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    <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>
    <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>iBF105-GX</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:35:48.189Z</lastUpdated>
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    <udiDi>00816394021541</udiDi>
    <basicUdiDi>B-00816394021541</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>V9099</emdnCode>
    <emdnDescription>VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HLF125-GX</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:35:46.600Z</lastUpdated>
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    <udiDi>00816394021534</udiDi>
    <basicUdiDi>B-00816394021534</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>V9099</emdnCode>
    <emdnDescription>VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>iLF125-GX</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:35:45.786Z</lastUpdated>
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    <udiDi>00816394021527</udiDi>
    <basicUdiDi>B-00816394021527</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>V9099</emdnCode>
    <emdnDescription>VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HLF120-GX</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:35:44.187Z</lastUpdated>
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    <udiDi>00816394021510</udiDi>
    <basicUdiDi>B-00816394021510</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>V9099</emdnCode>
    <emdnDescription>VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>iLF120-GX</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:35:41.783Z</lastUpdated>
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    <udiDi>00816394021503</udiDi>
    <basicUdiDi>B-00816394021503</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>V9099</emdnCode>
    <emdnDescription>VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HLF105-GX</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:35:40.182Z</lastUpdated>
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    <udiDi>00816394021497</udiDi>
    <basicUdiDi>B-00816394021497</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>V9099</emdnCode>
    <emdnDescription>VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>iLF105-GX</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:35:39.394Z</lastUpdated>
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    <udiDi>00816394021480</udiDi>
    <basicUdiDi>B-00816394021480</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>V9099</emdnCode>
    <emdnDescription>VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HPR458-GX</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:35:37.780Z</lastUpdated>
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    <udiDi>00816394021466</udiDi>
    <basicUdiDi>B-00816394021466</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>V9099</emdnCode>
    <emdnDescription>VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HPR226-GX</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:35:35.378Z</lastUpdated>
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    <udiDi>00816394021459</udiDi>
    <basicUdiDi>B-00816394021459</basicUdiDi>
    <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>V9099</emdnCode>
    <emdnDescription>VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>iPR226-GX</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:35:33.777Z</lastUpdated>
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    <udiDi>00816394021442</udiDi>
    <basicUdiDi>B-00816394021442</basicUdiDi>
    <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>V9099</emdnCode>
    <emdnDescription>VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>iPR458-GX</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:35:32.975Z</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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