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<eudamedExport entity="devices">
  <row>
    <udiDi>00768627795302</udiDi>
    <basicUdiDi>0768627ORTHO-1260-MX</basicUdiDi>
    <tradeName>Comfort Cool Mid Thumb Spica Orthosis, S/M</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>WRIST-HAND-FINGERS ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NC79530</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:33:54.611Z</lastUpdated>
  </row>
  <row>
    <udiDi>00768627795319</udiDi>
    <basicUdiDi>0768627ORTHO-1260-MX</basicUdiDi>
    <tradeName>Comfort Cool Mid Thumb Spica Orthosis, L/XL</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>WRIST-HAND-FINGERS ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NC79531</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:33:54.594Z</lastUpdated>
  </row>
  <row>
    <udiDi>00768627795326</udiDi>
    <basicUdiDi>0768627ORTHO-1260-MX</basicUdiDi>
    <tradeName>Comfort Cool Long Thumb Spica Orthosis, S/M</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>WRIST-HAND-FINGERS ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NC79532</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:33:54.577Z</lastUpdated>
  </row>
  <row>
    <udiDi>00768627795333</udiDi>
    <basicUdiDi>0768627ORTHO-1260-MX</basicUdiDi>
    <tradeName>Comfort Cool Long Thumb Spica Orthosis L/XL</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>WRIST-HAND-FINGERS ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NC79533</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:33:54.562Z</lastUpdated>
  </row>
  <row>
    <udiDi>00768627795401</udiDi>
    <basicUdiDi>0768627ORTHO-63-R6</basicUdiDi>
    <tradeName>Comfort Cool Open Elbow Support</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ELBOW-WRIST ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NC79540</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:33:54.550Z</lastUpdated>
  </row>
  <row>
    <udiDi>00768627795418</udiDi>
    <basicUdiDi>0768627ORTHO-63-R6</basicUdiDi>
    <tradeName>Comfort Cool Open Elbow Support</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ELBOW-WRIST ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NC79541</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:33:54.538Z</lastUpdated>
  </row>
  <row>
    <udiDi>00768627795425</udiDi>
    <basicUdiDi>0768627ORTHO-63-R6</basicUdiDi>
    <tradeName>Comfort Cool Open Elbow Support</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ELBOW-WRIST ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NC79542</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:33:54.522Z</lastUpdated>
  </row>
  <row>
    <udiDi>00768627795432</udiDi>
    <basicUdiDi>0768627ORTHO-63-R6</basicUdiDi>
    <tradeName>Comfort Cool Open Elbow Support</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ELBOW-WRIST ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NC79543</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:33:54.511Z</lastUpdated>
  </row>
  <row>
    <udiDi>00768627795463</udiDi>
    <basicUdiDi>0768627ORTHO-77-RP</basicUdiDi>
    <tradeName>Comfort Cool Thumb CMC Restriction Splint L, XX-Small</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>WRIST-HAND-FINGERS ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NC79546</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:33:54.499Z</lastUpdated>
  </row>
  <row>
    <udiDi>00768627795470</udiDi>
    <basicUdiDi>0768627ORTHO-77-RP</basicUdiDi>
    <tradeName>Comfort Cool Thumb CMC Restriction Splint, R, XX-Smal</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>WRIST-HAND-FINGERS ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NC79547</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:33:54.485Z</lastUpdated>
  </row>
  <row>
    <udiDi>00768627795487</udiDi>
    <basicUdiDi>0768627ORTHO-77-RP</basicUdiDi>
    <tradeName>Comfort Cool Thumb CMC Restriction Splint, L X-Small</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>WRIST-HAND-FINGERS ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NC79548</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:33:54.468Z</lastUpdated>
  </row>
  <row>
    <udiDi>00768627795494</udiDi>
    <basicUdiDi>0768627ORTHO-77-RP</basicUdiDi>
    <tradeName>Comfort Cool Thumb CMC Restriction Splint</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>WRIST-HAND-FINGERS ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NC79549</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:33:54.451Z</lastUpdated>
  </row>
  <row>
    <udiDi>00768627795500</udiDi>
    <basicUdiDi>0768627ORTHO-77-RP</basicUdiDi>
    <tradeName>Comfort Cool Thumb CMC Restriction Splint, L XL</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>WRIST-HAND-FINGERS ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NC79550</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:33:54.432Z</lastUpdated>
  </row>
  <row>
    <udiDi>00768627795517</udiDi>
    <basicUdiDi>0768627ORTHO-77-RP</basicUdiDi>
    <tradeName>Comfort Cool Thumb CMC Restriction Splint, R XL</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>WRIST-HAND-FINGERS ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NC79551</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:33:54.416Z</lastUpdated>
  </row>
  <row>
    <udiDi>00768627795562</udiDi>
    <basicUdiDi>0768627ORTHO-77-RP</basicUdiDi>
    <tradeName>Comfort Cool Thumb CMC Restriction Splint, LS+</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>WRIST-HAND-FINGERS ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NC79556</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:33:54.402Z</lastUpdated>
  </row>
  <row>
    <udiDi>00768627795579</udiDi>
    <basicUdiDi>0768627ORTHO-77-RP</basicUdiDi>
    <tradeName>Comfort Cool Thumb CMC Restriction Splint, RS+</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>WRIST-HAND-FINGERS ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NC79557</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:33:54.388Z</lastUpdated>
  </row>
  <row>
    <udiDi>00768627795586</udiDi>
    <basicUdiDi>0768627ORTHO-77-RP</basicUdiDi>
    <tradeName>Comfort Cool Thumb CMC Restriction Splint, LM+</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>WRIST-HAND-FINGERS ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NC79558</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:33:54.372Z</lastUpdated>
  </row>
  <row>
    <udiDi>00768627795593</udiDi>
    <basicUdiDi>0768627ORTHO-77-RP</basicUdiDi>
    <tradeName>Comfort Cool Thumb CMC Restriction Splint, RM+</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>WRIST-HAND-FINGERS ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NC79559</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:33:54.352Z</lastUpdated>
  </row>
  <row>
    <udiDi>00768627795609</udiDi>
    <basicUdiDi>0768627ORTHO-77-RP</basicUdiDi>
    <tradeName>Comfort Cool Thumb CMC Restriction Splint, LL+</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>WRIST-HAND-FINGERS ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NC79560</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:33:54.332Z</lastUpdated>
  </row>
  <row>
    <udiDi>00768627795616</udiDi>
    <basicUdiDi>0768627ORTHO-77-RP</basicUdiDi>
    <tradeName>Comfort Cool Thumb CMC Restriction Splint, RL+</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>WRIST-HAND-FINGERS ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NC79561</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:33:54.308Z</lastUpdated>
  </row>
</eudamedExport>