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    <manufacturerName>Qfix</manufacturerName>
    <manufacturerSrn>US-MF-000002762</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
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    <emdnDescription>NASAL SPLINTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PS-1300</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:32:09.071Z</lastUpdated>
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    <basicUdiDi>506046556120-10AK</basicUdiDi>
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    <deviceName>Non Sterile-Silicone Nasal Splints</deviceName>
    <manufacturerName>Medasil Surgical Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000009549</manufacturerSrn>
    <authorisedRepresentativeName>European Healthcare &amp; Device Solutions Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003999</authorisedRepresentativeSrn>
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    <legislation>MDR 2017/745</legislation>
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    <reference>120-1020-2257</reference>
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    <udiDi>05060465560292</udiDi>
    <basicUdiDi>506046556120-11AM</basicUdiDi>
    <tradeName>05060465560292</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Medasil Surgical Limited</manufacturerName>
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    <authorisedRepresentativeName>European Healthcare &amp; Device Solutions Ltd.</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>120-1120-2257</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
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    <tradeName>Przyrząd do drenażu jamy bębenkowej ucha środkowego</tradeName>
    <deviceName>Przyrząd do drenażu jamy bębenkowej ucha środkowego</deviceName>
    <manufacturerName>Zakład Detali Medycznych "DEMED" Sp. z o.o.</manufacturerName>
    <manufacturerSrn>PL-MF-000023923</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P02010201</emdnCode>
    <emdnDescription>TRANSTYMPANIC DRAINAGE PROSTHESES (VENTILATION TUBES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>301</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-29T07:55:00.226Z</lastUpdated>
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    <basicUdiDi>B-05905947570003</basicUdiDi>
    <tradeName>Przyrząd do drenażu jamy bębenkowej ucha środkowego</tradeName>
    <deviceName>Przyrząd do drenażu jamy bębenkowej ucha środkowego</deviceName>
    <manufacturerName>Zakład Detali Medycznych "DEMED" Sp. z o.o.</manufacturerName>
    <manufacturerSrn>PL-MF-000023923</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P02010201</emdnCode>
    <emdnDescription>TRANSTYMPANIC DRAINAGE PROSTHESES (VENTILATION TUBES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>302</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-29T07:54:56.225Z</lastUpdated>
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    <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>
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    <tradeName>nPLANE™ RAS Conformer - Size 5</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>CR5705</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:59:46.003Z</lastUpdated>
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    <basicUdiDi>850056079NPU7</basicUdiDi>
    <tradeName>nPLANE™ RAS Conformer - Size 5 LEFT</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>
    <emdnCode>P020203</emdnCode>
    <emdnDescription>NASAL SPLINTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CR5705L</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:36:04.906Z</lastUpdated>
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    <basicUdiDi>850056079NPU7</basicUdiDi>
    <tradeName>nPLANE™ RAS Conformer - Size 5 RIGHT</tradeName>
    <deviceName></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>CR5705R</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:36:04.340Z</lastUpdated>
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    <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>
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    <udiDi>00848253000947</udiDi>
    <basicUdiDi>B-00848253000947</basicUdiDi>
    <tradeName>Adjustable Bi-Flanged Fistula Prosthesis - 25mm</tradeName>
    <deviceName>Adjustable Bi-Flanged Fistula Prosthesis - 25mm</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>P0299</emdnCode>
    <emdnDescription>ENT PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FM-1003</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-23T15:09:38.470Z</lastUpdated>
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    <udiDi>14063107101868</udiDi>
    <basicUdiDi>B-14063107101868</basicUdiDi>
    <tradeName>Montgomery Thyroplasty Implant</tradeName>
    <deviceName>Montgomery Thyroplasty Implant</deviceName>
    <manufacturerName>Boston Medical Products, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017994</manufacturerSrn>
    <authorisedRepresentativeName>bess medizintechnik gmbh</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006514</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0204</emdnCode>
    <emdnDescription>LARYNX PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MTM-13</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-23T07:09:36.138Z</lastUpdated>
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    <basicUdiDi>B-14063107101851</basicUdiDi>
    <tradeName>Montgomery Thyroplasty Implant</tradeName>
    <deviceName>Montgomery Thyroplasty Implant</deviceName>
    <manufacturerName>Boston Medical Products, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017994</manufacturerSrn>
    <authorisedRepresentativeName>bess medizintechnik gmbh</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006514</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0204</emdnCode>
    <emdnDescription>LARYNX PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MTM-12</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-23T07:09:33.720Z</lastUpdated>
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    <basicUdiDi>B-14063107101844</basicUdiDi>
    <tradeName>Montgomery Thyroplasty Implant</tradeName>
    <deviceName>Montgomery Thyroplasty Implant</deviceName>
    <manufacturerName>Boston Medical Products, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017994</manufacturerSrn>
    <authorisedRepresentativeName>bess medizintechnik gmbh</authorisedRepresentativeName>
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    <riskClass>Sınıf IIb</riskClass>
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    <emdnCode>P0204</emdnCode>
    <emdnDescription>LARYNX PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MTM-11</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-23T07:09:32.920Z</lastUpdated>
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    <basicUdiDi>B-14063107101837</basicUdiDi>
    <tradeName>Montgomery Thyroplasty Implant</tradeName>
    <deviceName>Montgomery Thyroplasty Implant</deviceName>
    <manufacturerName>Boston Medical Products, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017994</manufacturerSrn>
    <authorisedRepresentativeName>bess medizintechnik gmbh</authorisedRepresentativeName>
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    <emdnCode>P0204</emdnCode>
    <emdnDescription>LARYNX PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MTM-10</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-23T07:09:32.116Z</lastUpdated>
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    <basicUdiDi>B-14063107101820</basicUdiDi>
    <tradeName>Montgomery Thyroplasty Implant</tradeName>
    <deviceName>Montgomery Thyroplasty Implant</deviceName>
    <manufacturerName>Boston Medical Products, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017994</manufacturerSrn>
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    <emdnCode>P0204</emdnCode>
    <emdnDescription>LARYNX PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MTM-09</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-23T07:09:28.115Z</lastUpdated>
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    <tradeName>Montgomery Thyroplasty Implant</tradeName>
    <deviceName>Montgomery Thyroplasty Implant</deviceName>
    <manufacturerName>Boston Medical Products, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017994</manufacturerSrn>
    <authorisedRepresentativeName>bess medizintechnik gmbh</authorisedRepresentativeName>
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    <emdnCode>P0204</emdnCode>
    <emdnDescription>LARYNX PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MTM-08</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-23T07:09:27.325Z</lastUpdated>
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    <tradeName>Montgomery Thyroplasty Implant</tradeName>
    <deviceName>Montgomery Thyroplasty Implant</deviceName>
    <manufacturerName>Boston Medical Products, Inc.</manufacturerName>
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    <emdnCode>P0204</emdnCode>
    <emdnDescription>LARYNX PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MTF-11</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-23T07:09:26.519Z</lastUpdated>
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    <tradeName>Montgomery Thyroplasty Implant</tradeName>
    <deviceName>Montgomery Thyroplasty Implant</deviceName>
    <manufacturerName>Boston Medical Products, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017994</manufacturerSrn>
    <authorisedRepresentativeName>bess medizintechnik gmbh</authorisedRepresentativeName>
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    <emdnCode>P0204</emdnCode>
    <emdnDescription>LARYNX PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MTF-10</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-23T07:09:23.316Z</lastUpdated>
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    <tradeName>Montgomery Thyroplasty Implant</tradeName>
    <deviceName>Montgomery Thyroplasty Implant</deviceName>
    <manufacturerName>Boston Medical Products, Inc.</manufacturerName>
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    <authorisedRepresentativeName>bess medizintechnik gmbh</authorisedRepresentativeName>
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    <emdnCode>P0204</emdnCode>
    <emdnDescription>LARYNX PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MTF-09</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-23T07:09:22.534Z</lastUpdated>
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