<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-LTG30ST3X</udiDi>
    <basicUdiDi>B-LTG30ST3X</basicUdiDi>
    <tradeName>UNISPEC</tradeName>
    <deviceName>Vaginal speculum single use</deviceName>
    <manufacturerName>S.A.M. s.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000035723</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U089006</emdnCode>
    <emdnDescription>VAGINAL SPECULUM, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LRG30ST</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:53:21.001Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-LRG30SC23</udiDi>
    <basicUdiDi>B-LRG30SC23</basicUdiDi>
    <tradeName>UNISPEC</tradeName>
    <deviceName>VAGINAL SPECULUM SINGLE USE</deviceName>
    <manufacturerName>S.A.M. s.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000035723</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U089006</emdnCode>
    <emdnDescription>VAGINAL SPECULUM, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LRG30SC</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:53:13.796Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-HK-A067A</udiDi>
    <basicUdiDi>B-HK-A067A</basicUdiDi>
    <tradeName>Vaginal Speculum</tradeName>
    <deviceName>Disposable Vaginal Speculums</deviceName>
    <manufacturerName>Changzhou Huankang Medical Device Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009030</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U089006</emdnCode>
    <emdnDescription>VAGINAL SPECULUM, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HK-A06</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:54:47.190Z</lastUpdated>
  </row>
  <row>
    <udiDi>47889</udiDi>
    <basicUdiDi>B-47889</basicUdiDi>
    <tradeName>47889</tradeName>
    <deviceName>PESSAIRE CUBIC T10 - 74 MM</deviceName>
    <manufacturerName>Medgyn International, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000031450</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U089005</emdnCode>
    <emdnDescription>PESSARIANS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>47889</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T17:01:15.199Z</lastUpdated>
  </row>
  <row>
    <udiDi>47888</udiDi>
    <basicUdiDi>B-47888</basicUdiDi>
    <tradeName>47888</tradeName>
    <deviceName>PESSAIRE CUBIC T9 - 69 MM</deviceName>
    <manufacturerName>Medgyn International, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000031450</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U089005</emdnCode>
    <emdnDescription>PESSARIANS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>47888</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T17:01:14.401Z</lastUpdated>
  </row>
  <row>
    <udiDi>47887</udiDi>
    <basicUdiDi>B-47887</basicUdiDi>
    <tradeName>47887</tradeName>
    <deviceName>PESSAIRE CUBIC T8 - 63 MM</deviceName>
    <manufacturerName>Medgyn International, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000031450</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U089005</emdnCode>
    <emdnDescription>PESSARIANS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>47887</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T17:01:13.612Z</lastUpdated>
  </row>
  <row>
    <udiDi>47886</udiDi>
    <basicUdiDi>B-47886</basicUdiDi>
    <tradeName>47886</tradeName>
    <deviceName>PESSAIRE CUBIC T7 - 55 MM</deviceName>
    <manufacturerName>Medgyn International, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000031450</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U089005</emdnCode>
    <emdnDescription>PESSARIANS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>47886</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T17:01:12.800Z</lastUpdated>
  </row>
  <row>
    <udiDi>47885</udiDi>
    <basicUdiDi>B-47885</basicUdiDi>
    <tradeName>47885</tradeName>
    <deviceName>PESSAIRE CUBIC T6 - 49 MM</deviceName>
    <manufacturerName>Medgyn International, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000031450</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U089005</emdnCode>
    <emdnDescription>PESSARIANS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>47885</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T17:01:08.798Z</lastUpdated>
  </row>
  <row>
    <udiDi>47884</udiDi>
    <basicUdiDi>B-47884</basicUdiDi>
    <tradeName>47884</tradeName>
    <deviceName>PESSAIRE CUBIC T5 - 45 MM</deviceName>
    <manufacturerName>Medgyn International, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000031450</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U089005</emdnCode>
    <emdnDescription>PESSARIANS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>47884</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T17:01:08.000Z</lastUpdated>
  </row>
  <row>
    <udiDi>47883</udiDi>
    <basicUdiDi>B-47883</basicUdiDi>
    <tradeName>47883</tradeName>
    <deviceName>PESSAIRE CUBIC T4 - 40 MM</deviceName>
    <manufacturerName>Medgyn International, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000031450</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U089005</emdnCode>
    <emdnDescription>PESSARIANS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>47883</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T17:01:07.195Z</lastUpdated>
  </row>
  <row>
    <udiDi>47882</udiDi>
    <basicUdiDi>B-47882</basicUdiDi>
    <tradeName>47882</tradeName>
    <deviceName>PESSAIRE CUBIC T3 - 36 MM</deviceName>
    <manufacturerName>Medgyn International, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000031450</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U089005</emdnCode>
    <emdnDescription>PESSARIANS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>47882</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T17:01:06.396Z</lastUpdated>
  </row>
  <row>
    <udiDi>47881</udiDi>
    <basicUdiDi>B-47881</basicUdiDi>
    <tradeName>47881</tradeName>
    <deviceName>PESSAIRE CUBIC T2 - 32 MM</deviceName>
    <manufacturerName>Medgyn International, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000031450</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U089005</emdnCode>
    <emdnDescription>PESSARIANS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>47881</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T17:01:02.402Z</lastUpdated>
  </row>
  <row>
    <udiDi>47880</udiDi>
    <basicUdiDi>B-47880</basicUdiDi>
    <tradeName>47880</tradeName>
    <deviceName>PESSAIRE CUBIC T1 - 29 MM</deviceName>
    <manufacturerName>Medgyn International, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000031450</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U089005</emdnCode>
    <emdnDescription>PESSARIANS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>47880</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T17:01:01.596Z</lastUpdated>
  </row>
  <row>
    <udiDi>47879</udiDi>
    <basicUdiDi>B-47879</basicUdiDi>
    <tradeName>47879</tradeName>
    <deviceName>PESSAIRE CUBIC TO - 25 MM</deviceName>
    <manufacturerName>Medgyn International, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000031450</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U089005</emdnCode>
    <emdnDescription>PESSARIANS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>47879</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T17:01:00.808Z</lastUpdated>
  </row>
  <row>
    <udiDi>47878</udiDi>
    <basicUdiDi>B-47878</basicUdiDi>
    <tradeName>47878</tradeName>
    <deviceName>PESSAIRE GYN&amp;RING T9 - 102 MM</deviceName>
    <manufacturerName>Medgyn International, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000031450</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U089005</emdnCode>
    <emdnDescription>PESSARIANS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>47878</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T17:00:59.989Z</lastUpdated>
  </row>
  <row>
    <udiDi>47877</udiDi>
    <basicUdiDi>B-47877</basicUdiDi>
    <tradeName>47877</tradeName>
    <deviceName>PESSAIRE GYN&amp;RING T8 - 96 MM</deviceName>
    <manufacturerName>Medgyn International, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000031450</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U089005</emdnCode>
    <emdnDescription>PESSARIANS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>47877</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T17:00:56.005Z</lastUpdated>
  </row>
  <row>
    <udiDi>47876</udiDi>
    <basicUdiDi>B-47876</basicUdiDi>
    <tradeName>47876</tradeName>
    <deviceName>PESSAIRE GYN&amp;RING T7 - 89 MM</deviceName>
    <manufacturerName>Medgyn International, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000031450</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U089005</emdnCode>
    <emdnDescription>PESSARIANS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>47876</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T17:00:55.199Z</lastUpdated>
  </row>
  <row>
    <udiDi>47875</udiDi>
    <basicUdiDi>B-47875</basicUdiDi>
    <tradeName>47875</tradeName>
    <deviceName>PESSAIRE GYN&amp;RING T6 - 82 MM</deviceName>
    <manufacturerName>Medgyn International, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000031450</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U089005</emdnCode>
    <emdnDescription>PESSARIANS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>47875</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T17:00:54.387Z</lastUpdated>
  </row>
  <row>
    <udiDi>47874</udiDi>
    <basicUdiDi>B-47874</basicUdiDi>
    <tradeName>47874</tradeName>
    <deviceName>PESSAIRE GYN&amp;RING T5 - 74 MM</deviceName>
    <manufacturerName>Medgyn International, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000031450</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U089005</emdnCode>
    <emdnDescription>PESSARIANS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>47874</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T17:00:53.582Z</lastUpdated>
  </row>
  <row>
    <udiDi>47871</udiDi>
    <basicUdiDi>B-47871</basicUdiDi>
    <tradeName>47871</tradeName>
    <deviceName>47871</deviceName>
    <manufacturerName>Medgyn International, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000031450</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U089005</emdnCode>
    <emdnDescription>PESSARIANS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>47871</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T17:00:49.589Z</lastUpdated>
  </row>
</eudamedExport>