<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06970950282532</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>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-30T07:48:32.248Z</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>
  <row>
    <udiDi>06970950280750</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-S-C</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T07:47:38.224Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970950280743</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-L-C</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T07:47:37.035Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970950280699</udiDi>
    <basicUdiDi>6970950282b010AT</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>K0202010101</emdnCode>
    <emdnDescription>ULTRASONIC OPEN SURGERY SCISSORS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AH-637-9</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T07:47:35.830Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970950280682</udiDi>
    <basicUdiDi>6970950282b001AS</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-639-T-C</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T07:47:29.819Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970950280675</udiDi>
    <basicUdiDi>6970950282b001AS</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-639-O-C</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T07:47:28.638Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970950280668</udiDi>
    <basicUdiDi>6970950282b001AS</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-639-S-C</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T07:47:27.425Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970950280651</udiDi>
    <basicUdiDi>6970950282b001AS</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-639-L-C</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T07:47:26.225Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970950280644</udiDi>
    <basicUdiDi>6970950282b007B6</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-639-T</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T07:47:20.219Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970950280637</udiDi>
    <basicUdiDi>6970950282b007B6</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-639-O</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T07:47:19.018Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970950280620</udiDi>
    <basicUdiDi>6970950282b007B6</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-639-S</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T07:47:17.810Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970950280613</udiDi>
    <basicUdiDi>6970950282b007B6</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-639-L</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T07:47:16.612Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970950280187</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-S</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T07:47:10.609Z</lastUpdated>
  </row>
  <row>
    <udiDi>06903053078276</udiDi>
    <basicUdiDi>69449040AB051100035Y</basicUdiDi>
    <tradeName>06903053078276</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>K0202010201</emdnCode>
    <emdnDescription>ULTRASONIC OPEN SURGERY HANDPIECES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>POS-23</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T11:11:12.481Z</lastUpdated>
  </row>
  <row>
    <udiDi>06903053078283</udiDi>
    <basicUdiDi>69449040AB051100035Y</basicUdiDi>
    <tradeName>06903053078283</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>K0202010201</emdnCode>
    <emdnDescription>ULTRASONIC OPEN SURGERY HANDPIECES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FOK-14</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T11:11:12.461Z</lastUpdated>
  </row>
  <row>
    <udiDi>06903053078290</udiDi>
    <basicUdiDi>69449040AB051100035Y</basicUdiDi>
    <tradeName>06903053078290</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>K0202010201</emdnCode>
    <emdnDescription>ULTRASONIC OPEN SURGERY HANDPIECES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FOS-45</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T11:11:12.440Z</lastUpdated>
  </row>
  <row>
    <udiDi>06903053078306</udiDi>
    <basicUdiDi>69449040AB051100035Y</basicUdiDi>
    <tradeName>06903053078306</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>K0202010201</emdnCode>
    <emdnDescription>ULTRASONIC OPEN SURGERY HANDPIECES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FOM-14</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T11:11:12.425Z</lastUpdated>
  </row>
  <row>
    <udiDi>06903053078313</udiDi>
    <basicUdiDi>69449040AB051100035Y</basicUdiDi>
    <tradeName>06903053078313</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>K0202010201</emdnCode>
    <emdnDescription>ULTRASONIC OPEN SURGERY HANDPIECES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>POM-45</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T11:11:12.410Z</lastUpdated>
  </row>
</eudamedExport>