<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06970950280026</udiDi>
    <basicUdiDi>6970950282b003AW</basicUdiDi>
    <tradeName>Ultrasonic Surgical System Generator</tradeName>
    <deviceName>Ultrasonic Surgical System Generator</deviceName>
    <manufacturerName>Affacare Medical (Beijing) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025388</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12010801</emdnCode>
    <emdnDescription>ULTRASONIC SCALPEL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AH-611</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:20:55.072Z</lastUpdated>
  </row>
  <row>
    <udiDi>06939282409451</udiDi>
    <basicUdiDi>69392824USSG1000G3</basicUdiDi>
    <tradeName>06939282409451</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>Z12010801</emdnCode>
    <emdnDescription>ULTRASONIC SCALPEL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SG100</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:11:46.586Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800028800048</udiDi>
    <basicUdiDi>B-08800028800048</basicUdiDi>
    <tradeName>LIPOSOUND</tradeName>
    <deviceName>LIPOSOUND</deviceName>
    <manufacturerName>NEWPONG Co., Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000039922</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12010801</emdnCode>
    <emdnDescription>ULTRASONIC SCALPEL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NP-210</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T21:42:26.490Z</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>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>
  <row>
    <udiDi>08682079003087</udiDi>
    <basicUdiDi>B-08682079003087</basicUdiDi>
    <tradeName>Ultrasonic Surgical System</tradeName>
    <deviceName>Ultrasonic Surgical System Laparoscopic 23 cm</deviceName>
    <manufacturerName>KAF GRUP SAĞLIK HİZMETLERİ İNŞAAT SANAYİ VE TİCARET LİMİTED ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000018530</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12010801</emdnCode>
    <emdnDescription>ULTRASONIC SCALPEL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KAF-US-17</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T16:16:59.828Z</lastUpdated>
  </row>
  <row>
    <udiDi>08682079003056</udiDi>
    <basicUdiDi>B-08682079003056</basicUdiDi>
    <tradeName>Ultrasonic Surgical System</tradeName>
    <deviceName>Ultrasonic Surgical System-Open Surgery Shears 9cm</deviceName>
    <manufacturerName>KAF GRUP SAĞLIK HİZMETLERİ İNŞAAT SANAYİ VE TİCARET LİMİTED ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000018530</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12010801</emdnCode>
    <emdnDescription>ULTRASONIC SCALPEL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KAF-US-L14C</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T16:16:55.031Z</lastUpdated>
  </row>
  <row>
    <udiDi>08682079003049</udiDi>
    <basicUdiDi>B-08682079003049</basicUdiDi>
    <tradeName>Ultrasonic Surgical System</tradeName>
    <deviceName>Ultrasonic Surgucal System Open Surgery 23 cm</deviceName>
    <manufacturerName>KAF GRUP SAĞLIK HİZMETLERİ İNŞAAT SANAYİ VE TİCARET LİMİTED ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000018530</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12010801</emdnCode>
    <emdnDescription>ULTRASONIC SCALPEL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KAF-US-L23C</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T16:16:54.228Z</lastUpdated>
  </row>
  <row>
    <udiDi>08682079003032</udiDi>
    <basicUdiDi>B-08682079003032</basicUdiDi>
    <tradeName>Ultrasonic Surgical System</tradeName>
    <deviceName>Ultrasonic Surgical System Laparoscopic 36 cm</deviceName>
    <manufacturerName>KAF GRUP SAĞLIK HİZMETLERİ İNŞAAT SANAYİ VE TİCARET LİMİTED ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000018530</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12010801</emdnCode>
    <emdnDescription>ULTRASONIC SCALPEL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KAF-US-L36C</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T16:16:53.423Z</lastUpdated>
  </row>
  <row>
    <udiDi>08682079003025</udiDi>
    <basicUdiDi>B-08682079003025</basicUdiDi>
    <tradeName>Ultrasonic Surgical System</tradeName>
    <deviceName>Ultrasonic Surgical System Laparoscopic Shears 45 cm</deviceName>
    <manufacturerName>KAF GRUP SAĞLIK HİZMETLERİ İNŞAAT SANAYİ VE TİCARET LİMİTED ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000018530</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12010801</emdnCode>
    <emdnDescription>ULTRASONIC SCALPEL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KAF-US-L45C</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T16:16:48.629Z</lastUpdated>
  </row>
  <row>
    <udiDi>08682079003018</udiDi>
    <basicUdiDi>B-08682079003018</basicUdiDi>
    <tradeName>Ultrasonic Surgical System</tradeName>
    <deviceName>Ultrasonic Surgical System</deviceName>
    <manufacturerName>KAF GRUP SAĞLIK HİZMETLERİ İNŞAAT SANAYİ VE TİCARET LİMİTED ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000018530</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12010801</emdnCode>
    <emdnDescription>ULTRASONIC SCALPEL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KAF-US-T23</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T16:16:47.852Z</lastUpdated>
  </row>
  <row>
    <udiDi>08682079003001</udiDi>
    <basicUdiDi>B-08682079003001</basicUdiDi>
    <tradeName>Ultrasonic Surgical System</tradeName>
    <deviceName>Ultrasonic Surgical System Generator</deviceName>
    <manufacturerName>KAF GRUP SAĞLIK HİZMETLERİ İNŞAAT SANAYİ VE TİCARET LİMİTED ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000018530</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12010801</emdnCode>
    <emdnDescription>ULTRASONIC SCALPEL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KAF-US-2200</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T16:16:47.028Z</lastUpdated>
  </row>
  <row>
    <udiDi>08059772960052</udiDi>
    <basicUdiDi>805977296HANSL</basicUdiDi>
    <tradeName>Manipolo 27 kHz per K-Bisonic/K-Sonic</tradeName>
    <deviceName></deviceName>
    <manufacturerName>KIRMED INTERNATIONAL SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000035071</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12010801</emdnCode>
    <emdnDescription>ULTRASONIC SCALPEL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K077-10</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:37:52.724Z</lastUpdated>
  </row>
  <row>
    <udiDi>08059772960021</udiDi>
    <basicUdiDi>805977296KSOUT</basicUdiDi>
    <tradeName>Console sistema elettromedicale K-Sonic2</tradeName>
    <deviceName></deviceName>
    <manufacturerName>KIRMED INTERNATIONAL SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000035071</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12010801</emdnCode>
    <emdnDescription>ULTRASONIC SCALPEL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K0770-2</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:37:36.671Z</lastUpdated>
  </row>
  <row>
    <udiDi>08059772960007</udiDi>
    <basicUdiDi>805977296KBISU</basicUdiDi>
    <tradeName>Console sistema elettromedicale K-Bisonic2</tradeName>
    <deviceName></deviceName>
    <manufacturerName>KIRMED INTERNATIONAL SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000035071</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12010801</emdnCode>
    <emdnDescription>ULTRASONIC SCALPEL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K0770-1</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:37:35.862Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975070992590</udiDi>
    <basicUdiDi>697507099DUS00ND</basicUdiDi>
    <tradeName>Disposable Ultrasonic Scalpel</tradeName>
    <deviceName>Disposable Ultrasonic Scalpel</deviceName>
    <manufacturerName>Shenzhen Edge Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000039045</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12010801</emdnCode>
    <emdnDescription>ULTRASONIC SCALPEL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MP1500</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T15:04:32.599Z</lastUpdated>
  </row>
  <row>
    <udiDi>06979066040012</udiDi>
    <basicUdiDi>697471025K600ED</basicUdiDi>
    <tradeName>Miconvey</tradeName>
    <deviceName>Ultrasonic Surgical Generator</deviceName>
    <manufacturerName>Miconvey Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000031532</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12010801</emdnCode>
    <emdnDescription>ULTRASONIC SCALPEL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K600</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:20:33.218Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974710250939</udiDi>
    <basicUdiDi>697471025QUHP35RQ</basicUdiDi>
    <tradeName>Miconvey</tradeName>
    <deviceName>Ultrasonic Surgical Handpiece</deviceName>
    <manufacturerName>Miconvey Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000031532</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12010801</emdnCode>
    <emdnDescription>ULTRASONIC SCALPEL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>QUHP35</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:17:24.095Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974710250915</udiDi>
    <basicUdiDi>697471025K500E8</basicUdiDi>
    <tradeName>Miconvey</tradeName>
    <deviceName>Ultrasonic Surgical Generator</deviceName>
    <manufacturerName>Miconvey Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000031532</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12010801</emdnCode>
    <emdnDescription>ULTRASONIC SCALPEL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K500</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:17:21.692Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974710250144</udiDi>
    <basicUdiDi>697471025QUBP55QL</basicUdiDi>
    <tradeName>Miconvey</tradeName>
    <deviceName>Ultrasonic Surgical Handpiece</deviceName>
    <manufacturerName>Miconvey Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000031532</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12010801</emdnCode>
    <emdnDescription>ULTRASONIC SCALPEL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>QUBP55</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:17:20.106Z</lastUpdated>
  </row>
</eudamedExport>