<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00813307013181</udiDi>
    <basicUdiDi>B-00813307013181</basicUdiDi>
    <tradeName>Blom-Singer® 22 Fr Dilator-Sizers (for 20 Fr prostheses)</tradeName>
    <deviceName>Blom-Singer® 22 Fr Dilator-Sizers (for 20 Fr prostheses)</deviceName>
    <manufacturerName>Freudenberg Medical LLC</manufacturerName>
    <manufacturerSrn>US-MF-000023823</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0280</emdnCode>
    <emdnDescription>ENT PROSTHESES- ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BE 2052</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:48:26.754Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813307013174</udiDi>
    <basicUdiDi>B-00813307013174</basicUdiDi>
    <tradeName>Blom-Singer® 18 Fr Dilator-Sizers (for 16 Fr prostheses)</tradeName>
    <deviceName>Blom-Singer® 18 Fr Dilator-Sizers (for 16 Fr prostheses)</deviceName>
    <manufacturerName>Freudenberg Medical LLC</manufacturerName>
    <manufacturerSrn>US-MF-000023823</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0280</emdnCode>
    <emdnDescription>ENT PROSTHESES- ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BE 2051</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:48:25.939Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813307013105</udiDi>
    <basicUdiDi>B-00813307013105</basicUdiDi>
    <tradeName>Blom-Singer® Voice Prosthesis Sizers with 3 inserters (for 20 Fr voice prostheses)</tradeName>
    <deviceName>Blom-Singer® Voice Prosthesis Sizers with 3 inserters (for 20 Fr voice prostheses)</deviceName>
    <manufacturerName>Freudenberg Medical LLC</manufacturerName>
    <manufacturerSrn>US-MF-000023823</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0280</emdnCode>
    <emdnDescription>ENT PROSTHESES- ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BE 2036</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:48:25.131Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813307013099</udiDi>
    <basicUdiDi>B-00813307013099</basicUdiDi>
    <tradeName>Blom-Singer® Voice Prosthesis Sizers with 3 inserters (for 16 Fr voice prostheses)</tradeName>
    <deviceName>Blom-Singer® Voice Prosthesis Sizers with 3 inserters (for 16 Fr voice prostheses)</deviceName>
    <manufacturerName>Freudenberg Medical LLC</manufacturerName>
    <manufacturerSrn>US-MF-000023823</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0280</emdnCode>
    <emdnDescription>ENT PROSTHESES- ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BE 6036</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:48:21.129Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813307011569</udiDi>
    <basicUdiDi>B-00813307011569</basicUdiDi>
    <tradeName>Blom-Singer® 22 Fr Tracheoesophageal Puncture Dilator (for 20 Fr prostheses)</tradeName>
    <deviceName>Blom-Singer® 22 Fr Tracheoesophageal Puncture Dilator (for 20 Fr prostheses)</deviceName>
    <manufacturerName>Freudenberg Medical LLC</manufacturerName>
    <manufacturerSrn>US-MF-000023823</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0280</emdnCode>
    <emdnDescription>ENT PROSTHESES- ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BE 2050</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:48:20.446Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813307011552</udiDi>
    <basicUdiDi>B-00813307011552</basicUdiDi>
    <tradeName>Blom-Singer® 18 Fr Tracheoesophageal Puncture Dilator (for 16 Fr prostheses)</tradeName>
    <deviceName>Blom-Singer® 22 Fr Tracheoesophageal Puncture Dilator (for 20 Fr prostheses)</deviceName>
    <manufacturerName>Freudenberg Medical LLC</manufacturerName>
    <manufacturerSrn>US-MF-000023823</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0280</emdnCode>
    <emdnDescription>ENT PROSTHESES- ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BE 6050</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:48:18.739Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813307010845</udiDi>
    <basicUdiDi>B-00813307010845</basicUdiDi>
    <tradeName>Blom-Singer® Advantage Indwelling 20 Fr. (Hard Valve) Voice Prosthesis, 4mm</tradeName>
    <deviceName>Blom-Singer® Advantage Indwelling 20 Fr. (Hard Valve) Voice Prosthesis, 4mm</deviceName>
    <manufacturerName>Freudenberg Medical LLC</manufacturerName>
    <manufacturerSrn>US-MF-000023823</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0204</emdnCode>
    <emdnDescription>LARYNX PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AD 2004-NS</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:48:17.949Z</lastUpdated>
  </row>
  <row>
    <udiDi>00848253001067</udiDi>
    <basicUdiDi>08482530GELCAPSJ6</basicUdiDi>
    <tradeName>Blom-Singer Replacement Gel Caps, 18 Fr.</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Freudenberg Medical LLC</manufacturerName>
    <manufacturerSrn>US-MF-000023823</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ENT PROSTHESES- ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BE 3195</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:25:59.769Z</lastUpdated>
  </row>
  <row>
    <udiDi>00848253002071</udiDi>
    <basicUdiDi>08482530DAY&amp;NIGHTVZ</basicUdiDi>
    <tradeName>Blom-Singer Day&amp;Night ClassicFlow</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Freudenberg Medical LLC</manufacturerName>
    <manufacturerSrn>US-MF-000023823</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>TRACHEOSTOMY HUMIDIFIERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BE 1091</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:25:59.747Z</lastUpdated>
  </row>
  <row>
    <udiDi>00848253002101</udiDi>
    <basicUdiDi>08482530SEPTALNL</basicUdiDi>
    <tradeName>Nasal Septal Perforation Prosthesis, Round, 7mm x 2mm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Freudenberg Medical LLC</manufacturerName>
    <manufacturerSrn>US-MF-000023823</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>NASAL SEPTAL PLUGGERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SP 1072</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:25:59.726Z</lastUpdated>
  </row>
  <row>
    <udiDi>00848253002118</udiDi>
    <basicUdiDi>08482530SEPTALNL</basicUdiDi>
    <tradeName>Nasal Septal Perforation Prosthesis, Round, 7mm x 3mm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Freudenberg Medical LLC</manufacturerName>
    <manufacturerSrn>US-MF-000023823</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>NASAL SEPTAL PLUGGERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SP 1073</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:25:59.702Z</lastUpdated>
  </row>
  <row>
    <udiDi>00848253002125</udiDi>
    <basicUdiDi>08482530SEPTALNL</basicUdiDi>
    <tradeName>Nasal Septal Perforation Prosthesis, Round, 10mm x 2mm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Freudenberg Medical LLC</manufacturerName>
    <manufacturerSrn>US-MF-000023823</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>NASAL SEPTAL PLUGGERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SP 1102</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:25:59.672Z</lastUpdated>
  </row>
  <row>
    <udiDi>00848253002132</udiDi>
    <basicUdiDi>08482530SEPTALNL</basicUdiDi>
    <tradeName>Nasal Septal Perforation Prosthesis, Round, 10mm x 3mm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Freudenberg Medical LLC</manufacturerName>
    <manufacturerSrn>US-MF-000023823</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>NASAL SEPTAL PLUGGERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SP 1103</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:25:59.643Z</lastUpdated>
  </row>
  <row>
    <udiDi>00848253002149</udiDi>
    <basicUdiDi>08482530SEPTALNL</basicUdiDi>
    <tradeName>Nasal Septal Perforation Prosthesis, Oval, 11mm x 13mm x 2mm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Freudenberg Medical LLC</manufacturerName>
    <manufacturerSrn>US-MF-000023823</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>NASAL SEPTAL PLUGGERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SP 2112</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:25:59.618Z</lastUpdated>
  </row>
  <row>
    <udiDi>00848253002156</udiDi>
    <basicUdiDi>08482530SEPTALNL</basicUdiDi>
    <tradeName>Nasal Septal Perforation Prosthesis, Oval, 11mm x 13mm x 3mm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Freudenberg Medical LLC</manufacturerName>
    <manufacturerSrn>US-MF-000023823</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>NASAL SEPTAL PLUGGERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SP 2113</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:25:59.593Z</lastUpdated>
  </row>
  <row>
    <udiDi>00848253002163</udiDi>
    <basicUdiDi>08482530SEPTALNL</basicUdiDi>
    <tradeName>Nasal Septal Perforation Prosthesis, Oval, 13mm x 17mm x 2mm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Freudenberg Medical LLC</manufacturerName>
    <manufacturerSrn>US-MF-000023823</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>NASAL SEPTAL PLUGGERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SP 2132</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:25:59.567Z</lastUpdated>
  </row>
  <row>
    <udiDi>00848253002170</udiDi>
    <basicUdiDi>08482530SEPTALNL</basicUdiDi>
    <tradeName>Nasal Septal Perforation Prosthesis, Oval, 13mm x 17mm x 3mm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Freudenberg Medical LLC</manufacturerName>
    <manufacturerSrn>US-MF-000023823</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>NASAL SEPTAL PLUGGERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SP 2133</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:25:59.536Z</lastUpdated>
  </row>
  <row>
    <udiDi>00848253002187</udiDi>
    <basicUdiDi>08482530SEPTALNL</basicUdiDi>
    <tradeName>Nasal Septal Perforation Prosthesis, Oval, 15mm x 21mm x 2mm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Freudenberg Medical LLC</manufacturerName>
    <manufacturerSrn>US-MF-000023823</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>NASAL SEPTAL PLUGGERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SP 2152</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:25:59.502Z</lastUpdated>
  </row>
  <row>
    <udiDi>00848253002194</udiDi>
    <basicUdiDi>08482530SEPTALNL</basicUdiDi>
    <tradeName>Nasal Septal Perforation Prosthesis, Oval, 15mm x 21mm x 3mm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Freudenberg Medical LLC</manufacturerName>
    <manufacturerSrn>US-MF-000023823</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>NASAL SEPTAL PLUGGERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SP 2153</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:25:59.477Z</lastUpdated>
  </row>
  <row>
    <udiDi>00848253002200</udiDi>
    <basicUdiDi>08482530SPEAKFREEGJ</basicUdiDi>
    <tradeName>SpeakFree HME ClassicFlow, 30 pack</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Freudenberg Medical LLC</manufacturerName>
    <manufacturerSrn>US-MF-000023823</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>TRACHEOSTOMY HUMIDIFIERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BE 1090EZ</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:25:59.456Z</lastUpdated>
  </row>
</eudamedExport>