<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00821925043701</udiDi>
    <basicUdiDi>08219250000155</basicUdiDi>
    <tradeName>00821925043701</tradeName>
    <deviceName>ShockPulse lithotripsy accessories (nosecone, wrench, stylet)</deviceName>
    <manufacturerName>Gyrus ACMI, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000034237</manufacturerSrn>
    <authorisedRepresentativeName>Olympus Europa SE &amp; Co. KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006774</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12010880</emdnCode>
    <emdnDescription>INSTRUMENTS FOR ULTRASONIC SURGERY - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SPL-NC</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T19:47:38.925Z</lastUpdated>
  </row>
  <row>
    <udiDi>06939282409468</udiDi>
    <basicUdiDi>69392824USSG1000G3</basicUdiDi>
    <tradeName>06939282409468</tradeName>
    <deviceName>Ultrasonic surgical system generator</deviceName>
    <manufacturerName>B.J.ZH.F.Panther Medical Equipment Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018084</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12010880</emdnCode>
    <emdnDescription>INSTRUMENTS FOR ULTRASONIC SURGERY - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MKF21S/1S-MEDGP212</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-16T07:38:08.713Z</lastUpdated>
  </row>
  <row>
    <udiDi>07613327291513</udiDi>
    <basicUdiDi>08858251004511SW</basicUdiDi>
    <tradeName>07613327291513</tradeName>
    <deviceName>Torque Wrench</deviceName>
    <manufacturerName>Stryker Instruments</manufacturerName>
    <manufacturerSrn>US-MF-000025219</manufacturerSrn>
    <authorisedRepresentativeName>Stryker European Operations Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000092</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12010880</emdnCode>
    <emdnDescription>INSTRUMENTS FOR ULTRASONIC SURGERY - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5450-800-039</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T04:32:10.968Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816995021513</udiDi>
    <basicUdiDi>081699502B0012W9</basicUdiDi>
    <tradeName>VASER RF WIRELESS FOOTSWITCH</tradeName>
    <deviceName>VENTX FOOTSWITCH</deviceName>
    <manufacturerName>Solta Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000018343</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12010880</emdnCode>
    <emdnDescription>INSTRUMENTS FOR ULTRASONIC SURGERY - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P010338</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:23:25.808Z</lastUpdated>
  </row>
  <row>
    <udiDi>10705036011934</udiDi>
    <basicUdiDi>0705036a000166M</basicUdiDi>
    <tradeName>HARMONIC</tradeName>
    <deviceName>HARMONIC Hand Switching Adaptor</deviceName>
    <manufacturerName>Ethicon Endo-Surgery, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000013107</manufacturerSrn>
    <authorisedRepresentativeName>Johnson &amp; Johnson Medical GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007712</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12010880</emdnCode>
    <emdnDescription>INSTRUMENTS FOR ULTRASONIC SURGERY - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HSA08</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-15T23:48:29.487Z</lastUpdated>
  </row>
  <row>
    <udiDi>10381780466215</udiDi>
    <basicUdiDi>038178B0202CSS2A</basicUdiDi>
    <tradeName>CUSA® Clarity</tradeName>
    <deviceName>Nosecone</deviceName>
    <manufacturerName>Integra LifeSciences (Ireland) Limited</manufacturerName>
    <manufacturerSrn>IE-MF-000003849</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12010885</emdnCode>
    <emdnDescription>INSTRUMENTS FOR ULTRASONIC SURGERY - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C7523</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:29:13.505Z</lastUpdated>
  </row>
  <row>
    <udiDi>10381780126300</udiDi>
    <basicUdiDi>038178B0198CSS6A</basicUdiDi>
    <tradeName>CUSA® Clarity</tradeName>
    <deviceName>Torque Wrench</deviceName>
    <manufacturerName>Integra LifeSciences (Ireland) Limited</manufacturerName>
    <manufacturerSrn>IE-MF-000003849</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12010885</emdnCode>
    <emdnDescription>INSTRUMENTS FOR ULTRASONIC SURGERY - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C7602</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:29:07.224Z</lastUpdated>
  </row>
  <row>
    <udiDi>10381780126287</udiDi>
    <basicUdiDi>038178B0201CSS23</basicUdiDi>
    <tradeName>CUSA® Clarity</tradeName>
    <deviceName>Quick Connect Cartridge and Tubing Set</deviceName>
    <manufacturerName>Integra LifeSciences (Ireland) Limited</manufacturerName>
    <manufacturerSrn>IE-MF-000003849</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12010885</emdnCode>
    <emdnDescription>INSTRUMENTS FOR ULTRASONIC SURGERY - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C7300</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:29:06.397Z</lastUpdated>
  </row>
  <row>
    <udiDi>10381780126263</udiDi>
    <basicUdiDi>038178B0200CSSZR</basicUdiDi>
    <tradeName>CUSA® Clarity</tradeName>
    <deviceName>Handpiece</deviceName>
    <manufacturerName>Integra LifeSciences (Ireland) Limited</manufacturerName>
    <manufacturerSrn>IE-MF-000003849</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12010880</emdnCode>
    <emdnDescription>INSTRUMENTS FOR ULTRASONIC SURGERY - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C7036</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:29:05.577Z</lastUpdated>
  </row>
  <row>
    <udiDi>10381780126232</udiDi>
    <basicUdiDi>038178B0199CSS6H</basicUdiDi>
    <tradeName>CUSA® Clarity</tradeName>
    <deviceName>Ultrasonic Surgical Aspirator System</deviceName>
    <manufacturerName>Integra LifeSciences (Ireland) Limited</manufacturerName>
    <manufacturerSrn>IE-MF-000003849</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12010880</emdnCode>
    <emdnDescription>INSTRUMENTS FOR ULTRASONIC SURGERY - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C7000</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:29:04.740Z</lastUpdated>
  </row>
  <row>
    <udiDi>+E322051700020</udiDi>
    <basicUdiDi>++E322PiezosurgeryM0400YM</basicUdiDi>
    <tradeName>PIEZOSURGERY flex</tradeName>
    <deviceName>PIEZOSURGERY plus</deviceName>
    <manufacturerName>Mectron S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000024418</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12010801</emdnCode>
    <emdnDescription>ULTRASONIC SCALPEL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>05170002</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T15:43:34.688Z</lastUpdated>
  </row>
  <row>
    <udiDi>10381780466321</udiDi>
    <basicUdiDi>038178B0200CSSZR</basicUdiDi>
    <tradeName>CUSA® Clarity</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Integra LifeSciences (Ireland) Limited</manufacturerName>
    <manufacturerSrn>IE-MF-000003849</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12010880</emdnCode>
    <emdnDescription>INSTRUMENTS FOR ULTRASONIC SURGERY - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C7023RR</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-10T19:45:18.914Z</lastUpdated>
  </row>
  <row>
    <udiDi>10381780357483</udiDi>
    <basicUdiDi>038178B0200CSSZR</basicUdiDi>
    <tradeName>CUSA® Clarity</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Integra LifeSciences (Ireland) Limited</manufacturerName>
    <manufacturerSrn>IE-MF-000003849</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12010880</emdnCode>
    <emdnDescription>INSTRUMENTS FOR ULTRASONIC SURGERY - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C7036RR</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-10T19:45:05.935Z</lastUpdated>
  </row>
  <row>
    <udiDi>10381780126294</udiDi>
    <basicUdiDi>038178B0201CSS23</basicUdiDi>
    <tradeName>CUSA® Clarity</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Integra LifeSciences (Ireland) Limited</manufacturerName>
    <manufacturerSrn>IE-MF-000003849</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12010885</emdnCode>
    <emdnDescription>INSTRUMENTS FOR ULTRASONIC SURGERY - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C7300EA</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-10T19:45:05.600Z</lastUpdated>
  </row>
  <row>
    <udiDi>10381780466383</udiDi>
    <basicUdiDi>038178B0202CSS2A</basicUdiDi>
    <tradeName>CUSA® Clarity</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Integra LifeSciences (Ireland) Limited</manufacturerName>
    <manufacturerSrn>IE-MF-000003849</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12010885</emdnCode>
    <emdnDescription>INSTRUMENTS FOR ULTRASONIC SURGERY - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C7523EA</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-10T19:45:05.089Z</lastUpdated>
  </row>
  <row>
    <udiDi>10381780536383</udiDi>
    <basicUdiDi>038178B0202CSS2A</basicUdiDi>
    <tradeName>CUSA® Clarity</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Integra LifeSciences (Ireland) Limited</manufacturerName>
    <manufacturerSrn>IE-MF-000003849</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12010885</emdnCode>
    <emdnDescription>INSTRUMENTS FOR ULTRASONIC SURGERY - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C7523X</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-10T19:45:03.706Z</lastUpdated>
  </row>
  <row>
    <udiDi>10381780536376</udiDi>
    <basicUdiDi>038178B0202CSS2A</basicUdiDi>
    <tradeName>CUSA® Clarity</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Integra LifeSciences (Ireland) Limited</manufacturerName>
    <manufacturerSrn>IE-MF-000003849</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12010885</emdnCode>
    <emdnDescription>INSTRUMENTS FOR ULTRASONIC SURGERY - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C7523XEA</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-10T19:45:02.963Z</lastUpdated>
  </row>
  <row>
    <udiDi>10381780466406</udiDi>
    <basicUdiDi>038178B0198CSS6A</basicUdiDi>
    <tradeName>CUSA® Clarity</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Integra LifeSciences (Ireland) Limited</manufacturerName>
    <manufacturerSrn>IE-MF-000003849</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12010885</emdnCode>
    <emdnDescription>INSTRUMENTS FOR ULTRASONIC SURGERY - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C7601EA</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-10T19:45:02.002Z</lastUpdated>
  </row>
  <row>
    <udiDi>10381780126317</udiDi>
    <basicUdiDi>038178B0198CSS6A</basicUdiDi>
    <tradeName>CUSA® Clarity</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Integra LifeSciences (Ireland) Limited</manufacturerName>
    <manufacturerSrn>IE-MF-000003849</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12010885</emdnCode>
    <emdnDescription>INSTRUMENTS FOR ULTRASONIC SURGERY - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C7602EA</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-10T19:45:01.425Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809417421017</udiDi>
    <basicUdiDi>B-08809417421017</basicUdiDi>
    <tradeName>Ultrasonic Surgical Unit</tradeName>
    <deviceName>Ultrasonic Surgical Unit</deviceName>
    <manufacturerName>Zerone Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000014148</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12010801</emdnCode>
    <emdnDescription>ULTRASONIC SCALPEL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ULTRA-Z</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-10T11:05:19.178Z</lastUpdated>
  </row>
</eudamedExport>