<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06973118370072</udiDi>
    <basicUdiDi>B-06973118370072</basicUdiDi>
    <tradeName>06973118370072</tradeName>
    <deviceName>Disposable Fascial Closure Systems</deviceName>
    <manufacturerName>ChangZhou 3R Medical Device Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001123</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K01020116</emdnCode>
    <emdnDescription>ENDOSCOPIC TISSUE SUTURE APPROXIMATORS, SINGLE - USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SRDFCS-B-20</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T13:29:22.441Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973118370065</udiDi>
    <basicUdiDi>B-06973118370065</basicUdiDi>
    <tradeName>06973118370065</tradeName>
    <deviceName>Disposable Fascial Closure Systems</deviceName>
    <manufacturerName>ChangZhou 3R Medical Device Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001123</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K01020116</emdnCode>
    <emdnDescription>ENDOSCOPIC TISSUE SUTURE APPROXIMATORS, SINGLE - USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SRDFCS-B-15</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T13:29:21.637Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973118370058</udiDi>
    <basicUdiDi>B-06973118370058</basicUdiDi>
    <tradeName>06973118370058</tradeName>
    <deviceName>Disposable Fascial Closure Systems</deviceName>
    <manufacturerName>ChangZhou 3R Medical Device Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001123</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K01020116</emdnCode>
    <emdnDescription>ENDOSCOPIC TISSUE SUTURE APPROXIMATORS, SINGLE - USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SRDFCS-B-12</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T13:29:20.860Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973118370041</udiDi>
    <basicUdiDi>B-06973118370041</basicUdiDi>
    <tradeName>06973118370041</tradeName>
    <deviceName>Disposable Fascial Closure Systems</deviceName>
    <manufacturerName>ChangZhou 3R Medical Device Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001123</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K01020116</emdnCode>
    <emdnDescription>ENDOSCOPIC TISSUE SUTURE APPROXIMATORS, SINGLE - USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SRDFCS-B-10</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T13:29:16.834Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973118370027</udiDi>
    <basicUdiDi>B-06973118370027</basicUdiDi>
    <tradeName>06973118370027</tradeName>
    <deviceName>Disposable Fascial Closure Systems</deviceName>
    <manufacturerName>ChangZhou 3R Medical Device Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001123</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K01020116</emdnCode>
    <emdnDescription>ENDOSCOPIC TISSUE SUTURE APPROXIMATORS, SINGLE - USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SRDFCS-A-15</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T13:29:16.051Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973118370010</udiDi>
    <basicUdiDi>B-06973118370010</basicUdiDi>
    <tradeName>06973118370010</tradeName>
    <deviceName>Disposable Fascial Closure Systems</deviceName>
    <manufacturerName>ChangZhou 3R Medical Device Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001123</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K01020116</emdnCode>
    <emdnDescription>ENDOSCOPIC TISSUE SUTURE APPROXIMATORS, SINGLE - USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SRDFCS-A-12</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T13:29:15.242Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973118370034</udiDi>
    <basicUdiDi>B-06973118370034</basicUdiDi>
    <tradeName>06973118370034</tradeName>
    <deviceName>Disposable Fascial Closure Systems</deviceName>
    <manufacturerName>ChangZhou 3R Medical Device Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001123</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K01020116</emdnCode>
    <emdnDescription>ENDOSCOPIC TISSUE SUTURE APPROXIMATORS, SINGLE - USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SRDFCS-A-20</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T13:29:14.432Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973118370003</udiDi>
    <basicUdiDi>B-06973118370003</basicUdiDi>
    <tradeName>06973118370003</tradeName>
    <deviceName>Disposable Fascial Closure Systems</deviceName>
    <manufacturerName>ChangZhou 3R Medical Device Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001123</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K01020116</emdnCode>
    <emdnDescription>ENDOSCOPIC TISSUE SUTURE APPROXIMATORS, SINGLE - USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SRDFCS-A-10</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T13:29:10.559Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971254928287</udiDi>
    <basicUdiDi>B-06971254928287</basicUdiDi>
    <tradeName>PORT CLOSURE DEVICE</tradeName>
    <deviceName>PORT CLOSURE DEVICE</deviceName>
    <manufacturerName>VHMED (Nantong) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000016558</manufacturerSrn>
    <authorisedRepresentativeName>Very Heal Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000037579</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K01020116</emdnCode>
    <emdnDescription>ENDOSCOPIC TISSUE SUTURE APPROXIMATORS, SINGLE - USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CL418</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:50:14.767Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971254928270</udiDi>
    <basicUdiDi>B-06971254928270</basicUdiDi>
    <tradeName>PORT CLOSURE DEVICE</tradeName>
    <deviceName>PORT CLOSURE DEVICE</deviceName>
    <manufacturerName>VHMED (Nantong) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000016558</manufacturerSrn>
    <authorisedRepresentativeName>Very Heal Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000037579</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K01020116</emdnCode>
    <emdnDescription>ENDOSCOPIC TISSUE SUTURE APPROXIMATORS, SINGLE - USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CL417</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:50:13.973Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971254928263</udiDi>
    <basicUdiDi>B-06971254928263</basicUdiDi>
    <tradeName>PORT CLOSURE DEVICE</tradeName>
    <deviceName>PORT CLOSURE DEVICE</deviceName>
    <manufacturerName>VHMED (Nantong) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000016558</manufacturerSrn>
    <authorisedRepresentativeName>Very Heal Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000037579</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K01020116</emdnCode>
    <emdnDescription>ENDOSCOPIC TISSUE SUTURE APPROXIMATORS, SINGLE - USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CL416</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:50:12.357Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971254928256</udiDi>
    <basicUdiDi>B-06971254928256</basicUdiDi>
    <tradeName>PORT CLOSURE DEVICE</tradeName>
    <deviceName>PORT CLOSURE DEVICE</deviceName>
    <manufacturerName>VHMED (Nantong) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000016558</manufacturerSrn>
    <authorisedRepresentativeName>Very Heal Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000037579</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K01020116</emdnCode>
    <emdnDescription>ENDOSCOPIC TISSUE SUTURE APPROXIMATORS, SINGLE - USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CL415</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:50:09.154Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971254928249</udiDi>
    <basicUdiDi>B-06971254928249</basicUdiDi>
    <tradeName>PORT CLOSURE DEVICE</tradeName>
    <deviceName>PORT CLOSURE DEVICE</deviceName>
    <manufacturerName>VHMED (Nantong) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000016558</manufacturerSrn>
    <authorisedRepresentativeName>Very Heal Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000037579</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K01020116</emdnCode>
    <emdnDescription>ENDOSCOPIC TISSUE SUTURE APPROXIMATORS, SINGLE - USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CL414</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:50:07.901Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971254928232</udiDi>
    <basicUdiDi>B-06971254928232</basicUdiDi>
    <tradeName>PORT CLOSURE DEVICE</tradeName>
    <deviceName>PORT CLOSURE DEVICE</deviceName>
    <manufacturerName>VHMED (Nantong) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000016558</manufacturerSrn>
    <authorisedRepresentativeName>Very Heal Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000037579</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K01020116</emdnCode>
    <emdnDescription>ENDOSCOPIC TISSUE SUTURE APPROXIMATORS, SINGLE - USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CL413</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:50:06.768Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971254928225</udiDi>
    <basicUdiDi>B-06971254928225</basicUdiDi>
    <tradeName>PORT CLOSURE DEVICE</tradeName>
    <deviceName>PORT CLOSURE DEVICE</deviceName>
    <manufacturerName>VHMED (Nantong) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000016558</manufacturerSrn>
    <authorisedRepresentativeName>Very Heal Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000037579</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K01020116</emdnCode>
    <emdnDescription>ENDOSCOPIC TISSUE SUTURE APPROXIMATORS, SINGLE - USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CL412</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:50:05.359Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971254928218</udiDi>
    <basicUdiDi>B-06971254928218</basicUdiDi>
    <tradeName>PORT CLOSURE DEVICE</tradeName>
    <deviceName>PORT CLOSURE DEVICE</deviceName>
    <manufacturerName>VHMED (Nantong) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000016558</manufacturerSrn>
    <authorisedRepresentativeName>Very Heal Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000037579</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K01020116</emdnCode>
    <emdnDescription>ENDOSCOPIC TISSUE SUTURE APPROXIMATORS, SINGLE - USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CL411</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:50:02.783Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971254927884</udiDi>
    <basicUdiDi>B-06971254927884</basicUdiDi>
    <tradeName>PORT CLOSURE DEVICE</tradeName>
    <deviceName>PORT CLOSURE DEVICE</deviceName>
    <manufacturerName>VHMED (Nantong) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000016558</manufacturerSrn>
    <authorisedRepresentativeName>Very Heal Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000037579</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K01020116</emdnCode>
    <emdnDescription>ENDOSCOPIC TISSUE SUTURE APPROXIMATORS, SINGLE - USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CL408</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:49:50.066Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971254927877</udiDi>
    <basicUdiDi>B-06971254927877</basicUdiDi>
    <tradeName>PORT CLOSURE DEVICE</tradeName>
    <deviceName>PORT CLOSURE DEVICE</deviceName>
    <manufacturerName>VHMED (Nantong) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000016558</manufacturerSrn>
    <authorisedRepresentativeName>Very Heal Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000037579</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K01020116</emdnCode>
    <emdnDescription>ENDOSCOPIC TISSUE SUTURE APPROXIMATORS, SINGLE - USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CL407</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:49:34.814Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971254927860</udiDi>
    <basicUdiDi>B-06971254927860</basicUdiDi>
    <tradeName>PORT CLOSURE DEVICE</tradeName>
    <deviceName>PORT CLOSURE DEVICE</deviceName>
    <manufacturerName>VHMED (Nantong) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000016558</manufacturerSrn>
    <authorisedRepresentativeName>Very Heal Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000037579</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K01020116</emdnCode>
    <emdnDescription>ENDOSCOPIC TISSUE SUTURE APPROXIMATORS, SINGLE - USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CL406</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:49:33.777Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971254927853</udiDi>
    <basicUdiDi>B-06971254927853</basicUdiDi>
    <tradeName>PORT CLOSURE DEVICE</tradeName>
    <deviceName>PORT CLOSURE DEVICE</deviceName>
    <manufacturerName>VHMED (Nantong) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000016558</manufacturerSrn>
    <authorisedRepresentativeName>Very Heal Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000037579</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K01020116</emdnCode>
    <emdnDescription>ENDOSCOPIC TISSUE SUTURE APPROXIMATORS, SINGLE - USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CL405</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:49:31.045Z</lastUpdated>
  </row>
</eudamedExport>