<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00813307011590</udiDi>
    <basicUdiDi>B-00813307011590</basicUdiDi>
    <tradeName>Blom-Singer® Plug Inserts 16 Fr.</tradeName>
    <deviceName>Blom-Singer® Plug Inserts 16 Fr.</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>IN 4069</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-25T10:18:07.264Z</lastUpdated>
  </row>
  <row>
    <udiDi>00848253003191</udiDi>
    <basicUdiDi>08482530GELCAPSJ6</basicUdiDi>
    <tradeName>Blom-Singer  Replacement Gel  Caps, 22 Fr</tradeName>
    <deviceName>GELCAPS</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>MDR 2017/745</legislation>
    <emdnCode>P0280</emdnCode>
    <emdnDescription>ENT PROSTHESES- ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BE 3295</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-23T15:09:39.270Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813307011606</udiDi>
    <basicUdiDi>B-00813307011606</basicUdiDi>
    <tradeName>Blom-Singer® Plug Inserts 20 Fr.</tradeName>
    <deviceName>Blom-Singer® Plug Inserts 20 Fr.</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>IN 4070</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:26:17.342Z</lastUpdated>
  </row>
  <row>
    <udiDi>00848253002835</udiDi>
    <basicUdiDi>08482530MANOMETERADAPTZG</basicUdiDi>
    <tradeName>Blom-Singer Replacement Manometer Adaptors</tradeName>
    <deviceName>MANAMOMETERADAPT</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>MDR 2017/745</legislation>
    <emdnCode>P0280</emdnCode>
    <emdnDescription>ENT PROSTHESES- ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BE 8020</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:02:58.152Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813307013112</udiDi>
    <basicUdiDi>08482530INSERTERSTICKSW3</basicUdiDi>
    <tradeName>Replacement Inserter Sticks</tradeName>
    <deviceName>INSERTERSTICKS</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>MDR 2017/745</legislation>
    <emdnCode>P0280</emdnCode>
    <emdnDescription>ENT PROSTHESES- ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BE 6096</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T02:58:44.931Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813307013075</udiDi>
    <basicUdiDi>08482530MANOMETERFD</basicUdiDi>
    <tradeName>Blom-Singer Manometer Kit</tradeName>
    <deviceName>MANOMETER</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>MDR 2017/745</legislation>
    <emdnCode>P0280</emdnCode>
    <emdnDescription>ENT PROSTHESES- ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BE 8000</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T02:58:44.133Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813307013051</udiDi>
    <basicUdiDi>08482530INSUFFLATION5H</basicUdiDi>
    <tradeName>Blom-Singer Insufflation Test Set</tradeName>
    <deviceName>INSUFFLATION</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>MDR 2017/745</legislation>
    <emdnCode>P0280</emdnCode>
    <emdnDescription>ENT PROSTHESES- ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BE 6040</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T02:58:43.331Z</lastUpdated>
  </row>
  <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>08904428744947</udiDi>
    <basicUdiDi>89044287NTH63</basicUdiDi>
    <tradeName>Osseous</tradeName>
    <deviceName>Neck Fit Tube Holder</deviceName>
    <manufacturerName>EON MEDITECH PVT. LTD</manufacturerName>
    <manufacturerSrn>IN-MF-000014457</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P0280</emdnCode>
    <emdnDescription>ENT PROSTHESES- ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EA91053</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:33:33.091Z</lastUpdated>
  </row>
  <row>
    <udiDi>08684000857332</udiDi>
    <basicUdiDi>86840008NR5733J9</basicUdiDi>
    <tradeName>ENTPROMED</tradeName>
    <deviceName>Nostril Retainer</deviceName>
    <manufacturerName>ENTPROMED SAĞLIK ÜRÜNLERİ SAN. VE TİC. A.Ş.</manufacturerName>
    <manufacturerSrn>TR-MF-000022407</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P0280</emdnCode>
    <emdnDescription>ENT PROSTHESES- ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ENR07</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-03T15:16:41.968Z</lastUpdated>
  </row>
  <row>
    <udiDi>08684000857349</udiDi>
    <basicUdiDi>86840008NR5733J9</basicUdiDi>
    <tradeName>ENTPROMED</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ENTPROMED SAĞLIK ÜRÜNLERİ SAN. VE TİC. A.Ş.</manufacturerName>
    <manufacturerSrn>TR-MF-000022407</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P0280</emdnCode>
    <emdnDescription>ENT PROSTHESES- ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ENR08</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T20:08:36.073Z</lastUpdated>
  </row>
  <row>
    <udiDi>08684000857356</udiDi>
    <basicUdiDi>86840008NR5733J9</basicUdiDi>
    <tradeName>ENTPROMED</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ENTPROMED SAĞLIK ÜRÜNLERİ SAN. VE TİC. A.Ş.</manufacturerName>
    <manufacturerSrn>TR-MF-000022407</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P0280</emdnCode>
    <emdnDescription>ENT PROSTHESES- ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ENR09</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T20:08:36.042Z</lastUpdated>
  </row>
</eudamedExport>