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    <tradeName>06937893900633</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Tonglu Qianyan Medtech Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017342</manufacturerSrn>
    <authorisedRepresentativeName>Eunitor GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005081</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>K02010199</emdnCode>
    <emdnDescription>MONO- AND BIPOLAR INSTRUMENTS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F00015</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-18T10:58:58.487Z</lastUpdated>
  </row>
  <row>
    <udiDi>06937893900640</udiDi>
    <basicUdiDi>69378939F005S</basicUdiDi>
    <tradeName>06937893900640</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Tonglu Qianyan Medtech Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017342</manufacturerSrn>
    <authorisedRepresentativeName>Eunitor GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005081</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>K02010199</emdnCode>
    <emdnDescription>MONO- AND BIPOLAR INSTRUMENTS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F00027</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-18T10:58:58.461Z</lastUpdated>
  </row>
  <row>
    <udiDi>06937893900657</udiDi>
    <basicUdiDi>69378939F005S</basicUdiDi>
    <tradeName>06937893900657</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Tonglu Qianyan Medtech Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017342</manufacturerSrn>
    <authorisedRepresentativeName>Eunitor GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005081</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>K02010199</emdnCode>
    <emdnDescription>MONO- AND BIPOLAR INSTRUMENTS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F00031</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-18T10:58:58.442Z</lastUpdated>
  </row>
  <row>
    <udiDi>06937893903238</udiDi>
    <basicUdiDi>69378939F005S</basicUdiDi>
    <tradeName>06937893903238</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Tonglu Qianyan Medtech Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017342</manufacturerSrn>
    <authorisedRepresentativeName>Eunitor GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005081</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>K02010199</emdnCode>
    <emdnDescription>MONO- AND BIPOLAR INSTRUMENTS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F00016</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-18T10:58:58.187Z</lastUpdated>
  </row>
  <row>
    <udiDi>06937893903382</udiDi>
    <basicUdiDi>69378939F005S</basicUdiDi>
    <tradeName>06937893903382</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Tonglu Qianyan Medtech Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017342</manufacturerSrn>
    <authorisedRepresentativeName>Eunitor GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005081</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>K02010199</emdnCode>
    <emdnDescription>MONO- AND BIPOLAR INSTRUMENTS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F00008</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-18T10:58:58.141Z</lastUpdated>
  </row>
  <row>
    <udiDi>06937893904433</udiDi>
    <basicUdiDi>69378939F005S</basicUdiDi>
    <tradeName>06937893904433</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Tonglu Qianyan Medtech Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017342</manufacturerSrn>
    <authorisedRepresentativeName>Eunitor GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005081</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>K02010199</emdnCode>
    <emdnDescription>MONO- AND BIPOLAR INSTRUMENTS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F00010</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-18T10:58:58.096Z</lastUpdated>
  </row>
  <row>
    <udiDi>06937893904556</udiDi>
    <basicUdiDi>69378939F005S</basicUdiDi>
    <tradeName>06937893904556</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Tonglu Qianyan Medtech Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017342</manufacturerSrn>
    <authorisedRepresentativeName>Eunitor GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005081</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>K02010199</emdnCode>
    <emdnDescription>MONO- AND BIPOLAR INSTRUMENTS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F00018</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-18T10:58:58.068Z</lastUpdated>
  </row>
  <row>
    <udiDi>06937893904587</udiDi>
    <basicUdiDi>69378939F005S</basicUdiDi>
    <tradeName>06937893904587</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Tonglu Qianyan Medtech Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017342</manufacturerSrn>
    <authorisedRepresentativeName>Eunitor GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005081</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>K02010199</emdnCode>
    <emdnDescription>MONO- AND BIPOLAR INSTRUMENTS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F00020</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-18T10:58:58.044Z</lastUpdated>
  </row>
  <row>
    <udiDi>06937893904778</udiDi>
    <basicUdiDi>69378939F005S</basicUdiDi>
    <tradeName>06937893904778</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Tonglu Qianyan Medtech Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017342</manufacturerSrn>
    <authorisedRepresentativeName>Eunitor GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005081</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>K02010199</emdnCode>
    <emdnDescription>MONO- AND BIPOLAR INSTRUMENTS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F00032</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-18T10:58:58.023Z</lastUpdated>
  </row>
  <row>
    <udiDi>08427734037591</udiDi>
    <basicUdiDi>69443013010000MW</basicUdiDi>
    <tradeName>BLAYCO</tradeName>
    <deviceName>Disposable Electrosurgical Active Electrodes</deviceName>
    <manufacturerName>Zhejiang Jinhua Huatong Medical Appliance Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000010166</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>K0201010301</emdnCode>
    <emdnDescription>OPEN ELECTROSURGERY ELECTRODES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MB-100/5</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T04:11:58.873Z</lastUpdated>
  </row>
  <row>
    <udiDi>08427734037584</udiDi>
    <basicUdiDi>69443013010000MW</basicUdiDi>
    <tradeName>BLAYCO</tradeName>
    <deviceName>Disposable Electrosurgical Active Electrodes</deviceName>
    <manufacturerName>Zhejiang Jinhua Huatong Medical Appliance Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000010166</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>K0201010301</emdnCode>
    <emdnDescription>OPEN ELECTROSURGERY ELECTRODES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MB-100</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T03:58:50.666Z</lastUpdated>
  </row>
  <row>
    <udiDi>08427734037539</udiDi>
    <basicUdiDi>69443013010000MW</basicUdiDi>
    <tradeName>BLAYCO</tradeName>
    <deviceName>Disposable Electrosurgical Active Electrodes</deviceName>
    <manufacturerName>Zhejiang Jinhua Huatong Medical Appliance Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000010166</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>K0201010301</emdnCode>
    <emdnDescription>OPEN ELECTROSURGERY ELECTRODES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MB-500</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T03:46:42.346Z</lastUpdated>
  </row>
  <row>
    <udiDi>08427734037522</udiDi>
    <basicUdiDi>69443013010000MW</basicUdiDi>
    <tradeName>BLAYCO</tradeName>
    <deviceName>Disposable Electrosurgical Active Electrodes</deviceName>
    <manufacturerName>Zhejiang Jinhua Huatong Medical Appliance Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000010166</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>K0201010301</emdnCode>
    <emdnDescription>OPEN ELECTROSURGERY ELECTRODES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MB-400</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T02:30:45.720Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697207869CP001FXJZ</udiDi>
    <basicUdiDi>B-697207869CP001FXJZ</basicUdiDi>
    <tradeName>Blayco</tradeName>
    <deviceName>Sterile Electrosurgical Pencils</deviceName>
    <manufacturerName>Changzhou Innovate Medical Instrument and Technology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000041599</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K0201010201</emdnCode>
    <emdnDescription>OPEN ELECTROSURGERY DISSECTORS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MB-100CH</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:01:30.380Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-506041845PMS6300NGFAZ</udiDi>
    <basicUdiDi>B-506041845PMS6300NGFAZ</basicUdiDi>
    <tradeName>SuperVac</tradeName>
    <deviceName>Single Use Smoke Evacuation Fingerswitches</deviceName>
    <manufacturerName>Prima Medical Ltd</manufacturerName>
    <manufacturerSrn>UK-MF-000045180</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K0201010501</emdnCode>
    <emdnDescription>OPEN ELECTROSURGERY HANDPIECES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PMS63XXX</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:19:05.292Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-5060418456979W8</udiDi>
    <basicUdiDi>B-5060418456979W8</basicUdiDi>
    <tradeName>Retract</tradeName>
    <deviceName>Single Use MicroDissection Handpiece</deviceName>
    <manufacturerName>Prima Medical Ltd</manufacturerName>
    <manufacturerSrn>UK-MF-000045180</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K0201010501</emdnCode>
    <emdnDescription>OPEN ELECTROSURGERY HANDPIECES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PMS8001</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:19:04.939Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-5060418455828VB</udiDi>
    <basicUdiDi>B-5060418455828VB</basicUdiDi>
    <tradeName>D-5060418455828VB</tradeName>
    <deviceName>Single Use Electrosurgical Electrodes</deviceName>
    <manufacturerName>Prima Medical Ltd</manufacturerName>
    <manufacturerSrn>UK-MF-000045180</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K0201010302</emdnCode>
    <emdnDescription>LAPAR AND THORACOSCOPIC ELECTROSURGERY ELECTRODES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PMS29XX, PMS395X, LESXXX, PMS17XX, PMS3XXX</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:19:01.101Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-5060418455132TX</udiDi>
    <basicUdiDi>B-5060418455132TX</basicUdiDi>
    <tradeName>D-5060418455132TX</tradeName>
    <deviceName>Single Use Fingerswitches</deviceName>
    <manufacturerName>Prima Medical Ltd</manufacturerName>
    <manufacturerSrn>UK-MF-000045180</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K0201010501</emdnCode>
    <emdnDescription>OPEN ELECTROSURGERY HANDPIECES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PMS25X</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:19:00.285Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-5060418454166U9</udiDi>
    <basicUdiDi>B-5060418454166U9</basicUdiDi>
    <tradeName>Cotswold Needles</tradeName>
    <deviceName>Single Use Micro Dissection Needles</deviceName>
    <manufacturerName>Prima Medical Ltd</manufacturerName>
    <manufacturerSrn>UK-MF-000045180</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K0201010301</emdnCode>
    <emdnDescription>OPEN ELECTROSURGERY ELECTRODES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PMS16XX</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:18:58.997Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-5060418450151SY</udiDi>
    <basicUdiDi>B-5060418450151SY</basicUdiDi>
    <tradeName>MacroSeal</tradeName>
    <deviceName>Single Use Monopolar Forceps</deviceName>
    <manufacturerName>Prima Medical Ltd</manufacturerName>
    <manufacturerSrn>UK-MF-000045180</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K0201010601</emdnCode>
    <emdnDescription>OPEN ELECTROSURGERY FORCEPS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MS8XXX</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:18:58.755Z</lastUpdated>
  </row>
</eudamedExport>