<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06971449611161</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-3S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:49:00.964Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971449611260</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-0206P-20</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:49:00.936Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971449611277</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-0506P-20</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:49:00.925Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971449611284</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-0606P-20</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:49:00.913Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971449611291</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-0706P-20</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:49:00.899Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971449611307</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-1102P-20</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:49:00.888Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971449611321</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-0106P-20</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:49:00.854Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971449611338</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-0206P-20</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:49:00.841Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971449611345</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-0506P-20</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:49:00.826Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971449611352</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-0606P-20</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:49:00.809Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971449611369</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-0706P-20</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:49:00.787Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971449611376</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-0902P-20</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:49:00.765Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971449611383</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-1202P-20</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:49:00.747Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971449611390</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-1302P-20</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:49:00.724Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971449611406</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-1002P-20</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:49:00.705Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971449611710</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-9092-500</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:49:00.673Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971449611727</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-9092-300</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:49:00.651Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971449611734</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-9093-500</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:49:00.636Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971449611741</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-9093-300</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:49:00.618Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971449611758</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>6Fr</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:49:00.602Z</lastUpdated>
  </row>
</eudamedExport>