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    <manufacturerSrn>US-MF-000003961</manufacturerSrn>
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    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
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    <legislation>UNKNOWN</legislation>
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    <lastUpdated>2026-07-26T14:41:38.166Z</lastUpdated>
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    <udiDi>00817770022107</udiDi>
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    <manufacturerName>Maxtec, LLC</manufacturerName>
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    <manufacturerName>Maxtec, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000003961</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <legislation>UNKNOWN</legislation>
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    <emdnDescription>PHOTOTHERAPY MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R300P02-008</reference>
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    <udiDi>00817770022138</udiDi>
    <basicUdiDi>081777002EyeMax2CU</basicUdiDi>
    <tradeName>EyeMax 2, Mediprema Micro 20/Pack</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Maxtec, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000003961</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
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    <emdnDescription>PHOTOTHERAPY MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R300P03-002</reference>
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    <udiDi>00817770022145</udiDi>
    <basicUdiDi>081777002EyeMax2CU</basicUdiDi>
    <tradeName>EyeMax 2, Micro USA 20/Pack</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Maxtec, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000003961</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
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    <legislation>UNKNOWN</legislation>
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    <emdnDescription>PHOTOTHERAPY MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <udiDi>00817770022152</udiDi>
    <basicUdiDi>081777002EyeMax2CU</basicUdiDi>
    <tradeName>EyeMax 2, Drager Micro MP03770 20/Pack</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Maxtec, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000003961</manufacturerSrn>
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    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
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    <legislation>UNKNOWN</legislation>
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    <emdnDescription>PHOTOTHERAPY MASKS</emdnDescription>
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    <udiDi>00817770022169</udiDi>
    <basicUdiDi>081777002EyeMax2CU</basicUdiDi>
    <tradeName>EyeMax 2, Ecuador Micro 20/Pack</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Maxtec, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000003961</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
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    <legislation>UNKNOWN</legislation>
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    <emdnDescription>PHOTOTHERAPY MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R300P03-008</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
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    <udiDi>00817770022411</udiDi>
    <basicUdiDi>081777002EyeMax2CU</basicUdiDi>
    <tradeName>EYEMAX 2, F&amp;P MICRO 20/PACK</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Maxtec, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000003961</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>V0201</emdnCode>
    <emdnDescription>PHOTOTHERAPY MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R300P03-001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-26T14:41:37.798Z</lastUpdated>
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    <udiDi>00817770025818</udiDi>
    <basicUdiDi>081777002EyeMax2CU</basicUdiDi>
    <tradeName>EyeMax 2 Micro 20/pack Italian</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Maxtec, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000003961</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>V0201</emdnCode>
    <emdnDescription>PHOTOTHERAPY MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R300P03-004</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-26T14:41:37.706Z</lastUpdated>
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    <udiDi>00817770025825</udiDi>
    <basicUdiDi>081777002EyeMax2CU</basicUdiDi>
    <tradeName>EyeMax 2 Preemie 20/pack Italian</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Maxtec, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000003961</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
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    <emdnDescription>PHOTOTHERAPY MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry></placedOnMarketCountry>
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    <udiDi>00817770025832</udiDi>
    <basicUdiDi>081777002EyeMax2CU</basicUdiDi>
    <tradeName>EyeMax 2 Regular 20/pack Italian</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Maxtec, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000003961</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>V0201</emdnCode>
    <emdnDescription>PHOTOTHERAPY MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R300P01-004</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
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    <udiDi>00853061006920</udiDi>
    <basicUdiDi>0853061006EyeMax22V</basicUdiDi>
    <tradeName>EyeMax 2 Regular</tradeName>
    <deviceName>EyeMax 2</deviceName>
    <manufacturerName>Maxtec, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000003961</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V0201</emdnCode>
    <emdnDescription>PHOTOTHERAPY MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R300P01</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:38:50.147Z</lastUpdated>
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    <udiDi>00850018561105</udiDi>
    <basicUdiDi>0850018561JAUNDICEMR</basicUdiDi>
    <tradeName>WeeSpecs, Small (28-34 cm), 50/pk</tradeName>
    <deviceName>Jaundice Management</deviceName>
    <manufacturerName>International Biomedical</manufacturerName>
    <manufacturerSrn>US-MF-000017330</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V0201</emdnCode>
    <emdnDescription>PHOTOTHERAPY MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>989805607641</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:18:46.160Z</lastUpdated>
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    <udiDi>10812594010214</udiDi>
    <basicUdiDi>081259401N72000M5</basicUdiDi>
    <tradeName>NeoShades® with Tabs Phototherapy Eye Shields - Small</tradeName>
    <deviceName>NeoShades®</deviceName>
    <manufacturerName>Neotech Products LLC</manufacturerName>
    <manufacturerSrn>US-MF-000001895</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <emdnCode>V0201</emdnCode>
    <emdnDescription>PHOTOTHERAPY MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N721</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:13:49.723Z</lastUpdated>
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    <udiDi>10812594010221</udiDi>
    <basicUdiDi>081259401N72000M5</basicUdiDi>
    <tradeName>NeoShades® with Tabs Phototherapy Eye Shields - Micro</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Neotech Products LLC</manufacturerName>
    <manufacturerSrn>US-MF-000001895</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <emdnCode>V0201</emdnCode>
    <emdnDescription>PHOTOTHERAPY MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N720</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
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    <udiDi>10812594010238</udiDi>
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    <tradeName>NeoShades® with Tabs Phototherapy Eye Shields - Large</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Neotech Products LLC</manufacturerName>
    <manufacturerSrn>US-MF-000001895</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <emdnDescription>PHOTOTHERAPY MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N722</reference>
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    <udiDi>10812594010870</udiDi>
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    <tradeName>NeoShades® with Headstrap Phototherapy Eye Shields - Micro</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Neotech Products LLC</manufacturerName>
    <manufacturerSrn>US-MF-000001895</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
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    <emdnCode>V0201</emdnCode>
    <emdnDescription>PHOTOTHERAPY MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N727</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
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    <basicUdiDi>081259401N72000M5</basicUdiDi>
    <tradeName>NeoShades® with Headstrap Phototherapy Eye Shields - Small</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Neotech Products LLC</manufacturerName>
    <manufacturerSrn>US-MF-000001895</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V0201</emdnCode>
    <emdnDescription>PHOTOTHERAPY MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N728</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:37:52.789Z</lastUpdated>
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    <udiDi>10812594010917</udiDi>
    <basicUdiDi>081259401N72000M5</basicUdiDi>
    <tradeName>NeoShades® with Headstrap Phototherapy Eye Shields - Large</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Neotech Products LLC</manufacturerName>
    <manufacturerSrn>US-MF-000001895</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V0201</emdnCode>
    <emdnDescription>PHOTOTHERAPY MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N729</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:37:52.772Z</lastUpdated>
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