<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08905080006275</udiDi>
    <basicUdiDi>8905080BUSH7E</basicUdiDi>
    <tradeName>P Flex Ureteral Stent Set Both Ends Open with String &amp; Hydrophilic Coating</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Blue Neem Medical Devices Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000021793</manufacturerSrn>
    <authorisedRepresentativeName>Arazy Group (Ireland) Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000093</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BEUSB00801231</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T19:48:27.275Z</lastUpdated>
  </row>
  <row>
    <udiDi>04580708066691</udiDi>
    <basicUdiDi>4571225300011U9</basicUdiDi>
    <tradeName>TSK SELECT NEEDLE</tradeName>
    <deviceName></deviceName>
    <manufacturerName>TSK Laboratory, Japan</manufacturerName>
    <manufacturerSrn>JP-MF-000008485</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TSN-050013</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T19:48:27.259Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800208642031</udiDi>
    <basicUdiDi>88002086IFS18HG</basicUdiDi>
    <tradeName>JUST Implant System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>KJ MEDITECH Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000039683</manufacturerSrn>
    <authorisedRepresentativeName>S.B. Pharma GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005392</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LAOR50</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T19:48:27.243Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290108813913</udiDi>
    <basicUdiDi>B-07290108813913</basicUdiDi>
    <tradeName>Ball Attachment  Ti.</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NORIS MEDICAL Ltd</manufacturerName>
    <manufacturerSrn>IL-MF-000008710</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NM-T1205</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T19:48:27.230Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800208636412</udiDi>
    <basicUdiDi>88002086IFS18HG</basicUdiDi>
    <tradeName>JUST Implant System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>KJ MEDITECH Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000039683</manufacturerSrn>
    <authorisedRepresentativeName>S.B. Pharma GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005392</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LAOR70</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T19:48:27.213Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972992510949</udiDi>
    <basicUdiDi>697299251DUDBRN</basicUdiDi>
    <tradeName>Disposable Urinary Drainage  Bag</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Changzhou CareU Medical Instruments Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027623</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CU-BF-A-800ml</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T19:48:27.202Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800208636344</udiDi>
    <basicUdiDi>88002086IFS18HG</basicUdiDi>
    <tradeName>JUST Implant System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>KJ MEDITECH Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000039683</manufacturerSrn>
    <authorisedRepresentativeName>S.B. Pharma GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005392</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LAN</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T19:48:27.188Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260539181892</udiDi>
    <basicUdiDi>426053918UPASCNGK</basicUdiDi>
    <tradeName>DeepFX MicroScanner</tradeName>
    <deviceName>Scanner</deviceName>
    <manufacturerName>Lumenis (Germany) GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000007655</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12011080</emdnCode>
    <emdnDescription>LASER SURGERY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AC-00013550GR</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T19:48:27.182Z</lastUpdated>
  </row>
  <row>
    <udiDi>+J021302890001</udiDi>
    <basicUdiDi>++J021S0006RC</basicUdiDi>
    <tradeName>SI-1015</tradeName>
    <deviceName></deviceName>
    <manufacturerName>W&amp;H Dentalwerk Bürmoos GmbH</manufacturerName>
    <manufacturerSrn>AT-MF-000001590</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30289000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T19:48:27.172Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972992510956</udiDi>
    <basicUdiDi>697299251DUDBRN</basicUdiDi>
    <tradeName>06972992510956</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Changzhou CareU Medical Instruments Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027623</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CU-BT-A-900ml</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T19:48:27.152Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290108813920</udiDi>
    <basicUdiDi>B-07290108813920</basicUdiDi>
    <tradeName>Ball Attachment  Ti.</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NORIS MEDICAL Ltd</manufacturerName>
    <manufacturerSrn>IL-MF-000008710</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NM-T1206</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T19:48:27.134Z</lastUpdated>
  </row>
  <row>
    <udiDi>04580708066011</udiDi>
    <basicUdiDi>4571225300011U9</basicUdiDi>
    <tradeName>TSK SELECT NEEDLE</tradeName>
    <deviceName></deviceName>
    <manufacturerName>TSK Laboratory, Japan</manufacturerName>
    <manufacturerSrn>JP-MF-000008485</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TSN-050025R</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T19:48:27.120Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806133043363</udiDi>
    <basicUdiDi>880613300072BU</basicUdiDi>
    <tradeName>ichroma™ BNP</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Boditech Med Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000011028</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CFPC-121</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T19:48:27.108Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800208636351</udiDi>
    <basicUdiDi>88002086IFS18HG</basicUdiDi>
    <tradeName>JUST Implant System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>KJ MEDITECH Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000039683</manufacturerSrn>
    <authorisedRepresentativeName>S.B. Pharma GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005392</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LAR</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T19:48:27.093Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975965294686</udiDi>
    <basicUdiDi>697122740ABNMF</basicUdiDi>
    <tradeName>VeriEcto</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Promisemed Hangzhou Meditech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008465</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABN-1816</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T19:48:27.080Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976764672743</udiDi>
    <basicUdiDi>697676467BD004KG</basicUdiDi>
    <tradeName>06976764672743</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Anhui Xiaoshan Hope medical DEVICES Co., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000037849</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>80mm*4m</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T19:48:27.053Z</lastUpdated>
  </row>
  <row>
    <udiDi>+J021302890021</udiDi>
    <basicUdiDi>++J021S0006RC</basicUdiDi>
    <tradeName>SI-1015</tradeName>
    <deviceName></deviceName>
    <manufacturerName>W&amp;H Dentalwerk Bürmoos GmbH</manufacturerName>
    <manufacturerSrn>AT-MF-000001590</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30289002</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T19:48:27.032Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972992510963</udiDi>
    <basicUdiDi>697299251DUDBRN</basicUdiDi>
    <tradeName>Disposable Urinary Drainage  Bag</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Changzhou CareU Medical Instruments Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027623</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CU-BT-A-1000ml</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T19:48:27.019Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800208636429</udiDi>
    <basicUdiDi>88002086IFS18HG</basicUdiDi>
    <tradeName>JUST Implant System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>KJ MEDITECH Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000039683</manufacturerSrn>
    <authorisedRepresentativeName>S.B. Pharma GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005392</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AOAL</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T19:48:27.003Z</lastUpdated>
  </row>
  <row>
    <udiDi>08905080006282</udiDi>
    <basicUdiDi>8905080BUSH7E</basicUdiDi>
    <tradeName>P Flex Ureteral Stent Set Both Ends Open with String &amp; Hydrophilic Coating</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Blue Neem Medical Devices Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000021793</manufacturerSrn>
    <authorisedRepresentativeName>Arazy Group (Ireland) Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000093</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BEUSB00801431</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T19:48:26.989Z</lastUpdated>
  </row>
</eudamedExport>