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<eudamedExport entity="devices">
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    <udiDi>05060982421458</udiDi>
    <basicUdiDi>506098242PNE0056Y</basicUdiDi>
    <tradeName>Neoprene Easy Wrist (UNI)</tradeName>
    <deviceName>PREMIA® NEOPRENE EASY WRIST (UNI)</deviceName>
    <manufacturerName>Fima Global Brands Ltd</manufacturerName>
    <manufacturerSrn>UK-MF-000036604</manufacturerSrn>
    <authorisedRepresentativeName>GLORY-Cosmetic Hungary Kft.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>HU-AR-000035374</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y060609</emdnCode>
    <emdnDescription>WRIST (FOREARM) ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PNE005</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-31T06:02:12.838Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060982421106</udiDi>
    <basicUdiDi>506098242PEW0047R</basicUdiDi>
    <tradeName>Elastic Wrist Wrap (UNI)</tradeName>
    <deviceName>PREMIA – ELASTIC WRIST WRAP (UNI)</deviceName>
    <manufacturerName>Fima Global Brands Ltd</manufacturerName>
    <manufacturerSrn>UK-MF-000036604</manufacturerSrn>
    <authorisedRepresentativeName>GLORY-Cosmetic Hungary Kft.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>HU-AR-000035374</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y060609</emdnCode>
    <emdnDescription>WRIST (FOREARM) ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PEW004</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-31T06:01:53.616Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060982420932</udiDi>
    <basicUdiDi>506098242P0R005-007HJ</basicUdiDi>
    <tradeName>Wrist Splint (S)</tradeName>
    <deviceName>PREMIA – WRIST SPLINT</deviceName>
    <manufacturerName>Fima Global Brands Ltd</manufacturerName>
    <manufacturerSrn>UK-MF-000036604</manufacturerSrn>
    <authorisedRepresentativeName>GLORY-Cosmetic Hungary Kft.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>HU-AR-000035374</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y060609</emdnCode>
    <emdnDescription>WRIST (FOREARM) ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>POR005</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-31T06:01:48.188Z</lastUpdated>
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  <row>
    <udiDi>05060982420482</udiDi>
    <basicUdiDi>506098242PNP0049B</basicUdiDi>
    <tradeName>MAGNETIC TOURMALINE WRIST ( UNI)</tradeName>
    <deviceName>Magnetic Tourmaline Wrist ( UNI)</deviceName>
    <manufacturerName>Fima Global Brands Ltd</manufacturerName>
    <manufacturerSrn>UK-MF-000036604</manufacturerSrn>
    <authorisedRepresentativeName>GLORY-Cosmetic Hungary Kft.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>HU-AR-000035374</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y060609</emdnCode>
    <emdnDescription>WRIST (FOREARM) ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PNP004</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-31T06:01:27.205Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060982420352</udiDi>
    <basicUdiDi>506098242PE013-0163M</basicUdiDi>
    <tradeName>ELASTICATED WRIST SUPPORT</tradeName>
    <deviceName>ELASTICATED WRIST SUPPORT</deviceName>
    <manufacturerName>Fima Global Brands Ltd</manufacturerName>
    <manufacturerSrn>UK-MF-000036604</manufacturerSrn>
    <authorisedRepresentativeName>GLORY-Cosmetic Hungary Kft.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>HU-AR-000035374</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y060609</emdnCode>
    <emdnDescription>WRIST (FOREARM) ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PE013</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-31T06:01:20.000Z</lastUpdated>
  </row>
  <row>
    <udiDi>05031720032939</udiDi>
    <basicUdiDi>5031720FT14WSEM</basicUdiDi>
    <tradeName>FORTUNA</tradeName>
    <deviceName>FEMALE ELASTICATED WRIST SUPPORT</deviceName>
    <manufacturerName>Fortuna Healthcare Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000048072</manufacturerSrn>
    <authorisedRepresentativeName>Fortuna Healthcare (Ireland) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000044547</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y060609</emdnCode>
    <emdnDescription>WRIST (FOREARM) ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FT1471</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:55:44.788Z</lastUpdated>
  </row>
  <row>
    <udiDi>05031720010012</udiDi>
    <basicUdiDi>5031720FT902WCM</basicUdiDi>
    <tradeName>FORTUNA</tradeName>
    <deviceName>FORTUNA ELASTICATED WRIST SUPPORT</deviceName>
    <manufacturerName>Fortuna Healthcare Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000048072</manufacturerSrn>
    <authorisedRepresentativeName>Fortuna Healthcare (Ireland) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000044547</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y060609</emdnCode>
    <emdnDescription>WRIST (FOREARM) ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FT902S</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:55:11.908Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719892937153</udiDi>
    <basicUdiDi>47199644641WC</basicUdiDi>
    <tradeName>Wristlet Brace</tradeName>
    <deviceName>Wrist Splint (Wrist orthosis)</deviceName>
    <manufacturerName>Orthotech Rehabilitation Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000051924</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y060609</emdnCode>
    <emdnDescription>WRIST (FOREARM) ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>418001(Universal/UNI/Black)</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:51:46.602Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719872862406</udiDi>
    <basicUdiDi>47198728641WE</basicUdiDi>
    <tradeName>Universal Wrist Brace</tradeName>
    <deviceName>Wrist Splint (Wrist orthosis)</deviceName>
    <manufacturerName>Zhangpu Ortholife Rehabilitation Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011447</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y060609</emdnCode>
    <emdnDescription>WRIST (FOREARM) ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>410001(Universal/UNI/Gray&amp;Silver)</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:44:47.267Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719872862390</udiDi>
    <basicUdiDi>47198728641WE</basicUdiDi>
    <tradeName>Wristlet Brace</tradeName>
    <deviceName>Wrist Splint (Wrist orthosis)</deviceName>
    <manufacturerName>Zhangpu Ortholife Rehabilitation Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011447</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y060609</emdnCode>
    <emdnDescription>WRIST (FOREARM) ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>418001(Universal/UNI/Black)</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:36:50.866Z</lastUpdated>
  </row>
  <row>
    <udiDi>04712931627954</udiDi>
    <basicUdiDi>471293162002A3</basicUdiDi>
    <tradeName>04712931627954</tradeName>
    <deviceName>Wrist Sleeve</deviceName>
    <manufacturerName>Rich Joy Co., Ltd.</manufacturerName>
    <manufacturerSrn>TW-MF-000012013</manufacturerSrn>
    <authorisedRepresentativeName>KOMAS Medical Technology GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000045617</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y060609</emdnCode>
    <emdnDescription>WRIST (FOREARM) ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PU-5101SM</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:29:07.369Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250239410408</udiDi>
    <basicUdiDi>42502394TSM113EA</basicUdiDi>
    <tradeName>TSM forearm sleeve active</tradeName>
    <deviceName>TSM wrist support strap active</deviceName>
    <manufacturerName>AET Australasian European Trading GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000009115</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y060609</emdnCode>
    <emdnDescription>WRIST (FOREARM) ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2111</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T20:54:56.653Z</lastUpdated>
  </row>
  <row>
    <udiDi>04035459015806</udiDi>
    <basicUdiDi>4035459DE0403A3A</basicUdiDi>
    <tradeName>04035459015806</tradeName>
    <deviceName>ORTHOFLEX KURZ</deviceName>
    <manufacturerName>Thuasne Deutschland GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006210</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y060609</emdnCode>
    <emdnDescription>WRIST (FOREARM) ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>T49300120401302</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T19:27:31.162Z</lastUpdated>
  </row>
  <row>
    <udiDi>08055776653860</udiDi>
    <basicUdiDi>805577665IMMOBILIZZMANOMM</basicUdiDi>
    <tradeName>CUSCINO IMBOTTITO NEVADA MIS. NEONATALE 1</tradeName>
    <deviceName>IMMOBILIZZATORI DELLA MANO E DEL POLSO</deviceName>
    <manufacturerName>ARTSANITY SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000031338</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y060609</emdnCode>
    <emdnDescription>WRIST (FOREARM) ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PRIME 1</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-29T08:35:57.681Z</lastUpdated>
  </row>
  <row>
    <udiDi>08055776653853</udiDi>
    <basicUdiDi>805577665IMMOBILIZZMANOMM</basicUdiDi>
    <tradeName>CUSCINO IMBOTTITO NEVADA MIS. XS(GR)</tradeName>
    <deviceName>IMMOBILIZZATORI DELLA MANO E DEL POLSO</deviceName>
    <manufacturerName>ARTSANITY SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000031338</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y060609</emdnCode>
    <emdnDescription>WRIST (FOREARM) ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>www.artsanity.it</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-29T08:34:02.155Z</lastUpdated>
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    <udiDi>08055776653815</udiDi>
    <basicUdiDi>805577665IMMOBILIZZMANOMM</basicUdiDi>
    <tradeName>CUSCINO IMBOTTITO NEVADA MIS. S(GR)</tradeName>
    <deviceName>IMMOBILIZZATORI DELLA MANO E DEL POLSO</deviceName>
    <manufacturerName>ARTSANITY SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000031338</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y060609</emdnCode>
    <emdnDescription>WRIST (FOREARM) ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NEVADA S G</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-29T08:32:01.421Z</lastUpdated>
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    <udiDi>08055776653785</udiDi>
    <basicUdiDi>805577665IMMOBILIZZMANOMM</basicUdiDi>
    <tradeName>CUSCINO IMBOTTITO NEVADA MIS. M(GR)</tradeName>
    <deviceName>IMMOBILIZZATORI DELLA MANO E DEL POLSO</deviceName>
    <manufacturerName>ARTSANITY SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000031338</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y060609</emdnCode>
    <emdnDescription>WRIST (FOREARM) ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NEVADA M G</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-29T08:30:08.236Z</lastUpdated>
  </row>
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    <udiDi>08055776653761</udiDi>
    <basicUdiDi>805577665IMMOBILIZZMANOMM</basicUdiDi>
    <tradeName>CUSCINO IMBOTTITO NEVADA MIS. L(GR)</tradeName>
    <deviceName>IMMOBILIZZATORI DELLA MANO E DEL POLSO</deviceName>
    <manufacturerName>ARTSANITY SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000031338</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y060609</emdnCode>
    <emdnDescription>WRIST (FOREARM) ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NEVADA L G</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-29T08:28:31.309Z</lastUpdated>
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    <udiDi>08055776653549</udiDi>
    <basicUdiDi>805577665IMMOBILIZZMANOMM</basicUdiDi>
    <tradeName>CUSCINO IMBOTTITO NEVADA MIS.NEONATALE 2</tradeName>
    <deviceName>IMMOBILIZZATORI DELLA MANO E DEL POLSO</deviceName>
    <manufacturerName>ARTSANITY SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000031338</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y060609</emdnCode>
    <emdnDescription>WRIST (FOREARM) ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PRIME 2</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-29T06:46:25.943Z</lastUpdated>
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    <udiDi>05901571485980</udiDi>
    <basicUdiDi>59015714AT531184K</basicUdiDi>
    <tradeName>Orteza nadgarstka</tradeName>
    <deviceName>ORTEZA NADGARSTKA</deviceName>
    <manufacturerName>ANTAR MEDICAL SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ</manufacturerName>
    <manufacturerSrn>PL-MF-000001583</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y060609</emdnCode>
    <emdnDescription>WRIST (FOREARM) ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AT53118</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-29T06:36:20.479Z</lastUpdated>
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