<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-G4AS091LU</udiDi>
    <basicUdiDi>B-G4AS091LU</basicUdiDi>
    <tradeName>D-G4AS091LU</tradeName>
    <deviceName>iSR'obot MRI-US Fusion</deviceName>
    <manufacturerName>Biobot Surgical Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000020631</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12169082</emdnCode>
    <emdnDescription>VARIOUS INSTRUMENTS FOR UROLOGY - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>iSR'obot MRI-US Fusion</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:46:19.699Z</lastUpdated>
  </row>
  <row>
    <udiDi>10884521002050</udiDi>
    <basicUdiDi>B-10884521002050</basicUdiDi>
    <tradeName>10884521002050</tradeName>
    <deviceName>Dover Urine Drainage Bag, 2000 mL</deviceName>
    <manufacturerName>Covidien llc</manufacturerName>
    <manufacturerSrn>US-MF-000017721</manufacturerSrn>
    <authorisedRepresentativeName>Covidien Ireland Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000002274</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12169099</emdnCode>
    <emdnDescription>VARIOUS INSTRUMENTS FOR UROLOGY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6308</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:43:22.893Z</lastUpdated>
  </row>
  <row>
    <udiDi>08885014610351</udiDi>
    <basicUdiDi>B-08885014610351</basicUdiDi>
    <tradeName>08885014610351</tradeName>
    <deviceName>iSR'obot Mona Lisa</deviceName>
    <manufacturerName>Biobot Surgical Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000020631</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12169099</emdnCode>
    <emdnDescription>VARIOUS INSTRUMENTS FOR UROLOGY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>iSR'obot Mona Lisa</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T14:20:00.171Z</lastUpdated>
  </row>
  <row>
    <udiDi>08885014610023</udiDi>
    <basicUdiDi>B-08885014610023</basicUdiDi>
    <tradeName>08885014610023</tradeName>
    <deviceName>iSR'obot Biopsy Kit</deviceName>
    <manufacturerName>Biobot Surgical Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000020631</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12169085</emdnCode>
    <emdnDescription>VARIOUS INSTRUMENTS FOR UROLOGY - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G4AA610</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T14:19:59.409Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260661457889</udiDi>
    <basicUdiDi>42601239305JC</basicUdiDi>
    <tradeName>I9951502</tradeName>
    <deviceName></deviceName>
    <manufacturerName>provita medical gmbh &amp; co. kg</manufacturerName>
    <manufacturerSrn>DE-MF-000005332</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12169099</emdnCode>
    <emdnDescription>VARIOUS INSTRUMENTS FOR UROLOGY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>178204</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T19:52:52.432Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260661457704</udiDi>
    <basicUdiDi>42601239305JC</basicUdiDi>
    <tradeName>04260661457704</tradeName>
    <deviceName></deviceName>
    <manufacturerName>provita medical gmbh &amp; co. kg</manufacturerName>
    <manufacturerSrn>DE-MF-000005332</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12169099</emdnCode>
    <emdnDescription>VARIOUS INSTRUMENTS FOR UROLOGY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>253693</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T19:52:51.639Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260661454413</udiDi>
    <basicUdiDi>42601239305JC</basicUdiDi>
    <tradeName>I-U02238</tradeName>
    <deviceName></deviceName>
    <manufacturerName>provita medical gmbh &amp; co. kg</manufacturerName>
    <manufacturerSrn>DE-MF-000005332</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12169099</emdnCode>
    <emdnDescription>VARIOUS INSTRUMENTS FOR UROLOGY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>377054</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T19:52:35.549Z</lastUpdated>
  </row>
  <row>
    <udiDi>04262526340763</udiDi>
    <basicUdiDi>42601239305JC</basicUdiDi>
    <tradeName>04262526340763</tradeName>
    <deviceName></deviceName>
    <manufacturerName>provita medical gmbh &amp; co. kg</manufacturerName>
    <manufacturerSrn>DE-MF-000005332</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12169099</emdnCode>
    <emdnDescription>VARIOUS INSTRUMENTS FOR UROLOGY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>399719</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T19:52:32.471Z</lastUpdated>
  </row>
  <row>
    <udiDi>08885014610207</udiDi>
    <basicUdiDi>888501461iSRobotKit7V</basicUdiDi>
    <tradeName>iSR'obot Kit - 14G</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Biobot Surgical Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000020631</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12169085</emdnCode>
    <emdnDescription>VARIOUS INSTRUMENTS FOR UROLOGY - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AS-00005786</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T07:19:17.889Z</lastUpdated>
  </row>
  <row>
    <udiDi>08885014610221</udiDi>
    <basicUdiDi>888501461iSRobotKit7V</basicUdiDi>
    <tradeName>iSR'obot Kit - 17G</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Biobot Surgical Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000020631</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12169085</emdnCode>
    <emdnDescription>VARIOUS INSTRUMENTS FOR UROLOGY - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AS-00006415</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T07:19:17.867Z</lastUpdated>
  </row>
  <row>
    <udiDi>08885014610245</udiDi>
    <basicUdiDi>888501461iSRobotKit7V</basicUdiDi>
    <tradeName>08885014610245</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Biobot Surgical Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000020631</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12169085</emdnCode>
    <emdnDescription>VARIOUS INSTRUMENTS FOR UROLOGY - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AS-00005787</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T07:19:17.839Z</lastUpdated>
  </row>
  <row>
    <udiDi>08885014610399</udiDi>
    <basicUdiDi>888501461iSRobot25</basicUdiDi>
    <tradeName>08885014610399</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Biobot Surgical Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000020631</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12169099</emdnCode>
    <emdnDescription>VARIOUS INSTRUMENTS FOR UROLOGY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>iSR'obot Bed Rail Stabilizer</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T07:19:17.758Z</lastUpdated>
  </row>
  <row>
    <udiDi>08885014610429</udiDi>
    <basicUdiDi>888501461iSRobot25</basicUdiDi>
    <tradeName>08885014610429</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Biobot Surgical Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000020631</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12169099</emdnCode>
    <emdnDescription>VARIOUS INSTRUMENTS FOR UROLOGY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>iSR'obot Floor Stand Stabilizer</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T07:19:17.731Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033891270025</udiDi>
    <basicUdiDi>B-08033891270025</basicUdiDi>
    <tradeName>C-DAS N-DO® INIETTORE</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Physion S.R.L.</manufacturerName>
    <manufacturerSrn>IT-MF-000022194</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12169099</emdnCode>
    <emdnDescription>VARIOUS INSTRUMENTS FOR UROLOGY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PH00961109</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T14:55:40.473Z</lastUpdated>
  </row>
  <row>
    <udiDi>07630039100971</udiDi>
    <basicUdiDi>B-07630039100971</basicUdiDi>
    <tradeName>W-Medical Shockwave F1</tradeName>
    <deviceName>W-Medical Shockwave F1</deviceName>
    <manufacturerName>STORZ MEDICAL AG</manufacturerName>
    <manufacturerSrn>CH-MF-000014374</manufacturerSrn>
    <authorisedRepresentativeName>STORZ MEDICAL Deutschland GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000009017</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12169002</emdnCode>
    <emdnDescription>UROLOGICAL STIMULATORS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>27780.0011</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:57:08.844Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290010121069</udiDi>
    <basicUdiDi>B-07290010121069</basicUdiDi>
    <tradeName>Tubing-line disposable set</tradeName>
    <deviceName>Transurethral RF Ablation Applicator and Tubing Line with Soft Tip Disposable Set</deviceName>
    <manufacturerName>Medical Enterprises Europe B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000019133</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12169085</emdnCode>
    <emdnDescription>VARIOUS INSTRUMENTS FOR UROLOGY - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LI932B-S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T23:59:58.733Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290010121021</udiDi>
    <basicUdiDi>B-07290010121021</basicUdiDi>
    <tradeName>SB-TS 101.2</tradeName>
    <deviceName>Synergo® System SB-TS 101.2</deviceName>
    <manufacturerName>Medical Enterprises Europe B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000019133</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12169080</emdnCode>
    <emdnDescription>VARIOUS INSTRUMENTS FOR UROLOGY - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SB-TS 101.2</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T23:59:54.774Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290010121045</udiDi>
    <basicUdiDi>B-07290010121045</basicUdiDi>
    <tradeName>Synergo® System</tradeName>
    <deviceName>Synergo® System SB-TS 101.3</deviceName>
    <manufacturerName>Medical Enterprises Europe B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000019133</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12169080</emdnCode>
    <emdnDescription>VARIOUS INSTRUMENTS FOR UROLOGY - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SB-TS 101.3</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T23:59:54.135Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290010121038</udiDi>
    <basicUdiDi>B-07290010121038</basicUdiDi>
    <tradeName>Closed Drainage Set Bag</tradeName>
    <deviceName>Closed Drainage Set</deviceName>
    <manufacturerName>Medical Enterprises Europe B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000019133</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12169085</emdnCode>
    <emdnDescription>VARIOUS INSTRUMENTS FOR UROLOGY - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CDS932B</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-06T23:59:53.222Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290010121014</udiDi>
    <basicUdiDi>B-07290010121014</basicUdiDi>
    <tradeName>Transurethral RF Ablation Applicator</tradeName>
    <deviceName>Transurethral RF Ablation Applicator and Tubing Line Disposable Set</deviceName>
    <manufacturerName>Medical Enterprises Europe B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000019133</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12169085</emdnCode>
    <emdnDescription>VARIOUS INSTRUMENTS FOR UROLOGY - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LI932B</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T23:59:37.858Z</lastUpdated>
  </row>
</eudamedExport>