<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06971449612045</udiDi>
    <basicUdiDi>697144961GSLTT</basicUdiDi>
    <tradeName>ANAESTHETIC GAS SAMPLING LINE</tradeName>
    <deviceName>ANAESTHETIC GAS SAMPLING LINE</deviceName>
    <manufacturerName>Shenzhen Envisen Industry Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010838</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R9099</emdnCode>
    <emdnDescription>RESPIRATORY AND ANAESTHESIA DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>QPS8003</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T08:58:57.788Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971449611956</udiDi>
    <basicUdiDi>697144961NIBPRSSR</basicUdiDi>
    <tradeName>NIBP Cuff</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Envisen Industry Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010838</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1203020285</emdnCode>
    <emdnDescription>MULTI-PARAMETER MONITORS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NRS-1102-30</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T08:58:56.979Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971449611703</udiDi>
    <basicUdiDi>697144961ECTSH</basicUdiDi>
    <tradeName>Medical Cable Assemblies</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Envisen Industry Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010838</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1203020299</emdnCode>
    <emdnDescription>MULTI–PARAMETER MONITORS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XT-11494-300</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T08:58:52.991Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971449611314</udiDi>
    <basicUdiDi>697144961NIBPDSRF</basicUdiDi>
    <tradeName>NIBP Cuff</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Envisen Industry Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010838</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1203020285</emdnCode>
    <emdnDescription>MULTI-PARAMETER MONITORS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NDS-1102P-20</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T08:58:52.181Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971449611253</udiDi>
    <basicUdiDi>697144961NIBPDDQH</basicUdiDi>
    <tradeName>NIBP Cuff</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Envisen Industry Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010838</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1203020285</emdnCode>
    <emdnDescription>MULTI-PARAMETER MONITORS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NDD-0106P-20</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T08:58:51.393Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971449610591</udiDi>
    <basicUdiDi>697144961HPDT7</basicUdiDi>
    <tradeName>Head Positioning Device</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Envisen Industry Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010838</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y121821</emdnCode>
    <emdnDescription>RETRACTORS, BACKRESTS, BRACKETS AND SUPPORTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>QPHPD</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T08:58:50.586Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971449610362</udiDi>
    <basicUdiDi>697144961DTPTP</basicUdiDi>
    <tradeName>Disposable Temperature Probe</tradeName>
    <deviceName>Disposable Temperature Probe</deviceName>
    <manufacturerName>Shenzhen Envisen Industry Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010838</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V03010299</emdnCode>
    <emdnDescription>BODY TEMPERATURE MONITORING PROBES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TGM-1691-75</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-02T08:58:35.317Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971449610249</udiDi>
    <basicUdiDi>697144961TFCU3</basicUdiDi>
    <tradeName>Sterile Foley Catheter With Temperature Probe</tradeName>
    <deviceName>Sterile Foley Catheter With Temperature Probe</deviceName>
    <manufacturerName>Shenzhen Envisen Industry Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010838</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U0103</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS WITH TEMPERATURE SENSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8Fr</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T08:58:34.513Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971449610256</udiDi>
    <basicUdiDi>697144961TFCU3</basicUdiDi>
    <tradeName>Sterile Foley Catheter With Temperature Probe</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Envisen Industry Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010838</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U0103</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS WITH TEMPERATURE SENSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10Fr</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:49:01.152Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971449610263</udiDi>
    <basicUdiDi>697144961TFCU3</basicUdiDi>
    <tradeName>Sterile Foley Catheter With Temperature Probe</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Envisen Industry Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010838</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U0103</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS WITH TEMPERATURE SENSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>12Fr</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:49:01.138Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971449610270</udiDi>
    <basicUdiDi>697144961TFCU3</basicUdiDi>
    <tradeName>Sterile Foley Catheter With Temperature Probe</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Envisen Industry Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010838</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U0103</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS WITH TEMPERATURE SENSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>14Fr</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:49:01.125Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971449610287</udiDi>
    <basicUdiDi>697144961TFCU3</basicUdiDi>
    <tradeName>Sterile Foley Catheter With Temperature Probe</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Envisen Industry Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010838</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U0103</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS WITH TEMPERATURE SENSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>16Fr</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:49:01.110Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971449610294</udiDi>
    <basicUdiDi>697144961TFCU3</basicUdiDi>
    <tradeName>Sterile Foley Catheter With Temperature Probe</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Envisen Industry Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010838</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U0103</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS WITH TEMPERATURE SENSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18Fr</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:49:01.097Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971449610300</udiDi>
    <basicUdiDi>697144961TFCU3</basicUdiDi>
    <tradeName>Sterile Foley Catheter With Temperature Probe</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Envisen Industry Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010838</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U0103</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS WITH TEMPERATURE SENSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20Fr</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:49:01.083Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971449610324</udiDi>
    <basicUdiDi>697144961TFCU3</basicUdiDi>
    <tradeName>Sterile Foley Catheter With Temperature Probe</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Envisen Industry Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010838</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U0103</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS WITH TEMPERATURE SENSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>22Fr</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:49:01.071Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971449610331</udiDi>
    <basicUdiDi>697144961TFCU3</basicUdiDi>
    <tradeName>Sterile Foley Catheter With Temperature Probe</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Envisen Industry Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010838</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U0103</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS WITH TEMPERATURE SENSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>24Fr</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:49:01.061Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971449610614</udiDi>
    <basicUdiDi>697144961HPDT7</basicUdiDi>
    <tradeName>Head Positioning Device</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Envisen Industry Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010838</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y121821</emdnCode>
    <emdnDescription>RETRACTORS, BACKRESTS, BRACKETS AND SUPPORTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>QView-P</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:49:01.019Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971449610690</udiDi>
    <basicUdiDi>697144961HPDT7</basicUdiDi>
    <tradeName>Head Positioning Device</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Envisen Industry Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010838</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y121821</emdnCode>
    <emdnDescription>RETRACTORS, BACKRESTS, BRACKETS AND SUPPORTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>QView-JS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:49:01.005Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971449610959</udiDi>
    <basicUdiDi>697144961HPDT7</basicUdiDi>
    <tradeName>Head Positioning Device</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Envisen Industry Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010838</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y121821</emdnCode>
    <emdnDescription>RETRACTORS, BACKRESTS, BRACKETS AND SUPPORTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>QView-3</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:49:00.993Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971449611154</udiDi>
    <basicUdiDi>697144961HPDT7</basicUdiDi>
    <tradeName>Head Positioning Device</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Envisen Industry Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010838</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y121821</emdnCode>
    <emdnDescription>RETRACTORS, BACKRESTS, BRACKETS AND SUPPORTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>QView-PS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:49:00.980Z</lastUpdated>
  </row>
</eudamedExport>