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    <tradeName>nPLANE™ Training Conformer (Size 03L)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CranioMandibular Rehab, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000039893</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
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    <legislation>MDR 2017/745</legislation>
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    <basicUdiDi>850056079NPU7</basicUdiDi>
    <tradeName>nPLANE™ Training Kit</tradeName>
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    <manufacturerName>CranioMandibular Rehab, Inc.</manufacturerName>
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    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <udiDi>00848253000954</udiDi>
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    <tradeName>Adjustable Bi-Flanged Fistula Prosthesis - 38mm</tradeName>
    <deviceName>Adjustable Bi-Flanged Fistula Prosthesis - 38mm</deviceName>
    <manufacturerName>Freudenberg Medical LLC</manufacturerName>
    <manufacturerSrn>US-MF-000023823</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
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    <udiDi>00813307011606</udiDi>
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    <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>
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    <emdnDescription>ENT PROSTHESES- ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IN 4070</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:26:17.342Z</lastUpdated>
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    <udiDi>09120117860012</udiDi>
    <basicUdiDi>912011786UVAHN</basicUdiDi>
    <tradeName>VOIS-XS</tradeName>
    <deviceName>VOIS Implants</deviceName>
    <manufacturerName>APrevent Biotech GmbH</manufacturerName>
    <manufacturerSrn>AT-MF-000001435</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P0204</emdnCode>
    <emdnDescription>LARYNX PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>APV001</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-16T09:54:47.992Z</lastUpdated>
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    <udiDi>04034393807485</udiDi>
    <basicUdiDi>4034393CPTENT2AYN</basicUdiDi>
    <tradeName>Septum NNH-Set</tradeName>
    <deviceName>Tympanoplastik-Set</deviceName>
    <manufacturerName>Sengewald Klinikprodukte GmbH</manufacturerName>
    <manufacturerSrn>DE-PR-000020748</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P020201</emdnCode>
    <emdnDescription>NASAL SEPTAL PLUGGERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6689869-11</reference>
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    <lastUpdated>2026-07-16T05:11:06.876Z</lastUpdated>
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    <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>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>BE 8020</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:02:58.152Z</lastUpdated>
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    <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>
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    <legislation>MDR 2017/745</legislation>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>BE 6096</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T02:58:44.931Z</lastUpdated>
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    <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>
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    <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>
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    <udiDi>00813307013013</udiDi>
    <basicUdiDi>08482530SEPTALNL</basicUdiDi>
    <tradeName>Nasal Septal Perforation Prosthesis, Round, 5mm x 2mm</tradeName>
    <deviceName>SEPTAL</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>P020201</emdnCode>
    <emdnDescription>NASAL SEPTAL PLUGGERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SP 1052</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T02:58:39.350Z</lastUpdated>
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    <udiDi>00385640086691</udiDi>
    <basicUdiDi>03856492982_DENVERSPKA</basicUdiDi>
    <tradeName>The Denver Splint 1500</tradeName>
    <deviceName>The Denver Splint (Kit)</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>10-1500-05KL-C</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:45:34.979Z</lastUpdated>
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    <udiDi>00385640045841</udiDi>
    <basicUdiDi>03856492982_DENVERSPNKNL</basicUdiDi>
    <tradeName>The Denver Splint Thermoplastic</tradeName>
    <deviceName>The Denver Splint (Non-Kit)</deviceName>
    <manufacturerName>Summit Medical, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000026771</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
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    <legislation>MDR 2017/745</legislation>
    <emdnCode>P020203</emdnCode>
    <emdnDescription>NASAL SPLINTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AQ-9X12-21</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:45:31.062Z</lastUpdated>
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    <basicUdiDi>03856410497_INTSPLINTSLP</basicUdiDi>
    <tradeName>00385640000031</tradeName>
    <deviceName>Internal Nasal Splints</deviceName>
    <manufacturerName>Summit Medical, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000026771</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
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    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P020203</emdnCode>
    <emdnDescription>NASAL SPLINTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SP-27000</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:45:12.369Z</lastUpdated>
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    <tradeName>Ferris-Smith-Kerrison</tradeName>
    <deviceName>Ferris-Smith-Kerrison</deviceName>
    <manufacturerName>FHQ Trading CO.</manufacturerName>
    <manufacturerSrn>PK-MF-000033179</manufacturerSrn>
    <authorisedRepresentativeName>ANTEX MEDI SOLUTION</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000008078</authorisedRepresentativeSrn>
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    <legislation>MDR 2017/745</legislation>
    <emdnCode>P020299</emdnCode>
    <emdnDescription>RHINOLOGY PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20-356-17-07</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T18:06:10.507Z</lastUpdated>
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    <tradeName>VOIS-S</tradeName>
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    <manufacturerName>APrevent Biotech GmbH</manufacturerName>
    <manufacturerSrn>AT-MF-000001435</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>APV002</reference>
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    <lastUpdated>2026-07-11T12:57:35.463Z</lastUpdated>
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    <tradeName>VOIS-M</tradeName>
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    <manufacturerName>APrevent Biotech GmbH</manufacturerName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>APV003</reference>
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    <lastUpdated>2026-07-11T12:57:35.424Z</lastUpdated>
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    <tradeName>VOIS-L</tradeName>
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    <manufacturerName>APrevent Biotech GmbH</manufacturerName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <deviceStatus>Piyasada</deviceStatus>
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    <tradeName>VOIS-S_3.0</tradeName>
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    <manufacturerName>APrevent Biotech GmbH</manufacturerName>
    <manufacturerSrn>AT-MF-000001435</manufacturerSrn>
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    <legislation>MDR 2017/745</legislation>
    <emdnCode>P0204</emdnCode>
    <emdnDescription>LARYNX PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>APV009</reference>
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