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    <basicUdiDi>B-00816394021220</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>iBR125-GX</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:34:44.072Z</lastUpdated>
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    <udiDi>00816394021213</udiDi>
    <basicUdiDi>B-00816394021213</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>HPR120-GX</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:34:43.272Z</lastUpdated>
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    <udiDi>00816394021206</udiDi>
    <basicUdiDi>B-00816394021206</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>iPR120-GX</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:34:42.476Z</lastUpdated>
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    <udiDi>00816394021190</udiDi>
    <basicUdiDi>B-00816394021190</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>HLR120-GX</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:34:38.489Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816394021183</udiDi>
    <basicUdiDi>B-00816394021183</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>iLR120-GX</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:34:37.670Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816394021176</udiDi>
    <basicUdiDi>B-00816394021176</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>HBR120-GX</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:34:36.876Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816394021169</udiDi>
    <basicUdiDi>B-00816394021169</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>iBR120-GX</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:34:36.074Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816394021152</udiDi>
    <basicUdiDi>B-00816394021152</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>HPR113-GX</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:34:32.068Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816394021145</udiDi>
    <basicUdiDi>B-00816394021145</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>iPR113-GX</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:34:31.265Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816394021138</udiDi>
    <basicUdiDi>B-00816394021138</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>HLR113-GX</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:34:30.467Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816394021121</udiDi>
    <basicUdiDi>B-00816394021121</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>iLR113-GX</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:34:29.661Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816394021114</udiDi>
    <basicUdiDi>B-00816394021114</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>HBR113-GX</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:34:25.672Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816394021107</udiDi>
    <basicUdiDi>B-00816394021107</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>iBR113-GX</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:34:24.858Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816394021091</udiDi>
    <basicUdiDi>B-00816394021091</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>HPR105-GX</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:34:24.076Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816394021084</udiDi>
    <basicUdiDi>B-00816394021084</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>iPR105-GX</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:34:23.263Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816394021077</udiDi>
    <basicUdiDi>B-00816394021077</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>HLR105-GX</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:34:19.255Z</lastUpdated>
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    <udiDi>00816394021060</udiDi>
    <basicUdiDi>B-00816394021060</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>iLR105-GX</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:34:18.468Z</lastUpdated>
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    <udiDi>00816394021053</udiDi>
    <basicUdiDi>B-00816394021053</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>HBR105-GX</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:34:17.671Z</lastUpdated>
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  <row>
    <udiDi>00816394021046</udiDi>
    <basicUdiDi>B-00816394021046</basicUdiDi>
    <tradeName>i.Series</tradeName>
    <deviceName>iBR105-GX</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>Ibr105-gx</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:34:16.858Z</lastUpdated>
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    <udiDi>00816394020964</udiDi>
    <basicUdiDi>B-00816394020964</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>PC1200-PRO</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:34:12.852Z</lastUpdated>
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