<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>03760043360031</udiDi>
    <basicUdiDi>4974234NRPBC0162</basicUdiDi>
    <tradeName>Protex Probe Cover Wet</tradeName>
    <deviceName>Natural Rubber Latex Ultrasound Probe Cover</deviceName>
    <manufacturerName>Sagami Rubber Industries Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000040149</manufacturerSrn>
    <authorisedRepresentativeName>Sagami Europe SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000038926</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T030102</emdnCode>
    <emdnDescription>COVER SHEATHS, INSTRUMENTS AND EQUIPMENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ES6542</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T21:56:28.568Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760043360000</udiDi>
    <basicUdiDi>B-03760043360000</basicUdiDi>
    <tradeName>Protex performance</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sagami Rubber Industries Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000040149</manufacturerSrn>
    <authorisedRepresentativeName>Sagami Europe SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000038926</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CONDOMS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>ES5612</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T06:20:08.213Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760043360048</udiDi>
    <basicUdiDi>4974234NRPBC0162</basicUdiDi>
    <tradeName>Protex Probe Cover Dry</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sagami Rubber Industries Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000040149</manufacturerSrn>
    <authorisedRepresentativeName>Sagami Europe SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000038926</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T030102</emdnCode>
    <emdnDescription>COVER SHEATHS, INSTRUMENTS AND EQUIPMENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ES6543</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T06:20:08.168Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760043360062</udiDi>
    <basicUdiDi>B-03760043360062</basicUdiDi>
    <tradeName>Callvin Protex Classic Naturel 180</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sagami Rubber Industries Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000040149</manufacturerSrn>
    <authorisedRepresentativeName>Sagami Europe SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000038926</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CONDOMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ES6547</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T06:20:08.150Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760043360079</udiDi>
    <basicUdiDi>B-03760043360079</basicUdiDi>
    <tradeName>Callvin White</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sagami Rubber Industries Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000040149</manufacturerSrn>
    <authorisedRepresentativeName>Sagami Europe SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000038926</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CONDOMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ES5974</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T06:20:08.132Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760043360086</udiDi>
    <basicUdiDi>B-03760043360086</basicUdiDi>
    <tradeName>Callvin Black</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sagami Rubber Industries Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000040149</manufacturerSrn>
    <authorisedRepresentativeName>Sagami Europe SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000038926</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CONDOMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ES5976</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T06:20:08.110Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760043360093</udiDi>
    <basicUdiDi>B-03760043360093</basicUdiDi>
    <tradeName>Callvin Gold</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sagami Rubber Industries Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000040149</manufacturerSrn>
    <authorisedRepresentativeName>Sagami Europe SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000038926</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CONDOMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ES5977</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T06:20:08.089Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760043360109</udiDi>
    <basicUdiDi>B-03760043360109</basicUdiDi>
    <tradeName>Callvin Silver</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sagami Rubber Industries Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000040149</manufacturerSrn>
    <authorisedRepresentativeName>Sagami Europe SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000038926</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CONDOMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ES5975</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T06:20:08.071Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760043360659</udiDi>
    <basicUdiDi>B-03760043360659</basicUdiDi>
    <tradeName>Protex Extra Large</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sagami Rubber Industries Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000040149</manufacturerSrn>
    <authorisedRepresentativeName>Sagami Europe SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000038926</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CONDOMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ES6414</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T06:20:08.052Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760043362752</udiDi>
    <basicUdiDi>B-03760043362752</basicUdiDi>
    <tradeName>Protex Classic Green</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sagami Rubber Industries Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000040149</manufacturerSrn>
    <authorisedRepresentativeName>Sagami Europe SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000038926</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CONDOMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ES5466</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T06:20:07.995Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760043363681</udiDi>
    <basicUdiDi>B-03760043363681</basicUdiDi>
    <tradeName>Protex Stymuleve</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sagami Rubber Industries Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000040149</manufacturerSrn>
    <authorisedRepresentativeName>Sagami Europe SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000038926</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CONDOMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ES6413</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T06:20:07.975Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760043365012</udiDi>
    <basicUdiDi>B-03760043365012</basicUdiDi>
    <tradeName>Protex Classic Naturel</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sagami Rubber Industries Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000040149</manufacturerSrn>
    <authorisedRepresentativeName>Sagami Europe SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000038926</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CONDOMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ES6411</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T06:20:07.952Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760043365302</udiDi>
    <basicUdiDi>B-03760043365302</basicUdiDi>
    <tradeName>Protex Classic Naturel</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sagami Rubber Industries Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000040149</manufacturerSrn>
    <authorisedRepresentativeName>Sagami Europe SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000038926</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CONDOMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ES5258</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T06:20:07.932Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760043365364</udiDi>
    <basicUdiDi>B-03760043365364</basicUdiDi>
    <tradeName>Protex Classic Green</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sagami Rubber Industries Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000040149</manufacturerSrn>
    <authorisedRepresentativeName>Sagami Europe SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000038926</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CONDOMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ES5465</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T06:20:07.914Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760043365425</udiDi>
    <basicUdiDi>B-03760043365425</basicUdiDi>
    <tradeName>Protex Stymuleve</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sagami Rubber Industries Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000040149</manufacturerSrn>
    <authorisedRepresentativeName>Sagami Europe SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000038926</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CONDOMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ES5391</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T06:20:07.899Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760043365777</udiDi>
    <basicUdiDi>B-03760043365777</basicUdiDi>
    <tradeName>Protex Extra Large</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sagami Rubber Industries Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000040149</manufacturerSrn>
    <authorisedRepresentativeName>Sagami Europe SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000038926</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CONDOMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ES5407</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T06:20:07.887Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760043365999</udiDi>
    <basicUdiDi>B-03760043365999</basicUdiDi>
    <tradeName>Protex Classic Green</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sagami Rubber Industries Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000040149</manufacturerSrn>
    <authorisedRepresentativeName>Sagami Europe SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000038926</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CONDOMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ES5468</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T06:20:07.871Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760043366095</udiDi>
    <basicUdiDi>B-03760043366095</basicUdiDi>
    <tradeName>Protex Anatomic Reel</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sagami Rubber Industries Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000040149</manufacturerSrn>
    <authorisedRepresentativeName>Sagami Europe SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000038926</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CONDOMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ES5615</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T06:20:07.852Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760043366125</udiDi>
    <basicUdiDi>B-03760043366125</basicUdiDi>
    <tradeName>Protex Anatomic Reel</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sagami Rubber Industries Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000040149</manufacturerSrn>
    <authorisedRepresentativeName>Sagami Europe SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000038926</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CONDOMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ES5616</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T06:20:07.828Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760043366941</udiDi>
    <basicUdiDi>B-03760043366941</basicUdiDi>
    <tradeName>Protex Standard Naturel</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sagami Rubber Industries Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000040149</manufacturerSrn>
    <authorisedRepresentativeName>Sagami Europe SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000038926</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CONDOMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ES5387</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T06:20:07.806Z</lastUpdated>
  </row>
</eudamedExport>