<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>04719964466277</udiDi>
    <basicUdiDi>47199644623WA</basicUdiDi>
    <tradeName>RPS T9 PRO</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>231109(S/UNI/Black)</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:48:19.194Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719964466284</udiDi>
    <basicUdiDi>47199644623WA</basicUdiDi>
    <tradeName>RPS T9 PRO</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>231109(M/UNI/Black)</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:48:12.537Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719964466291</udiDi>
    <basicUdiDi>47199644623WA</basicUdiDi>
    <tradeName>RPS T9 PRO</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>231109(L/UNI/Black)</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:48:12.515Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719964466307</udiDi>
    <basicUdiDi>47199644623WA</basicUdiDi>
    <tradeName>RPS T9 PRO</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>231109(XL/UNI/Black)</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:48:12.501Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719964466314</udiDi>
    <basicUdiDi>47199644623WA</basicUdiDi>
    <tradeName>RPS T9 PRO</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>231109(2XL/UNI/Black)</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:48:12.444Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719964463566</udiDi>
    <basicUdiDi>47199644651WF</basicUdiDi>
    <tradeName>Athena Thigh Support</tradeName>
    <deviceName></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></emdnCode>
    <emdnDescription>THIGH ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>512001(S/UNI/Blue)</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T21:34:26.328Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719964461845</udiDi>
    <basicUdiDi>47199644613W7</basicUdiDi>
    <tradeName>Minerva CTO</tradeName>
    <deviceName>Collar (Cervical Thoracic 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></emdnCode>
    <emdnDescription>CERVICOTHORACIC SPINE ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>130001(Universal/UNI/White)</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T21:34:25.624Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719964466376</udiDi>
    <basicUdiDi>47199644625WE</basicUdiDi>
    <tradeName>RPS S1 BELT</tradeName>
    <deviceName>Back Brace (Pelvic Support)</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></emdnCode>
    <emdnDescription>SACROILIAC SPINE ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>251101(Universal/UNI/Black)</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T21:34:23.942Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719964464853</udiDi>
    <basicUdiDi>47199644661WJ</basicUdiDi>
    <tradeName>Plantar Fasciitis Compression Sock</tradeName>
    <deviceName>Ankle Brace, Knee Brace (Calf Support)</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></emdnCode>
    <emdnDescription>PASSIVE ANKLE-FOOT ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>610002(XS/UNI/Black)</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T21:34:23.122Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719964461463</udiDi>
    <basicUdiDi>47199644665WS</basicUdiDi>
    <tradeName>Bunion Corrector</tradeName>
    <deviceName>Insole (Hallux valgus metatarsophalangeal orthosis and toe separator)</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></emdnCode>
    <emdnDescription>ORTHOSES, FOOT (INCLUDING INSOLES AND INSERTS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>650001(L/Left/Gray&amp;Silver)</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T21:34:09.567Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719964461234</udiDi>
    <basicUdiDi>47199644664WQ</basicUdiDi>
    <tradeName>Full Length Insole</tradeName>
    <deviceName>Insole (Orthotic insole)</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></emdnCode>
    <emdnDescription>ORTHOSES, FOOT (INCLUDING INSOLES AND INSERTS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>640001(L/UNI/White)</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T21:34:07.868Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719964460251</udiDi>
    <basicUdiDi>47199644662WL</basicUdiDi>
    <tradeName>AFO Splint</tradeName>
    <deviceName>Ankle Brace, Ankle Foot Orthosis, Night Splint (Ankle/foot 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></emdnCode>
    <emdnDescription>PASSIVE ANKLE-FOOT ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>620001(L/Left/White)</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-01T21:34:07.074Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719892939485</udiDi>
    <basicUdiDi>47199644663WN</basicUdiDi>
    <tradeName>Walking Boot</tradeName>
    <deviceName>Walking Boots (Ankle/foot 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></emdnCode>
    <emdnDescription>PASSIVE ANKLE-FOOT ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>635101(11L/UNI/Gray&amp;Silver)</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T21:32:55.788Z</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></emdnCode>
    <emdnDescription>WRIST (FOREARM) ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>418001(Universal/UNI/Black)</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T21:32:54.961Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719892936774</udiDi>
    <basicUdiDi>47199644631W9</basicUdiDi>
    <tradeName>Post-op Elbow Brace</tradeName>
    <deviceName>Elbow Brace, Post-OP Brace (Elbow 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></emdnCode>
    <emdnDescription>ELBOW ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>311001(Universal/Left/Black)</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-01T21:32:54.157Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719892936330</udiDi>
    <basicUdiDi>47199644626WG</basicUdiDi>
    <tradeName>Counter Hip Brace</tradeName>
    <deviceName>Post-OP Brace (Hip 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></emdnCode>
    <emdnDescription>HIP ORTHOSES (INCLUDING ABDUCTION ORTHOSES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>260001(L/Left/Black)</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T21:32:53.361Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719892936033</udiDi>
    <basicUdiDi>47199644624WC</basicUdiDi>
    <tradeName>Molded Body Jacket</tradeName>
    <deviceName>Back Brace (Thoracolumbar Support)</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></emdnCode>
    <emdnDescription>THORACOLUMBAR ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>240001(L/UNI/Gray&amp;Silver)</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T21:32:52.559Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719892935692</udiDi>
    <basicUdiDi>47199644623WA</basicUdiDi>
    <tradeName>Abdominal Binder</tradeName>
    <deviceName>Back Brace (Waist Support)</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></emdnCode>
    <emdnDescription>ABDOMINAL MUSCLES SUPPORTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>230001(L/UNI/Gray&amp;Silver)</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T21:32:51.753Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719892935357</udiDi>
    <basicUdiDi>47199644622W8</basicUdiDi>
    <tradeName>Posture Support Brace</tradeName>
    <deviceName>Posture Corrector (Clavicle 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></emdnCode>
    <emdnDescription>SHOULDER ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>220001(L/UNI/Gray&amp;Silver)</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T21:32:50.967Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719892934251</udiDi>
    <basicUdiDi>47199644652WH</basicUdiDi>
    <tradeName>DAILY OA KNEE BRACE</tradeName>
    <deviceName>Functional Knee Brace, Knee Brace, OA Knee Brace, Post-OP Brace (Knee support 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>Y061209</emdnCode>
    <emdnDescription>KNEE ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>525004(Universal/Left/Black)</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-01T21:32:50.149Z</lastUpdated>
  </row>
</eudamedExport>