<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>+B36511268010</udiDi>
    <basicUdiDi>++B365ELEKTAACCBCYB</basicUdiDi>
    <tradeName>Beam Block Elekta</tradeName>
    <deviceName>Universal Leveling Template 25x25</deviceName>
    <manufacturerName>Aktina Medical Corp</manufacturerName>
    <manufacturerSrn>US-MF-000005935</manufacturerSrn>
    <authorisedRepresentativeName>European Healthcare &amp; Device Solutions Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003999</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11010199</emdnCode>
    <emdnDescription>LINEAR ACCELERATORS – OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11-268-01</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:48:04.980Z</lastUpdated>
  </row>
  <row>
    <udiDi>+B365112350</udiDi>
    <basicUdiDi>++B365ELEKTAACCIMZL</basicUdiDi>
    <tradeName>Cassette Holder</tradeName>
    <deviceName>Lateral Cassette Holder -  Elekta</deviceName>
    <manufacturerName>Aktina Medical Corp</manufacturerName>
    <manufacturerSrn>US-MF-000005935</manufacturerSrn>
    <authorisedRepresentativeName>European Healthcare &amp; Device Solutions Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003999</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11010199</emdnCode>
    <emdnDescription>LINEAR ACCELERATORS – OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11-235</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:48:04.179Z</lastUpdated>
  </row>
  <row>
    <udiDi>+B3651122005</udiDi>
    <basicUdiDi>++B36511229EP</basicUdiDi>
    <tradeName>Breast Board</tradeName>
    <deviceName>Breast Board</deviceName>
    <manufacturerName>Aktina Medical Corp</manufacturerName>
    <manufacturerSrn>US-MF-000005935</manufacturerSrn>
    <authorisedRepresentativeName>European Healthcare &amp; Device Solutions Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003999</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11010199</emdnCode>
    <emdnDescription>LINEAR ACCELERATORS – OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11-220-05</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:48:03.386Z</lastUpdated>
  </row>
  <row>
    <udiDi>+B365112160</udiDi>
    <basicUdiDi>++B36551200FB</basicUdiDi>
    <tradeName>AK550 Table Top</tradeName>
    <deviceName>Mesh Insert. Carbon Fiber. Central Opening.</deviceName>
    <manufacturerName>Aktina Medical Corp</manufacturerName>
    <manufacturerSrn>US-MF-000005935</manufacturerSrn>
    <authorisedRepresentativeName>European Healthcare &amp; Device Solutions Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003999</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11010199</emdnCode>
    <emdnDescription>LINEAR ACCELERATORS – OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11-216</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:48:02.580Z</lastUpdated>
  </row>
  <row>
    <udiDi>+B365112050</udiDi>
    <basicUdiDi>++B365ELEKTAACCPI24</basicUdiDi>
    <tradeName>Table Top Accessory Elekta</tradeName>
    <deviceName>Elekta Tennis Racquet Table Insert, Metal</deviceName>
    <manufacturerName>Aktina Medical Corp</manufacturerName>
    <manufacturerSrn>US-MF-000005935</manufacturerSrn>
    <authorisedRepresentativeName>European Healthcare &amp; Device Solutions Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003999</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11010199</emdnCode>
    <emdnDescription>LINEAR ACCELERATORS – OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11-205</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:47:58.586Z</lastUpdated>
  </row>
  <row>
    <udiDi>+B365112020</udiDi>
    <basicUdiDi>++B36511213E8</basicUdiDi>
    <tradeName>Table Top Accessory Elekta</tradeName>
    <deviceName>Oblique Treatment Panel with Inserts</deviceName>
    <manufacturerName>Aktina Medical Corp</manufacturerName>
    <manufacturerSrn>US-MF-000005935</manufacturerSrn>
    <authorisedRepresentativeName>European Healthcare &amp; Device Solutions Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003999</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11010199</emdnCode>
    <emdnDescription>LINEAR ACCELERATORS – OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11-202</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:47:57.797Z</lastUpdated>
  </row>
  <row>
    <udiDi>+B3651120008011</udiDi>
    <basicUdiDi>++B3651120008ABCVW</basicUdiDi>
    <tradeName>Mouthpiece and Filter ABC</tradeName>
    <deviceName>ABC Mouthpiece and Filter Kit (20 per box)</deviceName>
    <manufacturerName>Aktina Medical Corp</manufacturerName>
    <manufacturerSrn>US-MF-000005935</manufacturerSrn>
    <authorisedRepresentativeName>European Healthcare &amp; Device Solutions Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003999</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11010185</emdnCode>
    <emdnDescription>LINEAR ACCELERATORS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11-200-08-01</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:47:56.993Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-T-300_SN1220149E4</udiDi>
    <basicUdiDi>B-T-300_SN1220149E4</basicUdiDi>
    <tradeName>Womed T-300</tradeName>
    <deviceName></deviceName>
    <manufacturerName>WOLF-Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005165</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11010301</emdnCode>
    <emdnDescription>BRACHYTHERAPY RADIATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6419</reference>
    <placedOnMarketCountry>Slovakia</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:49:51.278Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-T-200_SN1220155CN</udiDi>
    <basicUdiDi>B-T-200_SN1220155CN</basicUdiDi>
    <tradeName>Womed T-200</tradeName>
    <deviceName></deviceName>
    <manufacturerName>WOLF-Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005165</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11010301</emdnCode>
    <emdnDescription>BRACHYTHERAPY RADIATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4290</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:49:50.479Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-T-200_SN1220154CL</udiDi>
    <basicUdiDi>B-T-200_SN1220154CL</basicUdiDi>
    <tradeName>Womed T-200</tradeName>
    <deviceName></deviceName>
    <manufacturerName>WOLF-Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005165</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11010301</emdnCode>
    <emdnDescription>BRACHYTHERAPY RADIATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4290</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:49:49.681Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-T-200_SN1220150CC</udiDi>
    <basicUdiDi>B-T-200_SN1220150CC</basicUdiDi>
    <tradeName>Womed T-200</tradeName>
    <deviceName></deviceName>
    <manufacturerName>WOLF-Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005165</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11010301</emdnCode>
    <emdnDescription>BRACHYTHERAPY RADIATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4290</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:49:48.879Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-T-200_SN1220148CR</udiDi>
    <basicUdiDi>B-T-200_SN1220148CR</basicUdiDi>
    <tradeName>Womed T-200</tradeName>
    <deviceName></deviceName>
    <manufacturerName>WOLF-Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005165</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11010301</emdnCode>
    <emdnDescription>BRACHYTHERAPY RADIATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4290</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:49:44.877Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-T-200R4</udiDi>
    <basicUdiDi>B-T-200R4</basicUdiDi>
    <tradeName>Womed T-200</tradeName>
    <deviceName></deviceName>
    <manufacturerName>WOLF-Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005165</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11010301</emdnCode>
    <emdnDescription>BRACHYTHERAPY RADIATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4202</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:49:44.079Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-T-160_SN1220156JD</udiDi>
    <basicUdiDi>B-T-160_SN1220156JD</basicUdiDi>
    <tradeName>Womed T-160</tradeName>
    <deviceName></deviceName>
    <manufacturerName>WOLF-Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005165</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11010301</emdnCode>
    <emdnDescription>BRACHYTHERAPY RADIATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6571</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:49:43.290Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-T-105_SN1222040G4</udiDi>
    <basicUdiDi>B-T-105_SN1222040G4</basicUdiDi>
    <tradeName>Womed T-105</tradeName>
    <deviceName></deviceName>
    <manufacturerName>WOLF-Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005165</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11010301</emdnCode>
    <emdnDescription>BRACHYTHERAPY RADIATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7441</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:49:42.480Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816389027039</udiDi>
    <basicUdiDi>089947500201065Q6</basicUdiDi>
    <tradeName>Luer transfer guide tube with integrated channel 14 Quick Connect</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Varian Medical Systems, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000001784</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthineers Nederland B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000803</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z11010380</emdnCode>
    <emdnDescription>BRACHYTHERAPY RADIATION SYSTEMS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GM19004140</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T03:46:09.801Z</lastUpdated>
  </row>
  <row>
    <udiDi>05420028754122</udiDi>
    <basicUdiDi>54200287002756</basicUdiDi>
    <tradeName>LEG SUPPORT</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Orfit Industries</manufacturerName>
    <manufacturerSrn>BE-MF-000007872</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11010980</emdnCode>
    <emdnDescription>MAGNETIC RESONANCE RADIOTHERAPY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>32005/10-V2</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-14T19:49:02.023Z</lastUpdated>
  </row>
  <row>
    <udiDi>05420028754139</udiDi>
    <basicUdiDi>54200287002756</basicUdiDi>
    <tradeName>FOOT SUPPORT</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Orfit Industries</manufacturerName>
    <manufacturerSrn>BE-MF-000007872</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11010980</emdnCode>
    <emdnDescription>MAGNETIC RESONANCE RADIOTHERAPY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>32005/11-V2</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-14T19:49:02.004Z</lastUpdated>
  </row>
  <row>
    <udiDi>05420028754146</udiDi>
    <basicUdiDi>54200287002756</basicUdiDi>
    <tradeName>Cylindrical Knee Support Cushion</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Orfit Industries</manufacturerName>
    <manufacturerSrn>BE-MF-000007872</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11010980</emdnCode>
    <emdnDescription>MAGNETIC RESONANCE RADIOTHERAPY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>32005/14-V2</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-14T19:49:01.880Z</lastUpdated>
  </row>
  <row>
    <udiDi>05420028754153</udiDi>
    <basicUdiDi>54200287002756</basicUdiDi>
    <tradeName>HALF CYLINDRICAL KNEE SUPPORT</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Orfit Industries</manufacturerName>
    <manufacturerSrn>BE-MF-000007872</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11010980</emdnCode>
    <emdnDescription>MAGNETIC RESONANCE RADIOTHERAPY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>32005/15-V2</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-14T19:49:01.860Z</lastUpdated>
  </row>
</eudamedExport>