<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>05025392704829</udiDi>
    <basicUdiDi>50253920000000000000006WC</basicUdiDi>
    <tradeName>Vulkan Elasticated Knee Support</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Performance Health International LTD</manufacturerName>
    <manufacturerSrn>GB-MF-000003319</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y06120601</emdnCode>
    <emdnDescription>PASSIVE ANKLE-FOOT ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>091237478</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T03:49:02.721Z</lastUpdated>
  </row>
  <row>
    <udiDi>05025392704843</udiDi>
    <basicUdiDi>50253920000000000000006WC</basicUdiDi>
    <tradeName>Vulkan Elasticated Knee Support</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Performance Health International LTD</manufacturerName>
    <manufacturerSrn>GB-MF-000003319</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y06120601</emdnCode>
    <emdnDescription>PASSIVE ANKLE-FOOT ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>091237494</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T03:49:02.631Z</lastUpdated>
  </row>
  <row>
    <udiDi>05025392709947</udiDi>
    <basicUdiDi>50253920000000000000006WC</basicUdiDi>
    <tradeName>Vulkan Athletic Support</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Performance Health International LTD</manufacturerName>
    <manufacturerSrn>GB-MF-000003319</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y06120601</emdnCode>
    <emdnDescription>PASSIVE ANKLE-FOOT ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>091252295</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T03:49:02.594Z</lastUpdated>
  </row>
  <row>
    <udiDi>05025392709930</udiDi>
    <basicUdiDi>50253920000000000000006WC</basicUdiDi>
    <tradeName>Vulkan Athletic Support</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Performance Health International LTD</manufacturerName>
    <manufacturerSrn>GB-MF-000003319</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y06120601</emdnCode>
    <emdnDescription>PASSIVE ANKLE-FOOT ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>091252303</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T03:49:02.535Z</lastUpdated>
  </row>
  <row>
    <udiDi>05025392709923</udiDi>
    <basicUdiDi>50253920000000000000006WC</basicUdiDi>
    <tradeName>Vulkan Athletic Support</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Performance Health International LTD</manufacturerName>
    <manufacturerSrn>GB-MF-000003319</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y06120601</emdnCode>
    <emdnDescription>PASSIVE ANKLE-FOOT ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>091252311</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T03:49:02.497Z</lastUpdated>
  </row>
  <row>
    <udiDi>05025392709916</udiDi>
    <basicUdiDi>50253920000000000000006WC</basicUdiDi>
    <tradeName>Vulkan Athletic Support</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Performance Health International LTD</manufacturerName>
    <manufacturerSrn>GB-MF-000003319</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y06120601</emdnCode>
    <emdnDescription>PASSIVE ANKLE-FOOT ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>091252329</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T03:49:02.427Z</lastUpdated>
  </row>
  <row>
    <udiDi>08715669003300</udiDi>
    <basicUdiDi>87156692201WJ</basicUdiDi>
    <tradeName>PUSH</tradeName>
    <deviceName>Push med Ankle Brace</deviceName>
    <manufacturerName>Nea International</manufacturerName>
    <manufacturerSrn>NL-MF-000006631</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y06120601</emdnCode>
    <emdnDescription>PASSIVE ANKLE-FOOT ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2.20.1.11</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:24:29.028Z</lastUpdated>
  </row>
  <row>
    <udiDi>08595571405689</udiDi>
    <basicUdiDi>85955714ORTEX06JQ4</basicUdiDi>
    <tradeName>ORTEX 06J Ortéza hlezenního kloubu rigidní – AIR WALKER</tradeName>
    <deviceName>ORTEX 06J Ortéza hlezenního kloubu rigidní – AIR WALKER</deviceName>
    <manufacturerName>ORTEX , spol. s r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000048500</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y06120601</emdnCode>
    <emdnDescription>PASSIVE ANKLE-FOOT ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N/A</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:24:09.814Z</lastUpdated>
  </row>
  <row>
    <udiDi>08595571404903</udiDi>
    <basicUdiDi>85955714ORTEX06HPY</basicUdiDi>
    <tradeName>ORTEX 06H Ortéza Achillovy šlachy</tradeName>
    <deviceName>ORTEX 06H Ortéza Achillovy šlachy</deviceName>
    <manufacturerName>ORTEX , spol. s r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000048500</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y06120601</emdnCode>
    <emdnDescription>PASSIVE ANKLE-FOOT ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N/A</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:24:09.036Z</lastUpdated>
  </row>
  <row>
    <udiDi>08595571404842</udiDi>
    <basicUdiDi>85955714ORTEX06CPN</basicUdiDi>
    <tradeName>ORTEX 06C Ortéza hlezenní zpevňující s křížovým tahem</tradeName>
    <deviceName>ORTEX 06C Ortéza hlezenní zpevňující s křížovým tahem</deviceName>
    <manufacturerName>ORTEX , spol. s r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000048500</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y06120601</emdnCode>
    <emdnDescription>PASSIVE ANKLE-FOOT ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N/A</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:24:08.214Z</lastUpdated>
  </row>
  <row>
    <udiDi>08595571404781</udiDi>
    <basicUdiDi>85955714ORTEX06APJ</basicUdiDi>
    <tradeName>ORTEX 06A Ortéza hlezenního kloubu fixační s třemi dlahami</tradeName>
    <deviceName>ORTEX 06A Ortéza hlezenního kloubu fixační s třemi dlahami</deviceName>
    <manufacturerName>ORTEX , spol. s r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000048500</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y06120601</emdnCode>
    <emdnDescription>PASSIVE ANKLE-FOOT ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N/A</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:24:04.206Z</lastUpdated>
  </row>
  <row>
    <udiDi>08595571403821</udiDi>
    <basicUdiDi>85955714ORTEX06GPW</basicUdiDi>
    <tradeName>ORTEX 06G Ortéza hlezenního kloubu stavitelná – Typ Walker</tradeName>
    <deviceName>ORTEX 06G Ortéza hlezenního kloubu stavitelná - typ Walker</deviceName>
    <manufacturerName>ORTEX , spol. s r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000048500</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y06120601</emdnCode>
    <emdnDescription>PASSIVE ANKLE-FOOT ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N/A</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:24:03.410Z</lastUpdated>
  </row>
  <row>
    <udiDi>08595571403692</udiDi>
    <basicUdiDi>85955714ORTEX06FPU</basicUdiDi>
    <tradeName>ORTEX 06F Ortéza hlezenního kloubu rigidní</tradeName>
    <deviceName>ORTEX 06F Ortéza hlezenního kloubu rigidní</deviceName>
    <manufacturerName>ORTEX , spol. s r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000048500</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y06120601</emdnCode>
    <emdnDescription>PASSIVE ANKLE-FOOT ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N/A</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:24:02.618Z</lastUpdated>
  </row>
  <row>
    <udiDi>08595571401438</udiDi>
    <basicUdiDi>85955714ORTEX06EPS</basicUdiDi>
    <tradeName>ORTEX 06E Bandáž hlezenního kloubu úpletová se silikonovou výztuhou</tradeName>
    <deviceName>ORTEX 06E Bandáž hlezenního kloubu úpletová se silikonovou výztuhou</deviceName>
    <manufacturerName>ORTEX , spol. s r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000048500</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y06120601</emdnCode>
    <emdnDescription>PASSIVE ANKLE-FOOT ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N/A</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:23:57.013Z</lastUpdated>
  </row>
  <row>
    <udiDi>08595571401421</udiDi>
    <basicUdiDi>85955714ORTEX06DPQ</basicUdiDi>
    <tradeName>ORTEX 06D Ortéza hlezenního kloubu</tradeName>
    <deviceName>ORTEX 06D Ortéza hlezenního kloubu</deviceName>
    <manufacturerName>ORTEX , spol. s r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000048500</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y06120601</emdnCode>
    <emdnDescription>PASSIVE ANKLE-FOOT ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N/A</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:23:56.209Z</lastUpdated>
  </row>
  <row>
    <udiDi>08056598553260</udiDi>
    <basicUdiDi>805659855DT305EE</basicUdiDi>
    <tradeName>PIN CAM WALKER EU026 MIS. S - CONF. DA 1 PZ</tradeName>
    <deviceName></deviceName>
    <manufacturerName>EUMEDICA SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000026164</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y06120601</emdnCode>
    <emdnDescription>PASSIVE ANKLE-FOOT ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EU026S</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:13:13.029Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810178393848</udiDi>
    <basicUdiDi>081004743AZP</basicUdiDi>
    <tradeName>SAMMONS PRESTON® LIGHTWEIGHT WALKER, SHORT, X-LARGE, INTL</tradeName>
    <deviceName>Walker / Foot-Ankle</deviceName>
    <manufacturerName>Ovation Medical</manufacturerName>
    <manufacturerSrn>US-MF-000051616</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y06120601</emdnCode>
    <emdnDescription>PASSIVE ANKLE-FOOT ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7038962</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-22T19:57:47.908Z</lastUpdated>
  </row>
  <row>
    <udiDi>00194545170837</udiDi>
    <basicUdiDi>194545DORSIANKLEBN</basicUdiDi>
    <tradeName>Model 32450A Service Kit</tradeName>
    <deviceName>Dorsi Assist Ankle Components</deviceName>
    <manufacturerName>Becker Orthopedic Appliance Company</manufacturerName>
    <manufacturerSrn>US-MF-000004002</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y06120601</emdnCode>
    <emdnDescription>PASSIVE ANKLE-FOOT ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>REFURB-AJ-005</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T19:57:33.504Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810178393978</udiDi>
    <basicUdiDi>081004743AZP</basicUdiDi>
    <tradeName>SAMMONS PRESTON® LIGHTWEIGHT PNEUMATIC WALKER, LARGE, INTL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ovation Medical</manufacturerName>
    <manufacturerSrn>US-MF-000051616</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y06120601</emdnCode>
    <emdnDescription>PASSIVE ANKLE-FOOT ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7038949</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-22T19:54:30.964Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810178393961</udiDi>
    <basicUdiDi>081004743AZP</basicUdiDi>
    <tradeName>SAMMONS PRESTON® LIGHTWEIGHT PNEUMATIC WALKER, X-LARGE, INTL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ovation Medical</manufacturerName>
    <manufacturerSrn>US-MF-000051616</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y06120601</emdnCode>
    <emdnDescription>PASSIVE ANKLE-FOOT ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7038950</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-22T19:54:30.493Z</lastUpdated>
  </row>
</eudamedExport>