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    <tradeName>05060465560308</tradeName>
    <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>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P020203</emdnCode>
    <emdnDescription>NASAL SPLINTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>120-1020-2257</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:52:01.706Z</lastUpdated>
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    <udiDi>05060465560292</udiDi>
    <basicUdiDi>506046556120-11AM</basicUdiDi>
    <tradeName>05060465560292</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>120-1120-2257</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:47:17.932Z</lastUpdated>
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    <udiDi>00850056079761</udiDi>
    <basicUdiDi>850056079NPU7</basicUdiDi>
    <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>
    <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>CR5705L</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:36:04.906Z</lastUpdated>
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    <udiDi>00850056079785</udiDi>
    <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>05060465560322</udiDi>
    <basicUdiDi>506046556120-11AM</basicUdiDi>
    <tradeName>05060465560322</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>120-1120-2260</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-19T15:28:19.387Z</lastUpdated>
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    <udiDi>05060465560339</udiDi>
    <basicUdiDi>506046556120-10AK</basicUdiDi>
    <tradeName>05060465560339</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>120-1020-2060</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-19T15:28:19.363Z</lastUpdated>
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    <udiDi>05060465560353</udiDi>
    <basicUdiDi>506046556120-11AM</basicUdiDi>
    <tradeName>05060465560353</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>120-1120-2266</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-19T15:28:19.337Z</lastUpdated>
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    <udiDi>05060465560360</udiDi>
    <basicUdiDi>506046556120-10AK</basicUdiDi>
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    <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>120-1020-2266</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-19T15:28:19.297Z</lastUpdated>
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    <udiDi>00850056079426</udiDi>
    <basicUdiDi>850056079NPU7</basicUdiDi>
    <tradeName>nPLANE™ RAS Conformer - Size 2</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>CR5702</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T06:21:02.332Z</lastUpdated>
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    <udiDi>00850056079433</udiDi>
    <basicUdiDi>850056079NPU7</basicUdiDi>
    <tradeName>nPLANE™ RAS Conformer - Size 3</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>CR5703</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T06:19:29.846Z</lastUpdated>
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    <udiDi>00850056079440</udiDi>
    <basicUdiDi>850056079NPU7</basicUdiDi>
    <tradeName>nPLANE™ RAS Conformer - Size 3 LEFT</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>CR5703L</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T06:19:29.820Z</lastUpdated>
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    <udiDi>00850056079457</udiDi>
    <basicUdiDi>850056079NPU7</basicUdiDi>
    <tradeName>nPLANE™ RAS Conformer - Size 3 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>CR5703R</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T06:19:29.794Z</lastUpdated>
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    <udiDi>00850056079464</udiDi>
    <basicUdiDi>850056079NPU7</basicUdiDi>
    <tradeName>nPLANE™ RAS Conformer - Size 4</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>CR5704</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T06:19:29.771Z</lastUpdated>
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    <udiDi>00850056079471</udiDi>
    <basicUdiDi>850056079NPU7</basicUdiDi>
    <tradeName>nPLANE™ RAS Conformer - Size 4 LEFT</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>CR5704L</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T06:19:29.742Z</lastUpdated>
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    <udiDi>00850056079488</udiDi>
    <basicUdiDi>850056079NPU7</basicUdiDi>
    <tradeName>nPLANE™ RAS Conformer - Size 4 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>CR5704R</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T06:19:29.718Z</lastUpdated>
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    <udiDi>00850056079501</udiDi>
    <basicUdiDi>850056079NPU7</basicUdiDi>
    <tradeName>nPLANE™ RAS Unilateral Kit - 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>CR5715</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T06:19:29.688Z</lastUpdated>
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    <udiDi>00850056079518</udiDi>
    <basicUdiDi>850056079NPU7</basicUdiDi>
    <tradeName>nPLANE™ RAS Symmetrical Bilateral Kit</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>CR5720</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T06:19:29.664Z</lastUpdated>
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    <udiDi>00850056079792</udiDi>
    <basicUdiDi>850056079NPU7</basicUdiDi>
    <tradeName>nPLANE™ Clinic Kit - 7 Patient</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>CR575007</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T06:19:29.636Z</lastUpdated>
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    <udiDi>00850056079808</udiDi>
    <basicUdiDi>850056079NPU7</basicUdiDi>
    <tradeName>nPLANE™ Clinic Kit - 10 Patient</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>CR575010</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T06:19:29.610Z</lastUpdated>
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