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<eudamedExport entity="devices">
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    <basicUdiDi>081259401N72000M5</basicUdiDi>
    <tradeName>NeoShades® with Tabs Phototherapy Eye Shields - Large Plain</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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N726PL</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:37:50.622Z</lastUpdated>
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    <udiDi>10812594013192</udiDi>
    <basicUdiDi>081259401N72000M5</basicUdiDi>
    <tradeName>NeoShades® with Headstrap Phototherapy Eye Shields - Micro Plain</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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N727PL</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:37:50.600Z</lastUpdated>
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  <row>
    <udiDi>10812594013208</udiDi>
    <basicUdiDi>081259401N72000M5</basicUdiDi>
    <tradeName>NeoShades® with Headstrap Phototherapy Eye Shields - Small Plain</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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N728PL</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:37:50.579Z</lastUpdated>
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    <udiDi>10812594013215</udiDi>
    <basicUdiDi>081259401N72000M5</basicUdiDi>
    <tradeName>NeoShades® with Headstrap Phototherapy Eye Shields - Large Plain</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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N729PL</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:37:50.563Z</lastUpdated>
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  <row>
    <udiDi>10812594013437</udiDi>
    <basicUdiDi>081259401N73100MH</basicUdiDi>
    <tradeName>NeoSmile™ Hydrogel - Temperature Probe Cover</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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N7321</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:37:50.533Z</lastUpdated>
  </row>
  <row>
    <udiDi>10812594011488</udiDi>
    <basicUdiDi>081259401N78100NL</basicUdiDi>
    <tradeName>NeoPulse™ Disposable Pulse Oximeter Wrap - 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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N781</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T17:56:28.840Z</lastUpdated>
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  <row>
    <udiDi>10812594011501</udiDi>
    <basicUdiDi>081259401N78100NL</basicUdiDi>
    <tradeName>NeoPulse™ Disposable Pulse Oximeter Wrap - 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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N782</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T17:56:28.819Z</lastUpdated>
  </row>
  <row>
    <udiDi>10812594011990</udiDi>
    <basicUdiDi>081259401N78100NL</basicUdiDi>
    <tradeName>NeoPulse™ Disposable Pulse Oximeter Wrap - Extra 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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N783</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T17:56:28.792Z</lastUpdated>
  </row>
  <row>
    <udiDi>10812594011273</udiDi>
    <basicUdiDi>081259401N49000MM</basicUdiDi>
    <tradeName>RAM Cannula® - Nasal Oxygen Cannula - Preemie</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 IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N4901</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T13:56:49.430Z</lastUpdated>
  </row>
  <row>
    <udiDi>10812594011297</udiDi>
    <basicUdiDi>081259401N49000MM</basicUdiDi>
    <tradeName>RAM Cannula® - Nasal Oxygen Cannula - New Born</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 IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N4902</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T13:56:49.413Z</lastUpdated>
  </row>
  <row>
    <udiDi>10812594011310</udiDi>
    <basicUdiDi>081259401N49000MM</basicUdiDi>
    <tradeName>RAM Cannula® - Nasal Oxygen Cannula - Infant</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 IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N4903</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T13:56:49.388Z</lastUpdated>
  </row>
  <row>
    <udiDi>10812594011921</udiDi>
    <basicUdiDi>081259401N49000MM</basicUdiDi>
    <tradeName>RAM Cannula® - Nasal Oxygen Cannula - Micro Preemie</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 IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N4900</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T13:56:49.367Z</lastUpdated>
  </row>
  <row>
    <udiDi>10812594012034</udiDi>
    <basicUdiDi>081259401N49000MM</basicUdiDi>
    <tradeName>RAM Cannula® - Nasal Oxygen Cannula - Pediatric 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 IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N4904</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T13:56:49.346Z</lastUpdated>
  </row>
  <row>
    <udiDi>10812594012041</udiDi>
    <basicUdiDi>081259401N49000MM</basicUdiDi>
    <tradeName>RAM Cannula® - Nasal Oxygen Cannula - Pediatric Medium</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 IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N4905</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T13:56:49.323Z</lastUpdated>
  </row>
  <row>
    <udiDi>10812594012058</udiDi>
    <basicUdiDi>081259401N49000MM</basicUdiDi>
    <tradeName>RAM Cannula® - Nasal Oxygen Cannula - Pediatric 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 IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N4906</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T13:56:49.288Z</lastUpdated>
  </row>
  <row>
    <udiDi>20812594012604</udiDi>
    <basicUdiDi>081259401N80010M5</basicUdiDi>
    <tradeName>Neotech Bridge®</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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>N8001-30</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T22:16:41.421Z</lastUpdated>
  </row>
  <row>
    <udiDi>20812594012925</udiDi>
    <basicUdiDi>081259401N70150MB</basicUdiDi>
    <tradeName>NeoSnug</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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N7015-15</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T22:16:41.398Z</lastUpdated>
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    <udiDi>20812594013236</udiDi>
    <basicUdiDi>081259401N70150MB</basicUdiDi>
    <tradeName>NeoSnug</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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N7014-15</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T22:16:41.376Z</lastUpdated>
  </row>
  <row>
    <udiDi>20812594013243</udiDi>
    <basicUdiDi>081259401N70150MB</basicUdiDi>
    <tradeName>NeoSnug</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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N7025-40</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T22:16:41.346Z</lastUpdated>
  </row>
  <row>
    <udiDi>00812594012679</udiDi>
    <basicUdiDi>081259401N55100M9</basicUdiDi>
    <tradeName>NeoGlo® Aqua Transilluminator</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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N555AQ</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-19T19:48:48.964Z</lastUpdated>
  </row>
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