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<eudamedExport entity="devices">
  <row>
    <udiDi>00768627015257</udiDi>
    <basicUdiDi>0768627CSTACC-4279-TL</basicUdiDi>
    <tradeName>Outrigger Line Connectors</tradeName>
    <deviceName>Outrigger Line Connectors</deviceName>
    <manufacturerName>North Coast Medical Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000009087</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>M030504</emdnCode>
    <emdnDescription>IMMOBILISATION SYSTEMS, MOULDABLE UNDER COLD AND HOT TEMPRATURES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NC12494</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:18:25.498Z</lastUpdated>
  </row>
  <row>
    <udiDi>00768627015226</udiDi>
    <basicUdiDi>0768627CSTACC-628-8U</basicUdiDi>
    <tradeName>Rubber Band Posts with Thumb Screws</tradeName>
    <deviceName>Rubber Band Posts with Thumb Screws</deviceName>
    <manufacturerName>North Coast Medical Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000009087</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>M030504</emdnCode>
    <emdnDescription>IMMOBILISATION SYSTEMS, MOULDABLE UNDER COLD AND HOT TEMPRATURES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NC12762</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:18:23.067Z</lastUpdated>
  </row>
  <row>
    <udiDi>00768627015134</udiDi>
    <basicUdiDi>0768627CSTACC-1652-SG</basicUdiDi>
    <tradeName>Base 2 Outrigger Components</tradeName>
    <deviceName>Base 2 Outrigger Components</deviceName>
    <manufacturerName>North Coast Medical Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000009087</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>M030504</emdnCode>
    <emdnDescription>IMMOBILISATION SYSTEMS, MOULDABLE UNDER COLD AND HOT TEMPRATURES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NC12830-3</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:18:21.471Z</lastUpdated>
  </row>
  <row>
    <udiDi>00768627015110</udiDi>
    <basicUdiDi>0768627CSTACC-688-9S</basicUdiDi>
    <tradeName>Phoenix Outrigger Kit</tradeName>
    <deviceName>Phoenix Outrigger Kit</deviceName>
    <manufacturerName>North Coast Medical Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000009087</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>M030504</emdnCode>
    <emdnDescription>IMMOBILISATION SYSTEMS, MOULDABLE UNDER COLD AND HOT TEMPRATURES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NC12760</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:18:20.684Z</lastUpdated>
  </row>
  <row>
    <udiDi>00768627012621</udiDi>
    <basicUdiDi>0768627CSTACC-3851-TH</basicUdiDi>
    <tradeName>Preferred Blk, 1/8" Smooth, 18x24 (4)</tradeName>
    <deviceName>Preferred Black</deviceName>
    <manufacturerName>North Coast Medical Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000009087</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>M030504</emdnCode>
    <emdnDescription>IMMOBILISATION SYSTEMS, MOULDABLE UNDER COLD AND HOT TEMPRATURES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NC12813</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:17:50.329Z</lastUpdated>
  </row>
  <row>
    <udiDi>00768627010542</udiDi>
    <basicUdiDi>0768627CSTACC-647-93</basicUdiDi>
    <tradeName>Ultra-Suede Finger Slings</tradeName>
    <deviceName>Ultra-Suede Finger Slings</deviceName>
    <manufacturerName>North Coast Medical Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000009087</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>M030504</emdnCode>
    <emdnDescription>IMMOBILISATION SYSTEMS, MOULDABLE UNDER COLD AND HOT TEMPRATURES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NC12338</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:17:37.412Z</lastUpdated>
  </row>
  <row>
    <udiDi>00768627009980</udiDi>
    <basicUdiDi>0768627CSTACC-854-9D</basicUdiDi>
    <tradeName>Norco Comfortprene Splinting Material</tradeName>
    <deviceName>Comfortprene Splinting Material</deviceName>
    <manufacturerName>North Coast Medical Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000009087</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>M030504</emdnCode>
    <emdnDescription>IMMOBILISATION SYSTEMS, MOULDABLE UNDER COLD AND HOT TEMPRATURES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NC68000</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:17:36.592Z</lastUpdated>
  </row>
  <row>
    <udiDi>00768627008792</udiDi>
    <basicUdiDi>0768627CSTACC-2690-T9</basicUdiDi>
    <tradeName>Omega Black Thermoplastic</tradeName>
    <deviceName>Omega Black Thermoplastic</deviceName>
    <manufacturerName>North Coast Medical Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000009087</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>M030504</emdnCode>
    <emdnDescription>IMMOBILISATION SYSTEMS, MOULDABLE UNDER COLD AND HOT TEMPRATURES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NC12796-1B</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:17:31.791Z</lastUpdated>
  </row>
  <row>
    <udiDi>00768627006477</udiDi>
    <basicUdiDi>0768627CSTACC-635-8Q</basicUdiDi>
    <tradeName>Preformed Functional Position Hand Splint 1/8"</tradeName>
    <deviceName>Preformed Functional Position Hand Splint 1/8"</deviceName>
    <manufacturerName>North Coast Medical Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000009087</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>M030504</emdnCode>
    <emdnDescription>IMMOBILISATION SYSTEMS, MOULDABLE UNDER COLD AND HOT TEMPRATURES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NC15920-D</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:17:13.382Z</lastUpdated>
  </row>
  <row>
    <udiDi>00768627002707</udiDi>
    <basicUdiDi>0768627CSTACC-1032-QU</basicUdiDi>
    <tradeName>Solaris</tradeName>
    <deviceName>Solaris</deviceName>
    <manufacturerName>North Coast Medical Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000009087</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>M030504</emdnCode>
    <emdnDescription>IMMOBILISATION SYSTEMS, MOULDABLE UNDER COLD AND HOT TEMPRATURES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NC14030-1</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:16:59.141Z</lastUpdated>
  </row>
  <row>
    <udiDi>00768627002639</udiDi>
    <basicUdiDi>0768627CSTACC-985-A6</basicUdiDi>
    <tradeName>Encore</tradeName>
    <deviceName>Encore</deviceName>
    <manufacturerName>North Coast Medical Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000009087</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>M030504</emdnCode>
    <emdnDescription>IMMOBILISATION SYSTEMS, MOULDABLE UNDER COLD AND HOT TEMPRATURES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NC14000-1</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:16:58.195Z</lastUpdated>
  </row>
  <row>
    <udiDi>00768627002608</udiDi>
    <basicUdiDi>0768627CSTACC-1038-RE</basicUdiDi>
    <tradeName>Omega Plus</tradeName>
    <deviceName>Omega Plus</deviceName>
    <manufacturerName>North Coast Medical Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000009087</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>M030504</emdnCode>
    <emdnDescription>IMMOBILISATION SYSTEMS, MOULDABLE UNDER COLD AND HOT TEMPRATURES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NC13310-1</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:16:54.200Z</lastUpdated>
  </row>
  <row>
    <udiDi>00768627002592</udiDi>
    <basicUdiDi>0768627CSTACC-1027-R6</basicUdiDi>
    <tradeName>Omega Max</tradeName>
    <deviceName>Omega Max</deviceName>
    <manufacturerName>North Coast Medical Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000009087</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>M030504</emdnCode>
    <emdnDescription>IMMOBILISATION SYSTEMS, MOULDABLE UNDER COLD AND HOT TEMPRATURES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NC13301-1</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:16:53.389Z</lastUpdated>
  </row>
  <row>
    <udiDi>00768627002400</udiDi>
    <basicUdiDi>0768627CSTACC-2386-SZ</basicUdiDi>
    <tradeName>Prism</tradeName>
    <deviceName>Prism</deviceName>
    <manufacturerName>North Coast Medical Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000009087</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>M030504</emdnCode>
    <emdnDescription>IMMOBILISATION SYSTEMS, MOULDABLE UNDER COLD AND HOT TEMPRATURES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NC12954-1</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:16:52.592Z</lastUpdated>
  </row>
  <row>
    <udiDi>00768627002318</udiDi>
    <basicUdiDi>0768627CSTACC-1006-QR</basicUdiDi>
    <tradeName>Vanilla</tradeName>
    <deviceName>Vanilla</deviceName>
    <manufacturerName>North Coast Medical Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000009087</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>M030504</emdnCode>
    <emdnDescription>IMMOBILISATION SYSTEMS, MOULDABLE UNDER COLD AND HOT TEMPRATURES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NC12924-1</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:16:51.819Z</lastUpdated>
  </row>
  <row>
    <udiDi>00768627002301</udiDi>
    <basicUdiDi>0768627CSTACC-1012-QJ</basicUdiDi>
    <tradeName>Spectrum</tradeName>
    <deviceName>Spectrum</deviceName>
    <manufacturerName>North Coast Medical Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000009087</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>M030504</emdnCode>
    <emdnDescription>IMMOBILISATION SYSTEMS, MOULDABLE UNDER COLD AND HOT TEMPRATURES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>https://www.ncmedical.com/products/spectrum_1012.html?objectID=1012&amp;queryID=867fa3ec90d2731568012a886f2e56dd</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:16:47.785Z</lastUpdated>
  </row>
  <row>
    <udiDi>00768627002189</udiDi>
    <basicUdiDi>0768627CSTACC-482-8S</basicUdiDi>
    <tradeName>Clinic</tradeName>
    <deviceName>Clinic</deviceName>
    <manufacturerName>North Coast Medical Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000009087</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>M030504</emdnCode>
    <emdnDescription>IMMOBILISATION SYSTEMS, MOULDABLE UNDER COLD AND HOT TEMPRATURES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NC12865-1</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:16:46.969Z</lastUpdated>
  </row>
  <row>
    <udiDi>B54180030000</udiDi>
    <basicUdiDi>++B5418003X3</basicUdiDi>
    <tradeName>Pelvic Binder Military</tradeName>
    <deviceName>Pelvic binder</deviceName>
    <manufacturerName>FareTec Inc</manufacturerName>
    <manufacturerSrn>US-MF-000014693</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>M030504</emdnCode>
    <emdnDescription>IMMOBILISATION SYSTEMS, MOULDABLE UNDER COLD AND HOT TEMPRATURES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8003000</reference>
    <placedOnMarketCountry>Slovakia</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:55:08.925Z</lastUpdated>
  </row>
  <row>
    <udiDi>B54112113050</udiDi>
    <basicUdiDi>++B5411211VT</basicUdiDi>
    <tradeName>Redi Universal Splint, Extra Small, Black, flat</tradeName>
    <deviceName>Redi Splint</deviceName>
    <manufacturerName>FareTec Inc</manufacturerName>
    <manufacturerSrn>US-MF-000014693</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>M030504</emdnCode>
    <emdnDescription>IMMOBILISATION SYSTEMS, MOULDABLE UNDER COLD AND HOT TEMPRATURES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1211305</reference>
    <placedOnMarketCountry>Slovakia</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:55:01.814Z</lastUpdated>
  </row>
  <row>
    <udiDi>03701422900493</udiDi>
    <basicUdiDi>37014229NOVASPINELM</basicUdiDi>
    <tradeName>NOVASPINE ST</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NOVATEX MEDICAL SA</manufacturerName>
    <manufacturerSrn>FR-MF-000014276</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>M030504</emdnCode>
    <emdnDescription>IMMOBILISATION SYSTEMS, MOULDABLE UNDER COLD AND HOT TEMPRATURES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>03701422900493</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-14T17:49:30.559Z</lastUpdated>
  </row>
</eudamedExport>