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<eudamedExport entity="devices">
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    <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>
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  <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>
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  <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>
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  <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>
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  <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>08683400978005</udiDi>
    <basicUdiDi>86834009BA7800AU</basicUdiDi>
    <tradeName>ENTPROMED</tradeName>
    <deviceName>Harici Burun Ateli</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>P020203</emdnCode>
    <emdnDescription>NASAL SPLINTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AG 001</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-03T15:14:02.658Z</lastUpdated>
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    <udiDi>00850056079419</udiDi>
    <basicUdiDi>850056079NPU7</basicUdiDi>
    <tradeName>nPLANE™ RAS Conformer - Size 1</tradeName>
    <deviceName>nPLANE™ RAS System</deviceName>
    <manufacturerName>CranioMandibular Rehab, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000039893</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P020203</emdnCode>
    <emdnDescription>NASAL SPLINTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CR5701</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T12:24:23.868Z</lastUpdated>
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  <row>
    <udiDi>08434048516179</udiDi>
    <basicUdiDi>843404825SURGORL3P</basicUdiDi>
    <tradeName>SET MIRINGO REUTER</tradeName>
    <deviceName>Agrupaciones Miringotomía</deviceName>
    <manufacturerName>PRIM, S.A.</manufacturerName>
    <manufacturerSrn>ES-PR-000004648</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P02010201</emdnCode>
    <emdnDescription>TRANSTYMPANIC DRAINAGE PROSTHESES (VENTILATION TUBES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SET2137</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:37:13.770Z</lastUpdated>
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  <row>
    <udiDi>08434048326990</udiDi>
    <basicUdiDi>843404825ORLDILATADORCJ</basicUdiDi>
    <tradeName>Set desechable Balón ETD 6X20</tradeName>
    <deviceName>Agrupaciones Dilatación ORL</deviceName>
    <manufacturerName>PRIM, S.A.</manufacturerName>
    <manufacturerSrn>ES-PR-000004648</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P02010299</emdnCode>
    <emdnDescription>EXTERNAL-MIDDLE EAR IMPLANTS- OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MG0620</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:36:56.967Z</lastUpdated>
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    <udiDi>05060465560384</udiDi>
    <basicUdiDi>506046556120-11AM</basicUdiDi>
    <tradeName>05060465560384</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Medasil Surgical Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000009549</manufacturerSrn>
    <authorisedRepresentativeName>European Healthcare &amp; Device Solutions Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003999</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>P020203</emdnCode>
    <emdnDescription>NASAL SPLINTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>120-1120-3257</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-28T22:10:50.078Z</lastUpdated>
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    <udiDi>05060465560391</udiDi>
    <basicUdiDi>506046556120-10AK</basicUdiDi>
    <tradeName>05060465560391</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Medasil Surgical Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000009549</manufacturerSrn>
    <authorisedRepresentativeName>European Healthcare &amp; Device Solutions Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003999</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>P020203</emdnCode>
    <emdnDescription>NASAL SPLINTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>120-1020-3257</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-28T22:10:50.060Z</lastUpdated>
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    <udiDi>05060465560414</udiDi>
    <basicUdiDi>506046556120-11AM</basicUdiDi>
    <tradeName>05060465560414</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Medasil Surgical Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000009549</manufacturerSrn>
    <authorisedRepresentativeName>European Healthcare &amp; Device Solutions Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003999</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>P020203</emdnCode>
    <emdnDescription>NASAL SPLINTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>120-1120-3260</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-28T22:10:50.042Z</lastUpdated>
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    <udiDi>05060465560421</udiDi>
    <basicUdiDi>506046556120-10AK</basicUdiDi>
    <tradeName>05060465560421</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Medasil Surgical Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000009549</manufacturerSrn>
    <authorisedRepresentativeName>European Healthcare &amp; Device Solutions Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003999</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>P020203</emdnCode>
    <emdnDescription>NASAL SPLINTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>120-1020-3260</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-28T22:10:50.018Z</lastUpdated>
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    <udiDi>05060465560445</udiDi>
    <basicUdiDi>506046556120-11AM</basicUdiDi>
    <tradeName>05060465560445</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Medasil Surgical Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000009549</manufacturerSrn>
    <authorisedRepresentativeName>European Healthcare &amp; Device Solutions Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003999</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>P020203</emdnCode>
    <emdnDescription>NASAL SPLINTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>120-1120-3266</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-28T22:10:49.997Z</lastUpdated>
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    <udiDi>05060465560452</udiDi>
    <basicUdiDi>506046556120-10AK</basicUdiDi>
    <tradeName>05060465560452</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Medasil Surgical Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000009549</manufacturerSrn>
    <authorisedRepresentativeName>European Healthcare &amp; Device Solutions Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003999</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>P020203</emdnCode>
    <emdnDescription>NASAL SPLINTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>120-1020-3266</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-28T22:10:49.979Z</lastUpdated>
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    <udiDi>00385640064729</udiDi>
    <basicUdiDi>03856410497_INTSPLINTSLP</basicUdiDi>
    <tradeName>Breeze</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Summit Medical, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000026771</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P020203</emdnCode>
    <emdnDescription>NASAL SPLINTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SP-79300</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T12:12:23.594Z</lastUpdated>
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