<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>05060639240777</udiDi>
    <basicUdiDi>506063924GripsterM4</basicUdiDi>
    <tradeName>Gripster</tradeName>
    <deviceName>Gripster</deviceName>
    <manufacturerName>Open Bionics Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000032650</manufacturerSrn>
    <authorisedRepresentativeName>European Healthcare &amp; Device Solutions Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003999</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y060680</emdnCode>
    <emdnDescription>UPPER LIMB ORTHOSES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>300074</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:29:40.448Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060639240760</udiDi>
    <basicUdiDi>506063924RiderPS</basicUdiDi>
    <tradeName>Rider</tradeName>
    <deviceName>Rider</deviceName>
    <manufacturerName>Open Bionics Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000032650</manufacturerSrn>
    <authorisedRepresentativeName>European Healthcare &amp; Device Solutions Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003999</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y060680</emdnCode>
    <emdnDescription>UPPER LIMB ORTHOSES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>300073</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:29:39.684Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060639240753</udiDi>
    <basicUdiDi>506063924PranaQD</basicUdiDi>
    <tradeName>Prana</tradeName>
    <deviceName>Prana</deviceName>
    <manufacturerName>Open Bionics Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000032650</manufacturerSrn>
    <authorisedRepresentativeName>European Healthcare &amp; Device Solutions Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003999</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y060680</emdnCode>
    <emdnDescription>UPPER LIMB ORTHOSES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>300072</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:29:38.897Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060639240708</udiDi>
    <basicUdiDi>506063924MYOPODHQ</basicUdiDi>
    <tradeName>MyoPods</tradeName>
    <deviceName>MyoPods</deviceName>
    <manufacturerName>Open Bionics Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000032650</manufacturerSrn>
    <authorisedRepresentativeName>European Healthcare &amp; Device Solutions Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003999</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P090499</emdnCode>
    <emdnDescription>HAND PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5001119</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:29:38.091Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060639240548</udiDi>
    <basicUdiDi>506063924HEROPROKP</basicUdiDi>
    <tradeName>Hero PRO</tradeName>
    <deviceName>Hero PRO</deviceName>
    <manufacturerName>Open Bionics Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000032650</manufacturerSrn>
    <authorisedRepresentativeName>European Healthcare &amp; Device Solutions Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003999</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P090499</emdnCode>
    <emdnDescription>HAND PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5001105</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:29:37.271Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060639240531</udiDi>
    <basicUdiDi>506063924HERORGDJA</basicUdiDi>
    <tradeName>Hero RGD</tradeName>
    <deviceName>Hero RGD</deviceName>
    <manufacturerName>Open Bionics Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000032650</manufacturerSrn>
    <authorisedRepresentativeName>European Healthcare &amp; Device Solutions Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003999</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P090499</emdnCode>
    <emdnDescription>HAND PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5001105</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:29:36.470Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060639240524</udiDi>
    <basicUdiDi>506063924HEROGAUNTLETZ9</basicUdiDi>
    <tradeName>Hero Gauntlet</tradeName>
    <deviceName>Hero Gauntlet</deviceName>
    <manufacturerName>Open Bionics Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000032650</manufacturerSrn>
    <authorisedRepresentativeName>European Healthcare &amp; Device Solutions Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003999</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P090499</emdnCode>
    <emdnDescription>HAND PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5001023</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:29:35.663Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060639240418</udiDi>
    <basicUdiDi>506063924HEROFLEXV9</basicUdiDi>
    <tradeName>Hero Flex</tradeName>
    <deviceName>Hero Flex</deviceName>
    <manufacturerName>Open Bionics Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000032650</manufacturerSrn>
    <authorisedRepresentativeName>European Healthcare &amp; Device Solutions Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003999</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P090299</emdnCode>
    <emdnDescription>ELBOW PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5001015</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:29:34.057Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060639240005</udiDi>
    <basicUdiDi>506063924HeroArmFP</basicUdiDi>
    <tradeName>Hero Arm</tradeName>
    <deviceName>Hero Arm</deviceName>
    <manufacturerName>Open Bionics Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000032650</manufacturerSrn>
    <authorisedRepresentativeName>European Healthcare &amp; Device Solutions Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003999</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P090499</emdnCode>
    <emdnDescription>HAND PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4001004</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:29:32.471Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060615290000</udiDi>
    <basicUdiDi>506061529NervecentreEPRMR</basicUdiDi>
    <tradeName>NervecentreEPR</tradeName>
    <deviceName>NervecentreEPR</deviceName>
    <manufacturerName>Nervecentre Software Ltd</manufacturerName>
    <manufacturerSrn>UK-MF-000042892</manufacturerSrn>
    <authorisedRepresentativeName>European Healthcare &amp; Device Solutions Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003999</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12040282</emdnCode>
    <emdnDescription>GENERAL MEDICINE THERAPEUTIC TREATMENT INSTRUMENTS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NervecentreEPR</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:26:03.790Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060504271189</udiDi>
    <basicUdiDi>506050427castcutter9G</basicUdiDi>
    <tradeName>Medecast</tradeName>
    <deviceName>Medecast Cast Cutter with Vacuum</deviceName>
    <manufacturerName>Medezine Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000020018</manufacturerSrn>
    <authorisedRepresentativeName>European Healthcare &amp; Device Solutions Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003999</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12139005</emdnCode>
    <emdnDescription>PLASTER CAST SAWS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MCVS1</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:22:39.501Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060465562654</udiDi>
    <basicUdiDi>506046556520-11C9</basicUdiDi>
    <tradeName>05060465562654</tradeName>
    <deviceName>Laserguard Silicone Bite Guard</deviceName>
    <manufacturerName>Medasil Surgical Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000009549</manufacturerSrn>
    <authorisedRepresentativeName>European Healthcare &amp; Device Solutions Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003999</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T0306</emdnCode>
    <emdnDescription>PATIENT PROTECTION DEVICES DURING CLINICAL PROCEDURES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>520-1120-0002</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:18:32.513Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060465562593</udiDi>
    <basicUdiDi>506046556510-11BW</basicUdiDi>
    <tradeName>05060465562593</tradeName>
    <deviceName>Laserguard Silicone Ocular Shield</deviceName>
    <manufacturerName>Medasil Surgical Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000009549</manufacturerSrn>
    <authorisedRepresentativeName>European Healthcare &amp; Device Solutions Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003999</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T0306</emdnCode>
    <emdnDescription>PATIENT PROTECTION DEVICES DURING CLINICAL PROCEDURES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>510-1101-2204</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:18:31.734Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060465562555</udiDi>
    <basicUdiDi>506046556640-11DC</basicUdiDi>
    <tradeName>05060465562555</tradeName>
    <deviceName>Sterile Silicone Surgical Sheet</deviceName>
    <manufacturerName>Medasil Surgical Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000009549</manufacturerSrn>
    <authorisedRepresentativeName>European Healthcare &amp; Device Solutions Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003999</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>M04040701</emdnCode>
    <emdnDescription>SILICONE DRESSINGS, NON-COMBINED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>640-1101-0000</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:18:30.928Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060465562111</udiDi>
    <basicUdiDi>506046556411-11BQ</basicUdiDi>
    <tradeName>05060465562111</tradeName>
    <deviceName>Silicone Drain- Multitubular</deviceName>
    <manufacturerName>Medasil Surgical Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000009549</manufacturerSrn>
    <authorisedRepresentativeName>European Healthcare &amp; Device Solutions Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003999</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A06010199</emdnCode>
    <emdnDescription>VACUUM AND GRAVITY DRAINAGE SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>411-1110-4515</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:18:30.136Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060465561930</udiDi>
    <basicUdiDi>506046556410-11BH</basicUdiDi>
    <tradeName>05060465561930</tradeName>
    <deviceName>Sterile Silicone Wound Drain- Perforated</deviceName>
    <manufacturerName>Medasil Surgical Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000009549</manufacturerSrn>
    <authorisedRepresentativeName>European Healthcare &amp; Device Solutions Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003999</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A06010199</emdnCode>
    <emdnDescription>VACUUM AND GRAVITY DRAINAGE SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>410-1110-3216</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:18:29.356Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060465562173</udiDi>
    <basicUdiDi>506046556420-11BU</basicUdiDi>
    <tradeName>05060465562173</tradeName>
    <deviceName>Sterile Silicone Nerve Vessel Loops</deviceName>
    <manufacturerName>Medasil Surgical Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000009549</manufacturerSrn>
    <authorisedRepresentativeName>European Healthcare &amp; Device Solutions Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003999</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V9099</emdnCode>
    <emdnDescription>VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>420-1130-1591</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:18:28.567Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060465562159</udiDi>
    <basicUdiDi>506046556412-11BX</basicUdiDi>
    <tradeName>05060465562159</tradeName>
    <deviceName>Sterile Silicone Ribbon Drain</deviceName>
    <manufacturerName>Medasil Surgical Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000009549</manufacturerSrn>
    <authorisedRepresentativeName>European Healthcare &amp; Device Solutions Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003999</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A06010199</emdnCode>
    <emdnDescription>VACUUM AND GRAVITY DRAINAGE SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>412-1110-0745</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:18:27.829Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060465561657</udiDi>
    <basicUdiDi>506046556261-11CM</basicUdiDi>
    <tradeName>05060465561657</tradeName>
    <deviceName>Sterile Silicone Tubing</deviceName>
    <manufacturerName>Medasil Surgical Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000009549</manufacturerSrn>
    <authorisedRepresentativeName>European Healthcare &amp; Device Solutions Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003999</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A0399</emdnCode>
    <emdnDescription>TUBULAR DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>261-1110-1504-0103</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:18:14.048Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060465560674</udiDi>
    <basicUdiDi>506046556260-10CC</basicUdiDi>
    <tradeName>05060465560674</tradeName>
    <deviceName>Silicone Tubing (Non Sterile)</deviceName>
    <manufacturerName>Medasil Surgical Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000009549</manufacturerSrn>
    <authorisedRepresentativeName>European Healthcare &amp; Device Solutions Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003999</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A0399</emdnCode>
    <emdnDescription>TUBULAR DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>260-1001-0617</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:18:13.256Z</lastUpdated>
  </row>
</eudamedExport>