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<eudamedExport entity="devices">
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    <basicUdiDi>6970950282b009BA</basicUdiDi>
    <tradeName>Ultrasonic Surgical Shears</tradeName>
    <deviceName>Ultrasonic Surgical Shears</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>K0202010102</emdnCode>
    <emdnDescription>LAPAROSCOPIC AND THORACOSCOPIC ULTRASONIC SURGERY SCISSORS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AH-638-B-T</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-30T07:48:32.248Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970950282334</udiDi>
    <basicUdiDi>6970950282b014B3</basicUdiDi>
    <tradeName>06970950282334</tradeName>
    <deviceName>Electrosurgical Vessel Sealer/Divider</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>K0201010202</emdnCode>
    <emdnDescription>LAPAROSCOPIC AND THORACOSCOPIC ELECTROSURGERY DISSECTORS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AH-163XP-44S</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-30T07:48:31.047Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970950282327</udiDi>
    <basicUdiDi>6970950282b014B3</basicUdiDi>
    <tradeName>06970950282327</tradeName>
    <deviceName>Electrosurgical Vessel Sealer/Divider</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>K0201010201</emdnCode>
    <emdnDescription>OPEN ELECTROSURGERY DISSECTORS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AH-163XP-37S</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-30T07:48:29.854Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970950282310</udiDi>
    <basicUdiDi>6970950282b014B3</basicUdiDi>
    <tradeName>06970950282310</tradeName>
    <deviceName>Electrosurgical Vessel Sealer/Divider</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>K0201010202</emdnCode>
    <emdnDescription>LAPAROSCOPIC AND THORACOSCOPIC ELECTROSURGERY DISSECTORS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AH-163XP-23S</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-30T07:48:22.655Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970950282303</udiDi>
    <basicUdiDi>6970950282b014B3</basicUdiDi>
    <tradeName>06970950282303</tradeName>
    <deviceName>Electrosurgical Vessel Sealer/Divider</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>K0201010202</emdnCode>
    <emdnDescription>LAPAROSCOPIC AND THORACOSCOPIC ELECTROSURGERY DISSECTORS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AH-163XP-44L</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-30T07:48:21.445Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970950282297</udiDi>
    <basicUdiDi>6970950282b014B3</basicUdiDi>
    <tradeName>06970950282297</tradeName>
    <deviceName>Electrosurgical Vessel Sealer/Divider</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>K0201010202</emdnCode>
    <emdnDescription>LAPAROSCOPIC AND THORACOSCOPIC ELECTROSURGERY DISSECTORS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AH-163XP-37L</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-30T07:48:20.252Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970950282280</udiDi>
    <basicUdiDi>6970950282b014B3</basicUdiDi>
    <tradeName>06970950282280</tradeName>
    <deviceName>Electrosurgical Vessel Sealer/Divider</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>K0201010201</emdnCode>
    <emdnDescription>OPEN ELECTROSURGERY DISSECTORS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AH-163XP-23L</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-30T07:48:19.043Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970950282273</udiDi>
    <basicUdiDi>6970950282b014B3</basicUdiDi>
    <tradeName>06970950282273</tradeName>
    <deviceName>Electrosurgical Vessel Sealer/Divider</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>K0201010201</emdnCode>
    <emdnDescription>OPEN ELECTROSURGERY DISSECTORS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AH-1637-21</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-30T07:48:11.849Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970950281696</udiDi>
    <basicUdiDi>6970950282b016B7</basicUdiDi>
    <tradeName>06970950281696</tradeName>
    <deviceName>Ultrasonic &amp; Electrosurgical Shears</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>K0299</emdnCode>
    <emdnDescription>ELECTROSURGERY DEVICES, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AH-1851-S</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-30T07:48:10.645Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970950281689</udiDi>
    <basicUdiDi>6970950282b016B7</basicUdiDi>
    <tradeName>06970950281689</tradeName>
    <deviceName>Ultrasonic &amp; Electrosurgical Shears</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>K0299</emdnCode>
    <emdnDescription>ELECTROSURGERY DEVICES, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AH-1851-L,</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-30T07:48:09.468Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970950281672</udiDi>
    <basicUdiDi>6970950282b019BD</basicUdiDi>
    <tradeName>06970950281672</tradeName>
    <deviceName>Ultrasonic &amp; Electrosurgical System Handpiece</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>L180302</emdnCode>
    <emdnDescription>ENDOSCOPIC ELECTROSURGERY HANDPIECES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AH-1850</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-30T07:48:08.245Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970950281658</udiDi>
    <basicUdiDi>6970950282b015B5</basicUdiDi>
    <tradeName>06970950281658</tradeName>
    <deviceName>Ultrasonic &amp; Electrosurgical 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>Z12010902</emdnCode>
    <emdnDescription>ELECTROSURGICAL UNITS (ESU) FOR GENERAL USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AH-1811</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-30T07:48:02.353Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970950281610</udiDi>
    <basicUdiDi>6970950282b014B3</basicUdiDi>
    <tradeName>06970950281610</tradeName>
    <deviceName>Electrosurgical Vessel Sealer/Divider</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>K0201010201</emdnCode>
    <emdnDescription>OPEN ELECTROSURGERY DISSECTORS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AH-16319-44</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-30T07:47:59.832Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970950281603</udiDi>
    <basicUdiDi>6970950282b014B3</basicUdiDi>
    <tradeName>06970950281603</tradeName>
    <deviceName>Electrosurgical Vessel Sealer/Divider</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>K0201010101</emdnCode>
    <emdnDescription>OPEN ELECTROSURGERY MULTIFUNCTIONAL CANNULAS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AH-16319-37</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-30T07:47:58.658Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970950281597</udiDi>
    <basicUdiDi>6970950282b014B3</basicUdiDi>
    <tradeName>06970950281597</tradeName>
    <deviceName>Electrosurgical Vessel Sealer/Divider</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>K0201010202</emdnCode>
    <emdnDescription>LAPAROSCOPIC AND THORACOSCOPIC ELECTROSURGERY DISSECTORS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AH-16319-23</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-30T07:47:57.440Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970950281573</udiDi>
    <basicUdiDi>6970950282b013AZ</basicUdiDi>
    <tradeName>06970950281573</tradeName>
    <deviceName>AH-1610 Ultrasonic &amp; Electrosurgical System</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>K0201010201</emdnCode>
    <emdnDescription>OPEN ELECTROSURGERY DISSECTORS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AH-1611</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-30T07:47:50.246Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970950281566</udiDi>
    <basicUdiDi>6970950282b013AZ</basicUdiDi>
    <tradeName>06970950281566</tradeName>
    <deviceName>AH-1610 Ultrasonic &amp; Electrosurgical System</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-1610</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-30T07:47:49.032Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970950281351</udiDi>
    <basicUdiDi>6970950282b009BA</basicUdiDi>
    <tradeName>Ultrasonic Surgical Shears</tradeName>
    <deviceName>Ultrasonic Surgical Shears</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>K0202010102</emdnCode>
    <emdnDescription>LAPAROSCOPIC AND THORACOSCOPIC ULTRASONIC SURGERY SCISSORS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AH-638-B-T</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T07:47:47.835Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970950280774</udiDi>
    <basicUdiDi>6970950282b006B4</basicUdiDi>
    <tradeName>Ultrasonic Surgical Shears</tradeName>
    <deviceName>Ultrasonic Surgical Shears</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>K0202010102</emdnCode>
    <emdnDescription>LAPAROSCOPIC AND THORACOSCOPIC ULTRASONIC SURGERY SCISSORS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AH-638-B-T-C</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T07:47:46.643Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970950280767</udiDi>
    <basicUdiDi>6970950282b006B4</basicUdiDi>
    <tradeName>Ultrasonic Surgical Shears</tradeName>
    <deviceName>Ultrasonic Surgical Shears</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>K0202010102</emdnCode>
    <emdnDescription>LAPAROSCOPIC AND THORACOSCOPIC ULTRASONIC SURGERY SCISSORS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AH-638-B-O-C</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T07:47:39.437Z</lastUpdated>
  </row>
</eudamedExport>