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<eudamedExport entity="devices">
  <row>
    <udiDi>00850055427068</udiDi>
    <basicUdiDi>0850055427HY1000QB</basicUdiDi>
    <tradeName>HYDROS Robotic System</tradeName>
    <deviceName>HYDROS Robotic System</deviceName>
    <manufacturerName>PROCEPT BioRobotics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000015560</manufacturerSrn>
    <authorisedRepresentativeName>Qualrep Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000537</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z120106</emdnCode>
    <emdnDescription>HYDRODISSECTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HY1000</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:30:42.510Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850055427051</udiDi>
    <basicUdiDi>0850055427HH1000JG</basicUdiDi>
    <tradeName>HYDROS Handpiece</tradeName>
    <deviceName>HYDROS Handpiece</deviceName>
    <manufacturerName>PROCEPT BioRobotics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000015560</manufacturerSrn>
    <authorisedRepresentativeName>Qualrep Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000537</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z120106</emdnCode>
    <emdnDescription>HYDRODISSECTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HH1000</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:30:40.927Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850055427020</udiDi>
    <basicUdiDi>0850055427AB2000DS</basicUdiDi>
    <tradeName>AquaBeam Robotic System</tradeName>
    <deviceName>AquaBeam Robotic System</deviceName>
    <manufacturerName>PROCEPT BioRobotics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000015560</manufacturerSrn>
    <authorisedRepresentativeName>Qualrep Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000537</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z120106</emdnCode>
    <emdnDescription>HYDRODISSECTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AB2000</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:30:38.514Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850055427006</udiDi>
    <basicUdiDi>0850055427HP2000MF</basicUdiDi>
    <tradeName>AquaBeam Handpiece</tradeName>
    <deviceName>AquaBeam Handpiece</deviceName>
    <manufacturerName>PROCEPT BioRobotics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000015560</manufacturerSrn>
    <authorisedRepresentativeName>Qualrep Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000537</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z120106</emdnCode>
    <emdnDescription>HYDRODISSECTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HP2000</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:30:34.533Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050147020184</udiDi>
    <basicUdiDi>B-04050147020184</basicUdiDi>
    <tradeName>Pumpeneinheit plus</tradeName>
    <deviceName>Pump cartridge for ERBEJET 2, SU</deviceName>
    <manufacturerName>Erbe Elektromedizin GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005498</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z120106</emdnCode>
    <emdnDescription>HYDRODISSECTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20150-301</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:38:18.823Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050147019447</udiDi>
    <basicUdiDi>B-04050147019447</basicUdiDi>
    <tradeName>Applikator m. Absaugung</tradeName>
    <deviceName>Hydrosurgical applicators, SU</deviceName>
    <manufacturerName>Erbe Elektromedizin GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005498</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z120106</emdnCode>
    <emdnDescription>HYDRODISSECTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20150-239</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:38:14.042Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050147019430</udiDi>
    <basicUdiDi>B-04050147019430</basicUdiDi>
    <tradeName>Applikator m. Absaugung</tradeName>
    <deviceName>Hydrosurgical applicators, SU</deviceName>
    <manufacturerName>Erbe Elektromedizin GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005498</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z120106</emdnCode>
    <emdnDescription>HYDRODISSECTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20150-231</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:38:13.228Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050147018327</udiDi>
    <basicUdiDi>B-04050147018327</basicUdiDi>
    <tradeName>Zweiped.-Fußsch. ERBEJET®2</tradeName>
    <deviceName>Footswitch, hydrosurgery systems</deviceName>
    <manufacturerName>Erbe Elektromedizin GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005498</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z120106</emdnCode>
    <emdnDescription>HYDRODISSECTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20150-103</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:38:07.620Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050147015371</udiDi>
    <basicUdiDi>B-04050147015371</basicUdiDi>
    <tradeName>Einped.-Fußsch. ERBEJET® 2</tradeName>
    <deviceName>Footswitch, hydrosurgery systems</deviceName>
    <manufacturerName>Erbe Elektromedizin GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005498</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z120106</emdnCode>
    <emdnDescription>HYDRODISSECTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20150-102</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:37:53.213Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050147011021</udiDi>
    <basicUdiDi>B-04050147011021</basicUdiDi>
    <tradeName>Applikator; gerade</tradeName>
    <deviceName>Hydrosurgical applicators, SU</deviceName>
    <manufacturerName>Erbe Elektromedizin GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005498</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z120106</emdnCode>
    <emdnDescription>HYDRODISSECTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20150-039</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:30:20.810Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050147011014</udiDi>
    <basicUdiDi>B-04050147011014</basicUdiDi>
    <tradeName>Applikator; flexible Spitze</tradeName>
    <deviceName>Hydrosurgical applicators, SU</deviceName>
    <manufacturerName>Erbe Elektromedizin GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005498</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z120106</emdnCode>
    <emdnDescription>HYDRODISSECTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20150-031</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:30:20.012Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050147010062</udiDi>
    <basicUdiDi>B-04050147010062</basicUdiDi>
    <tradeName>Zweipedal-Fußsch. ERBEJET® 2</tradeName>
    <deviceName>Footswitch, hydrosurgery systems</deviceName>
    <manufacturerName>Erbe Elektromedizin GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005498</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z120106</emdnCode>
    <emdnDescription>HYDRODISSECTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20150-100</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:29:20.705Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050147001916</udiDi>
    <basicUdiDi>B-04050147001916</basicUdiDi>
    <tradeName>Applikator m. Absaugung</tradeName>
    <deviceName>Hydrosurgical applicators, SU</deviceName>
    <manufacturerName>Erbe Elektromedizin GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005498</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z120106</emdnCode>
    <emdnDescription>HYDRODISSECTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20150-238</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:26:47.648Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050147001909</udiDi>
    <basicUdiDi>B-04050147001909</basicUdiDi>
    <tradeName>Applikator m. Absaugung</tradeName>
    <deviceName>Hydrosurgical applicators, SU</deviceName>
    <manufacturerName>Erbe Elektromedizin GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005498</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z120106</emdnCode>
    <emdnDescription>HYDRODISSECTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20150-230</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:26:46.848Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050147001893</udiDi>
    <basicUdiDi>B-04050147001893</basicUdiDi>
    <tradeName>Applikator, ø 5mm; L 336mm</tradeName>
    <deviceName>Hydrosurgical applicators, SU</deviceName>
    <manufacturerName>Erbe Elektromedizin GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005498</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z120106</emdnCode>
    <emdnDescription>HYDRODISSECTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20150-226</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:26:46.054Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050147001886</udiDi>
    <basicUdiDi>B-04050147001886</basicUdiDi>
    <tradeName>Applikator, ø 5mm; L 183mm</tradeName>
    <deviceName>Hydrosurgical applicators, SU</deviceName>
    <manufacturerName>Erbe Elektromedizin GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005498</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z120106</emdnCode>
    <emdnDescription>HYDRODISSECTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20150-225</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:26:45.248Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050147001879</udiDi>
    <basicUdiDi>B-04050147001879</basicUdiDi>
    <tradeName>ERBEJET®-Sonde; flexibel</tradeName>
    <deviceName>Hydrosurgical applicators, SU</deviceName>
    <manufacturerName>Erbe Elektromedizin GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005498</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z120106</emdnCode>
    <emdnDescription>HYDRODISSECTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20150-220</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:26:40.446Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050147001862</udiDi>
    <basicUdiDi>B-04050147001862</basicUdiDi>
    <tradeName>Einpedal-Fußsch. ERBEJET® 2</tradeName>
    <deviceName>Footswitch, hydrosurgery systems</deviceName>
    <manufacturerName>Erbe Elektromedizin GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005498</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z120106</emdnCode>
    <emdnDescription>HYDRODISSECTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20150-101</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:26:39.660Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050147001848</udiDi>
    <basicUdiDi>B-04050147001848</basicUdiDi>
    <tradeName>Applikator; bajonett</tradeName>
    <deviceName>Hydrosurgical applicators, SU</deviceName>
    <manufacturerName>Erbe Elektromedizin GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005498</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z120106</emdnCode>
    <emdnDescription>HYDRODISSECTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20150-041</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:26:38.878Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050147001831</udiDi>
    <basicUdiDi>B-04050147001831</basicUdiDi>
    <tradeName>Applikator; gerade</tradeName>
    <deviceName>Hydrosurgical applicators, SU</deviceName>
    <manufacturerName>Erbe Elektromedizin GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005498</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z120106</emdnCode>
    <emdnDescription>HYDRODISSECTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20150-038</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:26:38.048Z</lastUpdated>
  </row>
</eudamedExport>