Series</tradeName>
    <deviceName>Platelet Incubator</deviceName>
    <manufacturerName>Helmer Scientific</manufacturerName>
    <manufacturerSrn>US-MF-000003326</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z121799</emdnCode>
    <emdnDescription>BLOOD TRANSFUSION INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PC4200-PRO</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:36:13.064Z</lastUpdated>
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    <udiDi>00816394021688</udiDi>
    <basicUdiDi>B-00816394021688</basicUdiDi>
    <tradeName>i.Series</tradeName>
    <deviceName>Platelet Incubator</deviceName>
    <manufacturerName>Helmer Scientific</manufacturerName>
    <manufacturerSrn>US-MF-000003326</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z121799</emdnCode>
    <emdnDescription>BLOOD TRANSFUSION INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PC2200-PRO</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:36:12.280Z</lastUpdated>
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    <udiDi>00816394021602</udiDi>
    <basicUdiDi>B-00816394021602</basicUdiDi>
    <tradeName>Horizon Series</tradeName>
    <deviceName>Freezer</deviceName>
    <manufacturerName>Helmer Scientific</manufacturerName>
    <manufacturerSrn>US-MF-000003326</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z121702</emdnCode>
    <emdnDescription>BLOOD AND BLOOD COMPONENTS FREEZERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HBF125-GX</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:36:08.363Z</lastUpdated>
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    <udiDi>00816394021596</udiDi>
    <basicUdiDi>B-00816394021596</basicUdiDi>
    <tradeName>i.Series</tradeName>
    <deviceName>Freezer</deviceName>
    <manufacturerName>Helmer Scientific</manufacturerName>
    <manufacturerSrn>US-MF-000003326</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z121702</emdnCode>
    <emdnDescription>BLOOD AND BLOOD COMPONENTS FREEZERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>iBF125-GX</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:35:54.597Z</lastUpdated>
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    <udiDi>00816394021589</udiDi>
    <basicUdiDi>B-00816394021589</basicUdiDi>
    <tradeName>Horizon Series</tradeName>
    <deviceName>Freezer</deviceName>
    <manufacturerName>Helmer Scientific</manufacturerName>
    <manufacturerSrn>US-MF-000003326</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z121702</emdnCode>
    <emdnDescription>BLOOD AND BLOOD COMPONENTS FREEZERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HBF120-GX</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:35:53.015Z</lastUpdated>
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    <udiDi>00816394021572</udiDi>
    <basicUdiDi>B-00816394021572</basicUdiDi>
    <tradeName>i.Series</tradeName>
    <deviceName>Freezer</deviceName>
    <manufacturerName>Helmer Scientific</manufacturerName>
    <manufacturerSrn>US-MF-000003326</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z121702</emdnCode>
    <emdnDescription>BLOOD AND BLOOD COMPONENTS FREEZERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>iBF120-GX</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:35:52.189Z</lastUpdated>
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    <udiDi>00816394021565</udiDi>
    <basicUdiDi>B-00816394021565</basicUdiDi>
    <tradeName>Horizon Series</tradeName>
    <deviceName>Freezer</deviceName>
    <manufacturerName>Helmer Scientific</manufacturerName>
    <manufacturerSrn>US-MF-000003326</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z121702</emdnCode>
    <emdnDescription>BLOOD AND BLOOD COMPONENTS FREEZERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HBF105-GX</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:35:50.593Z</lastUpdated>
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    <udiDi>00816394021558</udiDi>
    <basicUdiDi>B-00816394021558</basicUdiDi>
    <tradeName>i.Series</tradeName>
    <deviceName>Freezer</deviceName>
    <manufacturerName>Helmer Scientific</manufacturerName>
    <manufacturerSrn>US-MF-000003326</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z121702</emdnCode>
    <emdnDescription>BLOOD AND BLOOD COMPONENTS FREEZERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>iBF105-GX</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:35:48.189Z</lastUpdated>
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    <udiDi>00816394021435</udiDi>
    <basicUdiDi>B-00816394021435</basicUdiDi>
    <tradeName>Horizon Series</tradeName>
    <deviceName>Refrigerator</deviceName>
    <manufacturerName>Helmer Scientific</manufacturerName>
    <manufacturerSrn>US-MF-000003326</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z121701</emdnCode>
    <emdnDescription>BLOOD BANKS REFRIGERATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HBR458-GX</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:35:31.383Z</lastUpdated>
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    <udiDi>00816394021428</udiDi>
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    <tradeName>i.Series</tradeName>
    <deviceName>Refrigerator</deviceName>
    <manufacturerName>Helmer Scientific</manufacturerName>
    <manufacturerSrn>US-MF-000003326</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z121701</emdnCode>
    <emdnDescription>BLOOD BANKS REFRIGERATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>iBR458-GX</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:35:28.972Z</lastUpdated>
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    <udiDi>00816394021411</udiDi>
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    <tradeName>Horizon Series</tradeName>
    <deviceName>Refrigerator</deviceName>
    <manufacturerName>Helmer Scientific</manufacturerName>
    <manufacturerSrn>US-MF-000003326</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z121701</emdnCode>
    <emdnDescription>BLOOD BANKS REFRIGERATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HBR226-GX</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:35:27.375Z</lastUpdated>
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