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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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    <basicUdiDi>B-00816394021411</basicUdiDi>
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    <deviceName>Refrigerator</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>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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    <udiDi>00816394021404</udiDi>
    <basicUdiDi>B-00816394021404</basicUdiDi>
    <tradeName>i.Series</tradeName>
    <deviceName>Refrigerator</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>
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    <emdnDescription>BLOOD BANKS REFRIGERATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>iBR226-GX</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:35:26.579Z</lastUpdated>
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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>
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    <emdnDescription>VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HPR256-GX</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:35:24.969Z</lastUpdated>
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    <udiDi>00816394021381</udiDi>
    <basicUdiDi>B-00816394021381</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>iPR256-GX</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:35:22.571Z</lastUpdated>
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    <udiDi>00816394021374</udiDi>
    <basicUdiDi>B-00816394021374</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>HLR256-GX</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:35:20.967Z</lastUpdated>
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    <udiDi>00816394021367</udiDi>
    <basicUdiDi>B-00816394021367</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>iLR256-GX</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:35:20.172Z</lastUpdated>
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    <udiDi>00816394021350</udiDi>
    <basicUdiDi>B-00816394021350</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>HBR256-GX</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:35:18.566Z</lastUpdated>
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    <udiDi>00816394021343</udiDi>
    <basicUdiDi>B-00816394021343</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>Z121701</emdnCode>
    <emdnDescription>BLOOD BANKS REFRIGERATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>iBR256-GX</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:35:16.166Z</lastUpdated>
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    <udiDi>00816394021336</udiDi>
    <basicUdiDi>B-00816394021336</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>HPR245-GX</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:35:14.561Z</lastUpdated>
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    <udiDi>00816394021329</udiDi>
    <basicUdiDi>B-00816394021329</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>iPR245-GX</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:35:13.780Z</lastUpdated>
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    <udiDi>00816394021312</udiDi>
    <basicUdiDi>B-00816394021312</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>HLR245-GX</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:35:12.163Z</lastUpdated>
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    <udiDi>00816394021282</udiDi>
    <basicUdiDi>B-00816394021282</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>Z121701</emdnCode>
    <emdnDescription>BLOOD BANKS REFRIGERATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>iBR245-GX</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:35:09.775Z</lastUpdated>
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    <udiDi>00816394021305</udiDi>
    <basicUdiDi>B-00816394021305</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>iLR245-GX</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:35:08.156Z</lastUpdated>
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    <udiDi>00816394021299</udiDi>
    <basicUdiDi>B-00816394021299</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>HBR245-GX</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:35:07.461Z</lastUpdated>
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    <udiDi>00816394021275</udiDi>
    <basicUdiDi>B-00816394021275</basicUdiDi>
    <tradeName>Horizon Series</tradeName>
    <deviceName>Refrigerator</deviceName>
    <manufacturerName>Helmer Scientific</manufacturerName>
    <manufacturerSrn>US-MF-000003326</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <emdnDescription>VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HPR125-GX</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:34:51.280Z</lastUpdated>
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    <tradeName>i.Series</tradeName>
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    <manufacturerName>Helmer Scientific</manufacturerName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>iPR125-GX</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:34:50.480Z</lastUpdated>
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    <udiDi>00816394021251</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>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>HLR125-GX</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:34:49.682Z</lastUpdated>
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    <tradeName>i.Series</tradeName>
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    <manufacturerName>Helmer Scientific</manufacturerName>
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    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>iLR125-GX</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:34:48.896Z</lastUpdated>
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    <tradeName>Horizon Series</tradeName>
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    <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>Z121701</emdnCode>
    <emdnDescription>BLOOD BANKS REFRIGERATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HBR125-GX</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:34:44.876Z</lastUpdated>
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