<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>05051223023852</udiDi>
    <basicUdiDi>B-05051223023852</basicUdiDi>
    <tradeName>Curette, Rigid, Straight, 12mm</tradeName>
    <deviceName>Curette</deviceName>
    <manufacturerName>Purple Surgical Holdings Limited also known as Purple Surgical International Limited, Purple Surgical UK Limited and Purple Surgical Manufacturing Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000012819</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U089010</emdnCode>
    <emdnDescription>UTERINE CURETTES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PS6012</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-02T11:58:40.348Z</lastUpdated>
  </row>
  <row>
    <udiDi>05051223023845</udiDi>
    <basicUdiDi>B-05051223023845</basicUdiDi>
    <tradeName>Curette, Rigid, Straight, 11mm</tradeName>
    <deviceName>Curette</deviceName>
    <manufacturerName>Purple Surgical Holdings Limited also known as Purple Surgical International Limited, Purple Surgical UK Limited and Purple Surgical Manufacturing Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000012819</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U089010</emdnCode>
    <emdnDescription>UTERINE CURETTES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PS6011</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-02T11:58:39.547Z</lastUpdated>
  </row>
  <row>
    <udiDi>05051223023838</udiDi>
    <basicUdiDi>B-05051223023838</basicUdiDi>
    <tradeName>Curette, Rigid, Straight, 10mm</tradeName>
    <deviceName>Curette</deviceName>
    <manufacturerName>Purple Surgical Holdings Limited also known as Purple Surgical International Limited, Purple Surgical UK Limited and Purple Surgical Manufacturing Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000012819</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U089010</emdnCode>
    <emdnDescription>UTERINE CURETTES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PS6010</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-02T11:58:35.546Z</lastUpdated>
  </row>
  <row>
    <udiDi>05051223023821</udiDi>
    <basicUdiDi>B-05051223023821</basicUdiDi>
    <tradeName>Curette, Rigid, Straight, 9mm</tradeName>
    <deviceName>Curette</deviceName>
    <manufacturerName>Purple Surgical Holdings Limited also known as Purple Surgical International Limited, Purple Surgical UK Limited and Purple Surgical Manufacturing Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000012819</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U089010</emdnCode>
    <emdnDescription>UTERINE CURETTES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PS6009</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-02T11:58:34.751Z</lastUpdated>
  </row>
  <row>
    <udiDi>05051223023814</udiDi>
    <basicUdiDi>B-05051223023814</basicUdiDi>
    <tradeName>Curette, Rigid, Straight, 8mm</tradeName>
    <deviceName>Curette</deviceName>
    <manufacturerName>Purple Surgical Holdings Limited also known as Purple Surgical International Limited, Purple Surgical UK Limited and Purple Surgical Manufacturing Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000012819</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U089010</emdnCode>
    <emdnDescription>UTERINE CURETTES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PS6008</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-02T11:58:33.943Z</lastUpdated>
  </row>
  <row>
    <udiDi>05051223023807</udiDi>
    <basicUdiDi>B-05051223023807</basicUdiDi>
    <tradeName>Curette, Rigid, Straight, 7mm</tradeName>
    <deviceName>Curette</deviceName>
    <manufacturerName>Purple Surgical Holdings Limited also known as Purple Surgical International Limited, Purple Surgical UK Limited and Purple Surgical Manufacturing Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000012819</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U089010</emdnCode>
    <emdnDescription>UTERINE CURETTES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PS6007</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-02T11:58:33.153Z</lastUpdated>
  </row>
  <row>
    <udiDi>05051223003748</udiDi>
    <basicUdiDi>B-05051223003748</basicUdiDi>
    <tradeName>Spackman Uterine Manipulator/Injector</tradeName>
    <deviceName>Spackman Uterine Manipulator/Injector</deviceName>
    <manufacturerName>Purple Surgical Holdings Limited also known as Purple Surgical International Limited, Purple Surgical UK Limited and Purple Surgical Manufacturing Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000012819</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U080199</emdnCode>
    <emdnDescription>GYNAECOLOGICAL CATHETERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PS3112</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-02T11:51:30.399Z</lastUpdated>
  </row>
  <row>
    <udiDi>04974234814442</udiDi>
    <basicUdiDi>B-04974234814442</basicUdiDi>
    <tradeName>Sagami Original 002 L12 Extra Lubricated</tradeName>
    <deviceName>Polyurethane condom</deviceName>
    <manufacturerName>Sagami Manufacturers Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000039689</manufacturerSrn>
    <authorisedRepresentativeName>Sagami Europe SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000038926</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U110101</emdnCode>
    <emdnDescription>CONDOMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UES053</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-08-02T11:26:01.428Z</lastUpdated>
  </row>
  <row>
    <udiDi>04974234813940</udiDi>
    <basicUdiDi>B-04974234813940</basicUdiDi>
    <tradeName>Sagami Original 001-L5</tradeName>
    <deviceName>Polyurethane condom</deviceName>
    <manufacturerName>Sagami Manufacturers Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000039689</manufacturerSrn>
    <authorisedRepresentativeName>Sagami Europe SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000038926</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U110101</emdnCode>
    <emdnDescription>CONDOMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UES035</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-08-02T11:26:00.555Z</lastUpdated>
  </row>
  <row>
    <udiDi>04974234813933</udiDi>
    <basicUdiDi>B-04974234813933</basicUdiDi>
    <tradeName>Sagami Original 001-L2</tradeName>
    <deviceName>Polyurethane condom</deviceName>
    <manufacturerName>Sagami Manufacturers Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000039689</manufacturerSrn>
    <authorisedRepresentativeName>Sagami Europe SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000038926</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U110101</emdnCode>
    <emdnDescription>CONDOMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UES030</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-08-02T11:26:00.105Z</lastUpdated>
  </row>
  <row>
    <udiDi>04974234813926</udiDi>
    <basicUdiDi>B-04974234813926</basicUdiDi>
    <tradeName>Sagami Original 002 XL12</tradeName>
    <deviceName>Polyurethane condom</deviceName>
    <manufacturerName>Sagami Manufacturers Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000039689</manufacturerSrn>
    <authorisedRepresentativeName>Sagami Europe SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000038926</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U110101</emdnCode>
    <emdnDescription>CONDOMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UES045</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-08-02T11:25:55.758Z</lastUpdated>
  </row>
  <row>
    <udiDi>04974234813919</udiDi>
    <basicUdiDi>B-04974234813919</basicUdiDi>
    <tradeName>Sagami Original 002 XL3</tradeName>
    <deviceName>Polyurethane condom</deviceName>
    <manufacturerName>Sagami Manufacturers Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000039689</manufacturerSrn>
    <authorisedRepresentativeName>Sagami Europe SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000038926</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U110101</emdnCode>
    <emdnDescription>CONDOMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UES040</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-08-02T11:25:54.958Z</lastUpdated>
  </row>
  <row>
    <udiDi>04974234811328</udiDi>
    <basicUdiDi>B-04974234811328</basicUdiDi>
    <tradeName>Sagami Original 001-2</tradeName>
    <deviceName>Polyurethane Condom</deviceName>
    <manufacturerName>Sagami Manufacturers Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000039689</manufacturerSrn>
    <authorisedRepresentativeName>Sagami Europe SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000038926</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U110101</emdnCode>
    <emdnDescription>CONDOMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UES622</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-08-02T11:25:54.258Z</lastUpdated>
  </row>
  <row>
    <udiDi>04974234619023</udiDi>
    <basicUdiDi>B-04974234619023</basicUdiDi>
    <tradeName>Sagami Original 002-2</tradeName>
    <deviceName>Polyurethane Condom</deviceName>
    <manufacturerName>Sagami Manufacturers Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000039689</manufacturerSrn>
    <authorisedRepresentativeName>Sagami Europe SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000038926</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U110101</emdnCode>
    <emdnDescription>CONDOMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UES522</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-08-02T11:25:52.561Z</lastUpdated>
  </row>
  <row>
    <udiDi>04974234062010</udiDi>
    <basicUdiDi>B-04974234062010</basicUdiDi>
    <tradeName>Sagami Original 002-L2</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sagami Manufacturers Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000039689</manufacturerSrn>
    <authorisedRepresentativeName>Sagami Europe SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000038926</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U110101</emdnCode>
    <emdnDescription>CONDOMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UES492</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-08-02T11:23:51.265Z</lastUpdated>
  </row>
  <row>
    <udiDi>04711182608125</udiDi>
    <basicUdiDi>B-04711182608125</basicUdiDi>
    <tradeName>silicone 2-way Foley Cathrter</tradeName>
    <deviceName>silicone 2-way Foley Cathrter</deviceName>
    <manufacturerName>FORTUNE MEDICAL INSTRUMENT CORP.</manufacturerName>
    <manufacturerSrn>TW-MF-000009221</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U020299</emdnCode>
    <emdnDescription>URETERAL CATHETERS WITH BALLOON - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4833-0522</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-08-02T08:17:47.751Z</lastUpdated>
  </row>
  <row>
    <udiDi>04711182608118</udiDi>
    <basicUdiDi>B-04711182608118</basicUdiDi>
    <tradeName>silicone 2-way Foley Cathrter</tradeName>
    <deviceName>silicone 2-way Foley Cathrter</deviceName>
    <manufacturerName>FORTUNE MEDICAL INSTRUMENT CORP.</manufacturerName>
    <manufacturerSrn>TW-MF-000009221</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U020299</emdnCode>
    <emdnDescription>URETERAL CATHETERS WITH BALLOON - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4833-0520</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-08-02T08:17:43.038Z</lastUpdated>
  </row>
  <row>
    <udiDi>04711182608101</udiDi>
    <basicUdiDi>B-04711182608101</basicUdiDi>
    <tradeName>silicone 2-way Foley Cathrter</tradeName>
    <deviceName>silicone 2-way Foley Cathrter</deviceName>
    <manufacturerName>FORTUNE MEDICAL INSTRUMENT CORP.</manufacturerName>
    <manufacturerSrn>TW-MF-000009221</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U020299</emdnCode>
    <emdnDescription>URETERAL CATHETERS WITH BALLOON - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4833-0518</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-08-02T08:17:42.248Z</lastUpdated>
  </row>
  <row>
    <udiDi>04711182608095</udiDi>
    <basicUdiDi>B-04711182608095</basicUdiDi>
    <tradeName>silicone 2-way Foley Cathrter</tradeName>
    <deviceName>silicone 2-way Foley Cathrter</deviceName>
    <manufacturerName>FORTUNE MEDICAL INSTRUMENT CORP.</manufacturerName>
    <manufacturerSrn>TW-MF-000009221</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U020299</emdnCode>
    <emdnDescription>URETERAL CATHETERS WITH BALLOON - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4833-0516</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-08-02T08:17:41.364Z</lastUpdated>
  </row>
  <row>
    <udiDi>04711182608088</udiDi>
    <basicUdiDi>B-04711182608088</basicUdiDi>
    <tradeName>silicone 2-way Foley Cathrter</tradeName>
    <deviceName>silicone 2-way Foley Cathrter</deviceName>
    <manufacturerName>FORTUNE MEDICAL INSTRUMENT CORP.</manufacturerName>
    <manufacturerSrn>TW-MF-000009221</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U020299</emdnCode>
    <emdnDescription>URETERAL CATHETERS WITH BALLOON - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4833-0514</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-08-02T08:17:40.560Z</lastUpdated>
  </row>
</eudamedExport>