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<eudamedExport entity="devices">
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    <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>06953815802298</udiDi>
    <basicUdiDi>69538158F100PH</basicUdiDi>
    <tradeName>SOUND REACH CSUS8000 Generator</tradeName>
    <deviceName>Ultrasound Surgical Equipment, Accessories: Transducer of Ultrasound Surgical Equipment,Footswitch of Ultrasound Surgical Equipment</deviceName>
    <manufacturerName>Reach Surgical,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000011148</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</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>CSUS8000</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:23:59.191Z</lastUpdated>
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  <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>
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  <row>
    <udiDi>06930934713018</udiDi>
    <basicUdiDi>693093472b043G7</basicUdiDi>
    <tradeName>Irrigation sleeve</tradeName>
    <deviceName>Irrigation Sleeve</deviceName>
    <manufacturerName>Beijing Sonicmed Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021987</manufacturerSrn>
    <authorisedRepresentativeName>Llins Service &amp; Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000009077</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12010880</emdnCode>
    <emdnDescription>INSTRUMENTS FOR ULTRASONIC SURGERY - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AA3IS3</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:48:47.001Z</lastUpdated>
  </row>
  <row>
    <udiDi>06930934709226</udiDi>
    <basicUdiDi>693093472b041G3</basicUdiDi>
    <tradeName>Tip Wrench</tradeName>
    <deviceName>Tip Wrench</deviceName>
    <manufacturerName>Beijing Sonicmed Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021987</manufacturerSrn>
    <authorisedRepresentativeName>Llins Service &amp; Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000009077</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>GWT8</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:48:45.055Z</lastUpdated>
  </row>
  <row>
    <udiDi>06930934709004</udiDi>
    <basicUdiDi>693093472b040FZ</basicUdiDi>
    <tradeName>Foot-switch</tradeName>
    <deviceName>Foot-switch</deviceName>
    <manufacturerName>Beijing Sonicmed Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021987</manufacturerSrn>
    <authorisedRepresentativeName>Llins Service &amp; Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000009077</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>FSD</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:48:44.845Z</lastUpdated>
  </row>
  <row>
    <udiDi>06924857500008</udiDi>
    <basicUdiDi>69248575ultrasoundgel4G</basicUdiDi>
    <tradeName>06924857500008</tradeName>
    <deviceName>Medical ultrasound gel</deviceName>
    <manufacturerName>Dongguan Hongyuan Pharmaceutical Technology</manufacturerName>
    <manufacturerSrn>CN-MF-000054519</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12010885</emdnCode>
    <emdnDescription>INSTRUMENTS FOR ULTRASONIC SURGERY - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5g/tube</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:25:09.353Z</lastUpdated>
  </row>
  <row>
    <udiDi>06921435100018</udiDi>
    <basicUdiDi>69214351MUG01LR</basicUdiDi>
    <tradeName>06921435100018</tradeName>
    <deviceName>Medical ultrasound gel</deviceName>
    <manufacturerName>Foshan Pingchuang Medical Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000039000</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12010885</emdnCode>
    <emdnDescription>INSTRUMENTS FOR ULTRASONIC SURGERY - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5g</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:09:27.451Z</lastUpdated>
  </row>
  <row>
    <udiDi>05213013380242</udiDi>
    <basicUdiDi>521301338ULT-SOUND-SETRA</basicUdiDi>
    <tradeName>SM343</tradeName>
    <deviceName>ΣΕΤ ΑΚΡΟΥ ΥΠΕΡΗΧΩΝ</deviceName>
    <manufacturerName>ΜΕΝΤΙΓΟΥΕΙ ΕΙΣΑΓΩΓΗ &amp; ΕΜΠΟΡΙΑ ΙΑΤΡΙΚΩΝ ΝΟΣΟΚΟΜΕΙΟΑΚΩΝ ΜΗΧΑΝΗΜΑΤΩΝ Μ. Ε.Π.Ε.</manufacturerName>
    <manufacturerSrn>GR-PR-000020404</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12010885</emdnCode>
    <emdnDescription>INSTRUMENTS FOR ULTRASONIC SURGERY - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SM343</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T06:46:39.333Z</lastUpdated>
  </row>
  <row>
    <udiDi>05051968022981</udiDi>
    <basicUdiDi>5060693520464WM</basicUdiDi>
    <tradeName>DOPPLEX</tradeName>
    <deviceName>3 WAY IEC PATIENT CABLE</deviceName>
    <manufacturerName>ArjoHuntleigh AB</manufacturerName>
    <manufacturerSrn>SE-MF-000000696</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>PA8-HG</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T06:00:59.191Z</lastUpdated>
  </row>
  <row>
    <udiDi>07613252031352</udiDi>
    <basicUdiDi>08858250000639SC</basicUdiDi>
    <tradeName>Sonopet</tradeName>
    <deviceName>Transport Carts</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>5450-850-410</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-30T19:47:41.968Z</lastUpdated>
  </row>
  <row>
    <udiDi>06953815802304</udiDi>
    <basicUdiDi>69538158F100PH</basicUdiDi>
    <tradeName>SOUND REACH FSW Footswitch</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Reach Surgical,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000011148</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12010880</emdnCode>
    <emdnDescription>INSTRUMENTS FOR ULTRASONIC SURGERY - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FSW2</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T02:19:07.815Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952471115391</udiDi>
    <basicUdiDi>69524711UTG00005U6</basicUdiDi>
    <tradeName>06952471115391</tradeName>
    <deviceName>Ultrasound Transmission Gel</deviceName>
    <manufacturerName>Anji Sunlight Medical Products Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014577</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12010885</emdnCode>
    <emdnDescription>INSTRUMENTS FOR ULTRASONIC SURGERY - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>250g/Bottle</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-29T06:44:02.583Z</lastUpdated>
  </row>
  <row>
    <udiDi>10857156006144</udiDi>
    <basicUdiDi>B-10857156006144</basicUdiDi>
    <tradeName>Tenex Health TX System</tradeName>
    <deviceName>TX2 Procedure Pack</deviceName>
    <manufacturerName>Tenex Health, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000034123</manufacturerSrn>
    <authorisedRepresentativeName>Donawa Lifescience Consulting Srl</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007785</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12010885</emdnCode>
    <emdnDescription>INSTRUMENTS FOR ULTRASONIC SURGERY - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>554-2003-002</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-23T03:57:22.444Z</lastUpdated>
  </row>
  <row>
    <udiDi>10857156006076</udiDi>
    <basicUdiDi>B-10857156006076</basicUdiDi>
    <tradeName>Tenex Health TX System</tradeName>
    <deviceName>TXB Procedure Pack</deviceName>
    <manufacturerName>Tenex Health, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000034123</manufacturerSrn>
    <authorisedRepresentativeName>Donawa Lifescience Consulting Srl</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007785</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12010885</emdnCode>
    <emdnDescription>INSTRUMENTS FOR ULTRASONIC SURGERY - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>554-3003-002</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-23T03:57:21.642Z</lastUpdated>
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    <udiDi>00821925039445</udiDi>
    <basicUdiDi>08219250000155</basicUdiDi>
    <tradeName>00821925039445</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-W</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-23T03:53:29.296Z</lastUpdated>
  </row>
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    <udiDi>00821925043671</udiDi>
    <basicUdiDi>08219250000155</basicUdiDi>
    <tradeName>00821925043671</tradeName>
    <deviceName></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-CSL</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T03:49:19.920Z</lastUpdated>
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    <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>
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  <row>
    <udiDi>10857156006205</udiDi>
    <basicUdiDi>B-10857156006205</basicUdiDi>
    <tradeName>Tenex Health TX System</tradeName>
    <deviceName>TX1 Procedure Pack</deviceName>
    <manufacturerName>Tenex Health, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000034123</manufacturerSrn>
    <authorisedRepresentativeName>Donawa Lifescience Consulting Srl</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007785</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12010885</emdnCode>
    <emdnDescription>INSTRUMENTS FOR ULTRASONIC SURGERY - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>554-1003-002</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-22T19:50:01.479Z</lastUpdated>
  </row>
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    <udiDi>00857156006307</udiDi>
    <basicUdiDi>B-00857156006307</basicUdiDi>
    <tradeName>Tenex Health TX System</tradeName>
    <deviceName>Tenex Health TX System Console</deviceName>
    <manufacturerName>Tenex Health, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000034123</manufacturerSrn>
    <authorisedRepresentativeName>Donawa Lifescience Consulting Srl</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007785</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12010880</emdnCode>
    <emdnDescription>INSTRUMENTS FOR ULTRASONIC SURGERY - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>554-0000-000</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-22T19:48:16.587Z</lastUpdated>
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