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    <basicUdiDi>37014229NOVASPINELM</basicUdiDi>
    <tradeName>03701422907249</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>03701422907249</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-22T19:53:00.665Z</lastUpdated>
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  <row>
    <udiDi>03701422907256</udiDi>
    <basicUdiDi>37014229NOVASPINELM</basicUdiDi>
    <tradeName>03701422907256</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>03701422907256</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-22T19:52:59.489Z</lastUpdated>
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  <row>
    <udiDi>03701422907263</udiDi>
    <basicUdiDi>37014229NOVASPINELM</basicUdiDi>
    <tradeName>03701422907263</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>03701422907263</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-22T19:52:58.640Z</lastUpdated>
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  <row>
    <udiDi>03701459802470</udiDi>
    <basicUdiDi>B-03701459802470</basicUdiDi>
    <tradeName>AD THERMO</tradeName>
    <deviceName>AD THERMO</deviceName>
    <manufacturerName>GROUPE SOBER SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000017818</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>M030504</emdnCode>
    <emdnDescription>IMMOBILISATION SYSTEMS, MOULDABLE UNDER COLD AND HOT TEMPRATURES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AD THERMO</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:35:18.152Z</lastUpdated>
  </row>
  <row>
    <udiDi>03701459802463</udiDi>
    <basicUdiDi>B-03701459802463</basicUdiDi>
    <tradeName>AD THERMO</tradeName>
    <deviceName>AD THERMO</deviceName>
    <manufacturerName>GROUPE SOBER SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000017818</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>M030504</emdnCode>
    <emdnDescription>IMMOBILISATION SYSTEMS, MOULDABLE UNDER COLD AND HOT TEMPRATURES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AD THERMO</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:35:17.334Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697442359V3</udiDi>
    <basicUdiDi>B-697442359V3</basicUdiDi>
    <tradeName>D-697442359V3</tradeName>
    <deviceName>KK-IWN08</deviceName>
    <manufacturerName>Koolcare Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017687</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>M030504</emdnCode>
    <emdnDescription>IMMOBILISATION SYSTEMS, MOULDABLE UNDER COLD AND HOT TEMPRATURES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KK-IWN08</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:16:48.299Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697442359RPAUMT5</udiDi>
    <basicUdiDi>B-697442359RPAUMT5</basicUdiDi>
    <tradeName>D-697442359RPAUMT5</tradeName>
    <deviceName>Cold/Hot Pack</deviceName>
    <manufacturerName>Koolcare Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017687</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>M030504</emdnCode>
    <emdnDescription>IMMOBILISATION SYSTEMS, MOULDABLE UNDER COLD AND HOT TEMPRATURES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KK-RP-A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:16:43.183Z</lastUpdated>
  </row>
  <row>
    <udiDi>03701459808083</udiDi>
    <basicUdiDi>B-03701459808083</basicUdiDi>
    <tradeName>APB THERMO PLUS</tradeName>
    <deviceName>APB THERMO PLUS</deviceName>
    <manufacturerName>GROUPE SOBER SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000017818</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>M030504</emdnCode>
    <emdnDescription>IMMOBILISATION SYSTEMS, MOULDABLE UNDER COLD AND HOT TEMPRATURES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>APB THERMO PLUS</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:49:26.045Z</lastUpdated>
  </row>
  <row>
    <udiDi>03701459808076</udiDi>
    <basicUdiDi>B-03701459808076</basicUdiDi>
    <tradeName>APB THERMO PLUS</tradeName>
    <deviceName>APB THERMO PLUS</deviceName>
    <manufacturerName>GROUPE SOBER SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000017818</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>M030504</emdnCode>
    <emdnDescription>IMMOBILISATION SYSTEMS, MOULDABLE UNDER COLD AND HOT TEMPRATURES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>APB THERMO PLUS</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:49:25.247Z</lastUpdated>
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  <row>
    <udiDi>03701459808090</udiDi>
    <basicUdiDi>B-03701459808090</basicUdiDi>
    <tradeName>APB THERMO PLUS</tradeName>
    <deviceName>APB THERMO PLUS</deviceName>
    <manufacturerName>GROUPE SOBER SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000017818</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>M030504</emdnCode>
    <emdnDescription>IMMOBILISATION SYSTEMS, MOULDABLE UNDER COLD AND HOT TEMPRATURES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>APB THERMO PLUS</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:49:23.734Z</lastUpdated>
  </row>
  <row>
    <udiDi>03701459808069</udiDi>
    <basicUdiDi>B-03701459808069</basicUdiDi>
    <tradeName>APB THERMO PLUS</tradeName>
    <deviceName>APB THERMO PLUS</deviceName>
    <manufacturerName>GROUPE SOBER SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000017818</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>M030504</emdnCode>
    <emdnDescription>IMMOBILISATION SYSTEMS, MOULDABLE UNDER COLD AND HOT TEMPRATURES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>APB THERMO PLUS</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:49:06.777Z</lastUpdated>
  </row>
  <row>
    <udiDi>08717973156987</udiDi>
    <basicUdiDi>871797315LTTP-007OTHN</basicUdiDi>
    <tradeName>S-Cast (NS)</tradeName>
    <deviceName>S cast</deviceName>
    <manufacturerName>Ttape Company</manufacturerName>
    <manufacturerSrn>NL-MF-000003944</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>STNS54S3207</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T09:39:21.423Z</lastUpdated>
  </row>
  <row>
    <udiDi>05690977838550</udiDi>
    <basicUdiDi>5690967BU00113N7</basicUdiDi>
    <tradeName>Ucast</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Össur Iceland ehf.</manufacturerName>
    <manufacturerSrn>IS-MF-000000173</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>A-WRIST-L</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T07:05:32.784Z</lastUpdated>
  </row>
  <row>
    <udiDi>05425025430185</udiDi>
    <basicUdiDi>542502543fractomedS4</basicUdiDi>
    <tradeName>Fractomed</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Mondomed NV</manufacturerName>
    <manufacturerSrn>BE-MF-000001283</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>1044745</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-16T06:59:35.081Z</lastUpdated>
  </row>
  <row>
    <udiDi>00768627127905</udiDi>
    <basicUdiDi>0768627CSTACC-1002-QD</basicUdiDi>
    <tradeName>Preferred</tradeName>
    <deviceName>Preferred</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>NC12790</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:19:11.981Z</lastUpdated>
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  <row>
    <udiDi>00768627015318</udiDi>
    <basicUdiDi>0768627CSTACC-1650-SA</basicUdiDi>
    <tradeName>Base 2 Outrigger Starter Kit</tradeName>
    <deviceName>Base 2 Outrigger Starter 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>NC12840</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:18:34.294Z</lastUpdated>
  </row>
  <row>
    <udiDi>00768627015295</udiDi>
    <basicUdiDi>0768627CSTACC-681-95</basicUdiDi>
    <tradeName>Base 2 Single Finger Extension Kit</tradeName>
    <deviceName>Base 2 Single Finger Extension 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>NC12820</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:18:31.877Z</lastUpdated>
  </row>
  <row>
    <udiDi>00768627015288</udiDi>
    <basicUdiDi>0768627CSTACC-1647-SS</basicUdiDi>
    <tradeName>Base 2 Multi-Digit MP Extension Kit</tradeName>
    <deviceName>Base 2 Multi-Digit MP Extension 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>NC12821</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:18:29.832Z</lastUpdated>
  </row>
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    <udiDi>00768627015271</udiDi>
    <basicUdiDi>0768627CSTACC-690-97</basicUdiDi>
    <tradeName>Phoenix Slotted Pulleys</tradeName>
    <deviceName>Phoenix Slotted Pulleys</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>NC12760-1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:18:27.897Z</lastUpdated>
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  <row>
    <udiDi>00768627015264</udiDi>
    <basicUdiDi>0768627CSTACC-695-9N</basicUdiDi>
    <tradeName>Phoenix Extended Outrigger Kit</tradeName>
    <deviceName>Phoenix Extended 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>NC12763</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:18:27.135Z</lastUpdated>
  </row>
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