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    <tradeName>SAM® Splint</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SAM Medical Products</manufacturerName>
    <manufacturerSrn>US-MF-000002589</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>M03050202</emdnCode>
    <emdnDescription>SYNTHETIC CAST BANDAGES AND SPLINTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SP500-CH-EN</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:04:14.836Z</lastUpdated>
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    <udiDi>00822045428904</udiDi>
    <basicUdiDi>0822045SP01US</basicUdiDi>
    <tradeName>SAM® Splint XL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SAM Medical Products</manufacturerName>
    <manufacturerSrn>US-MF-000002589</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>M03050202</emdnCode>
    <emdnDescription>SYNTHETIC CAST BANDAGES AND SPLINTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SP508-CH-EN</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:04:14.819Z</lastUpdated>
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    <udiDi>00822045428928</udiDi>
    <basicUdiDi>0822045SP01US</basicUdiDi>
    <tradeName>SAM® Splint [EN]</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SAM Medical Products</manufacturerName>
    <manufacturerSrn>US-MF-000002589</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>M03050202</emdnCode>
    <emdnDescription>SYNTHETIC CAST BANDAGES AND SPLINTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SP502-CH-EN</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:04:14.785Z</lastUpdated>
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    <tradeName>UNO</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Dassiet Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000016466</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>M03050202</emdnCode>
    <emdnDescription>SYNTHETIC CAST BANDAGES AND SPLINTS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>U-EMS3</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-23T07:36:56.936Z</lastUpdated>
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    <udiDi>06430053264236</udiDi>
    <basicUdiDi>6430053260105U</basicUdiDi>
    <tradeName>UNO</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Dassiet Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000016466</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>M03050202</emdnCode>
    <emdnDescription>SYNTHETIC CAST BANDAGES AND SPLINTS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>U-EMS1</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-23T07:36:55.725Z</lastUpdated>
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    <udiDi>06430053264229</udiDi>
    <basicUdiDi>6430053260105U</basicUdiDi>
    <tradeName>UNO</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Dassiet Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000016466</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>M03050202</emdnCode>
    <emdnDescription>SYNTHETIC CAST BANDAGES AND SPLINTS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>U-TACT3</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-23T07:36:54.524Z</lastUpdated>
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  <row>
    <udiDi>08437021314755</udiDi>
    <basicUdiDi>8437021314serieFERULAAA</basicUdiDi>
    <tradeName>FÉRULAS DE TRACCIÓN ADULTO</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Productos metálicos del Bages (Promeba)</manufacturerName>
    <manufacturerSrn>ES-MF-000001922</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>M03050202</emdnCode>
    <emdnDescription>SYNTHETIC CAST BANDAGES AND SPLINTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PA-161</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T07:35:43.175Z</lastUpdated>
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  <row>
    <udiDi>08437021314762</udiDi>
    <basicUdiDi>8437021314serieFERULAAA</basicUdiDi>
    <tradeName>FÉRULA DE TRACCIÓN PEDIÁTRICA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Productos metálicos del Bages (Promeba)</manufacturerName>
    <manufacturerSrn>ES-MF-000001922</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>M03050202</emdnCode>
    <emdnDescription>SYNTHETIC CAST BANDAGES AND SPLINTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PA-164</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T07:35:43.160Z</lastUpdated>
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  <row>
    <udiDi>08437021314779</udiDi>
    <basicUdiDi>8437021314serieFERULAAA</basicUdiDi>
    <tradeName>KIT DE 5 FERULAS DE NEOPRENO</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Productos metálicos del Bages (Promeba)</manufacturerName>
    <manufacturerSrn>ES-MF-000001922</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>M03050202</emdnCode>
    <emdnDescription>SYNTHETIC CAST BANDAGES AND SPLINTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PA-47</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T07:35:43.150Z</lastUpdated>
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    <udiDi>08437021314786</udiDi>
    <basicUdiDi>8437021314serieFERULAAA</basicUdiDi>
    <tradeName>JUEGO DE 6 FÉRULAS UNIVERSAL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Productos metálicos del Bages (Promeba)</manufacturerName>
    <manufacturerSrn>ES-MF-000001922</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>M03050202</emdnCode>
    <emdnDescription>SYNTHETIC CAST BANDAGES AND SPLINTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PA-48</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T07:35:43.131Z</lastUpdated>
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  <row>
    <udiDi>08437021314793</udiDi>
    <basicUdiDi>8437021314serieFERULAAA</basicUdiDi>
    <tradeName>FÉRULAS DE VACÍO</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Productos metálicos del Bages (Promeba)</manufacturerName>
    <manufacturerSrn>ES-MF-000001922</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>M03050202</emdnCode>
    <emdnDescription>SYNTHETIC CAST BANDAGES AND SPLINTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PA-137</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T07:35:43.113Z</lastUpdated>
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  <row>
    <udiDi>08437021314809</udiDi>
    <basicUdiDi>8437021314serieFERULAAA</basicUdiDi>
    <tradeName>JUEGO DE FERULAS DE VACIO CON BOMBA PA-49</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Productos metálicos del Bages (Promeba)</manufacturerName>
    <manufacturerSrn>ES-MF-000001922</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>M03050202</emdnCode>
    <emdnDescription>SYNTHETIC CAST BANDAGES AND SPLINTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PA-49</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T07:35:43.093Z</lastUpdated>
  </row>
  <row>
    <udiDi>08437021314823</udiDi>
    <basicUdiDi>8437021314serieFERULAAA</basicUdiDi>
    <tradeName>JUEGO DE 3 FÉRULAS DE VACÍO CON BOMBA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Productos metálicos del Bages (Promeba)</manufacturerName>
    <manufacturerSrn>ES-MF-000001922</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>M03050202</emdnCode>
    <emdnDescription>SYNTHETIC CAST BANDAGES AND SPLINTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PA-186</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T07:35:43.066Z</lastUpdated>
  </row>
  <row>
    <udiDi>04042809013931</udiDi>
    <basicUdiDi>4042809400348879Z</basicUdiDi>
    <tradeName>Dynacast® Prelude</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BSN Medical Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000019174</manufacturerSrn>
    <authorisedRepresentativeName>BSN medical GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005791</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>M03050202</emdnCode>
    <emdnDescription>SYNTHETIC CAST BANDAGES AND SPLINTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>47222-00</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T22:38:01.934Z</lastUpdated>
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  <row>
    <udiDi>04042809013962</udiDi>
    <basicUdiDi>4042809400348879Z</basicUdiDi>
    <tradeName>Dynacast® Prelude</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BSN Medical Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000019174</manufacturerSrn>
    <authorisedRepresentativeName>BSN medical GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005791</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>M03050202</emdnCode>
    <emdnDescription>SYNTHETIC CAST BANDAGES AND SPLINTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>47224-00</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T22:38:01.905Z</lastUpdated>
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    <udiDi>04042809013993</udiDi>
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    <tradeName>Dynacast® Prelude</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BSN Medical Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000019174</manufacturerSrn>
    <authorisedRepresentativeName>BSN medical GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005791</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>M03050202</emdnCode>
    <emdnDescription>SYNTHETIC CAST BANDAGES AND SPLINTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>47225-00</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T22:38:01.883Z</lastUpdated>
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    <udiDi>04042809014020</udiDi>
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    <tradeName>Dynacast® Prelude</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BSN Medical Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000019174</manufacturerSrn>
    <authorisedRepresentativeName>BSN medical GmbH</authorisedRepresentativeName>
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    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>M03050202</emdnCode>
    <emdnDescription>SYNTHETIC CAST BANDAGES AND SPLINTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>47226-00</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T22:38:01.862Z</lastUpdated>
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    <udiDi>04042809014051</udiDi>
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    <tradeName>Dynacast® Prelude</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BSN Medical Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000019174</manufacturerSrn>
    <authorisedRepresentativeName>BSN medical GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005791</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>M03050202</emdnCode>
    <emdnDescription>SYNTHETIC CAST BANDAGES AND SPLINTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>47227-00</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T22:38:01.840Z</lastUpdated>
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    <udiDi>04042809014082</udiDi>
    <basicUdiDi>4042809400348879Z</basicUdiDi>
    <tradeName>Dynacast® Prelude</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BSN Medical Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000019174</manufacturerSrn>
    <authorisedRepresentativeName>BSN medical GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005791</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>M03050202</emdnCode>
    <emdnDescription>SYNTHETIC CAST BANDAGES AND SPLINTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>47235-00</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T22:38:01.813Z</lastUpdated>
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    <udiDi>04042809014822</udiDi>
    <basicUdiDi>4042809400352398X</basicUdiDi>
    <tradeName>Delta-Cast® Soft</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BSN Medical Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000019174</manufacturerSrn>
    <authorisedRepresentativeName>BSN medical GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005791</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>M03050202</emdnCode>
    <emdnDescription>SYNTHETIC CAST BANDAGES AND SPLINTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>72708-51</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T22:38:01.764Z</lastUpdated>
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