<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>05060259070051</udiDi>
    <basicUdiDi>B-05060259070051</basicUdiDi>
    <tradeName>Transwab</tradeName>
    <deviceName>Transwab</deviceName>
    <manufacturerName>Medical Wire &amp; Equipment Co Bath (Ltd)</manufacturerName>
    <manufacturerSrn>GB-MF-000006736</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A1102</emdnCode>
    <emdnDescription>SAMPLE COLLECTION SWABS WITH TRANSPORT MEDIUM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MW171</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T15:18:03.962Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060259070044</udiDi>
    <basicUdiDi>B-05060259070044</basicUdiDi>
    <tradeName>05060259070044</tradeName>
    <deviceName>Transwab</deviceName>
    <manufacturerName>Medical Wire &amp; Equipment Co Bath (Ltd)</manufacturerName>
    <manufacturerSrn>GB-MF-000006736</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A1102</emdnCode>
    <emdnDescription>SAMPLE COLLECTION SWABS WITH TRANSPORT MEDIUM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MW170SH</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T15:18:02.372Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060259070020</udiDi>
    <basicUdiDi>B-05060259070020</basicUdiDi>
    <tradeName>Transwab</tradeName>
    <deviceName>Transwab</deviceName>
    <manufacturerName>Medical Wire &amp; Equipment Co Bath (Ltd)</manufacturerName>
    <manufacturerSrn>GB-MF-000006736</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A1102</emdnCode>
    <emdnDescription>SAMPLE COLLECTION SWABS WITH TRANSPORT MEDIUM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MW169C</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T15:18:01.579Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060259070037</udiDi>
    <basicUdiDi>B-05060259070037</basicUdiDi>
    <tradeName>MEDICAL WIRE &amp; EQUIPMENT CO (BATH) LTD</tradeName>
    <deviceName>TRANSWAB</deviceName>
    <manufacturerName>Medical Wire &amp; Equipment Co Bath (Ltd)</manufacturerName>
    <manufacturerSrn>GB-MF-000006736</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A1102</emdnCode>
    <emdnDescription>SAMPLE COLLECTION SWABS WITH TRANSPORT MEDIUM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MW170</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T15:17:59.965Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060259070006</udiDi>
    <basicUdiDi>B-05060259070006</basicUdiDi>
    <tradeName>Transtube</tradeName>
    <deviceName>Transtube</deviceName>
    <manufacturerName>Medical Wire &amp; Equipment Co Bath (Ltd)</manufacturerName>
    <manufacturerSrn>GB-MF-000006736</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A1102</emdnCode>
    <emdnDescription>SAMPLE COLLECTION SWABS WITH TRANSPORT MEDIUM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MW167</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T15:17:57.572Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060259070013</udiDi>
    <basicUdiDi>B-05060259070013</basicUdiDi>
    <tradeName>Transwab</tradeName>
    <deviceName>Transwab</deviceName>
    <manufacturerName>Medical Wire &amp; Equipment Co Bath (Ltd)</manufacturerName>
    <manufacturerSrn>GB-MF-000006736</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A1102</emdnCode>
    <emdnDescription>SAMPLE COLLECTION SWABS WITH TRANSPORT MEDIUM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MW169P</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T15:17:55.228Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060222474381</udiDi>
    <basicUdiDi>B-05060222474381</basicUdiDi>
    <tradeName>OPTIFLUSH</tradeName>
    <deviceName>Sterile 0,9% Sodium Chloride Solution, 5mL</deviceName>
    <manufacturerName>İstem Medikal Tıbbi Cihaz ve Sanayi Ticaret Anonim Şirketi</manufacturerName>
    <manufacturerSrn>TR-MF-000017811</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A02010299</emdnCode>
    <emdnDescription>INFUSION AND IRRIGATION SYRINGES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1137</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-02T15:15:05.893Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060222474343</udiDi>
    <basicUdiDi>B-05060222474343</basicUdiDi>
    <tradeName>OPTIFLUSH</tradeName>
    <deviceName>Sterile 0,9% Sodium Chloride Solution, 3mL</deviceName>
    <manufacturerName>İstem Medikal Tıbbi Cihaz ve Sanayi Ticaret Anonim Şirketi</manufacturerName>
    <manufacturerSrn>TR-MF-000017811</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A02010299</emdnCode>
    <emdnDescription>INFUSION AND IRRIGATION SYRINGES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1136</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-02T15:15:05.096Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060222471441</udiDi>
    <basicUdiDi>B-05060222471441</basicUdiDi>
    <tradeName>OPTIFLUSH</tradeName>
    <deviceName>Sterile 0,9% Sodium Chloride Solution, 20mL</deviceName>
    <manufacturerName>İstem Medikal Tıbbi Cihaz ve Sanayi Ticaret Anonim Şirketi</manufacturerName>
    <manufacturerSrn>TR-MF-000017811</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A02010299</emdnCode>
    <emdnDescription>INFUSION AND IRRIGATION SYRINGES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1134</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-02T15:14:59.582Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060222471410</udiDi>
    <basicUdiDi>B-05060222471410</basicUdiDi>
    <tradeName>OPTIFLUSH</tradeName>
    <deviceName>Sterile 0,9% Sodium Chloride Solution,10 mL</deviceName>
    <manufacturerName>İstem Medikal Tıbbi Cihaz ve Sanayi Ticaret Anonim Şirketi</manufacturerName>
    <manufacturerSrn>TR-MF-000017811</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A02010299</emdnCode>
    <emdnDescription>INFUSION AND IRRIGATION SYRINGES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1133</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-02T15:14:58.683Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060166524333</udiDi>
    <basicUdiDi>B-05060166524333</basicUdiDi>
    <tradeName>05060166524333</tradeName>
    <deviceName>Oracol Pro</deviceName>
    <manufacturerName>Malvern Medical Developments Ltd also trading as PB Medical Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000014481</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A1101</emdnCode>
    <emdnDescription>SAMPLE COLLECTION NEUTRAL SWABS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S20</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-02T14:56:53.291Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060166524326</udiDi>
    <basicUdiDi>B-05060166524326</basicUdiDi>
    <tradeName>05060166524326</tradeName>
    <deviceName>Oracol +</deviceName>
    <manufacturerName>Malvern Medical Developments Ltd also trading as PB Medical Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000014481</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A1101</emdnCode>
    <emdnDescription>SAMPLE COLLECTION NEUTRAL SWABS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S14</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-02T14:56:39.508Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060166524319</udiDi>
    <basicUdiDi>B-05060166524319</basicUdiDi>
    <tradeName>05060166524319</tradeName>
    <deviceName>Oracol Swab</deviceName>
    <manufacturerName>Malvern Medical Developments Ltd also trading as PB Medical Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000014481</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A1101</emdnCode>
    <emdnDescription>SAMPLE COLLECTION NEUTRAL SWABS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S11</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-02T14:56:37.910Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060166524302</udiDi>
    <basicUdiDi>B-05060166524302</basicUdiDi>
    <tradeName>05060166524302</tradeName>
    <deviceName>Oracol Saliva Collection Device</deviceName>
    <manufacturerName>Malvern Medical Developments Ltd also trading as PB Medical Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000014481</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A1101</emdnCode>
    <emdnDescription>SAMPLE COLLECTION NEUTRAL SWABS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S10</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-02T14:56:37.100Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060152310537</udiDi>
    <basicUdiDi>B-05060152310537</basicUdiDi>
    <tradeName>Libra Cather Valve</tradeName>
    <deviceName>Libra Lever Catheter valve</deviceName>
    <manufacturerName>Clinisupplies GB Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000023993</manufacturerSrn>
    <authorisedRepresentativeName>MD REPS Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000040375</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A06030399</emdnCode>
    <emdnDescription>URINE COLLECTION SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>10540A</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T14:51:29.237Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060077032996</udiDi>
    <basicUdiDi>B-05060077032996</basicUdiDi>
    <tradeName>Bile Bags</tradeName>
    <deviceName>Sterile Bile Bags</deviceName>
    <manufacturerName>Clinisupplies (Nanjing) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000026449</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A0601010102</emdnCode>
    <emdnDescription>DRAINAGE SYSTEMS WITH RESERVOIR</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MD-T400</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T14:49:09.517Z</lastUpdated>
  </row>
  <row>
    <udiDi>05059358049792</udiDi>
    <basicUdiDi>B-05059358049792</basicUdiDi>
    <tradeName>05059358049792</tradeName>
    <deviceName>STERILE IRRIGATION TUBE KIT - D SHANK</deviceName>
    <manufacturerName>Zethon Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000014309</manufacturerSrn>
    <authorisedRepresentativeName>De Soutter Medical Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000438</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A03040299</emdnCode>
    <emdnDescription>IRRIGATION KITS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S101691</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-02T14:36:59.543Z</lastUpdated>
  </row>
  <row>
    <udiDi>05059358050378</udiDi>
    <basicUdiDi>B-05059358050378</basicUdiDi>
    <tradeName>05059358050378</tradeName>
    <deviceName>STERILE IRRIGATION TUBE KIT - C SHANK, LOW FLOW RATE</deviceName>
    <manufacturerName>Zethon Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000014309</manufacturerSrn>
    <authorisedRepresentativeName>De Soutter Medical Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000438</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A03040299</emdnCode>
    <emdnDescription>IRRIGATION KITS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S101688</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-02T14:36:57.049Z</lastUpdated>
  </row>
  <row>
    <udiDi>05059358034989</udiDi>
    <basicUdiDi>B-05059358034989</basicUdiDi>
    <tradeName>05059358034989</tradeName>
    <deviceName>STERILE IRRIGATION TUBE KIT - C SHANK, HIGH FLOW RATE</deviceName>
    <manufacturerName>Zethon Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000014309</manufacturerSrn>
    <authorisedRepresentativeName>De Soutter Medical Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000438</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A03040299</emdnCode>
    <emdnDescription>IRRIGATION KITS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S101461</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-02T14:30:03.392Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056115403507</udiDi>
    <basicUdiDi>B-05056115403507</basicUdiDi>
    <tradeName>Reusable Oral syringe</tradeName>
    <deviceName>10ml Reusable Oral Tip Syringe</deviceName>
    <manufacturerName>Medicina Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000041402</manufacturerSrn>
    <authorisedRepresentativeName>HMC PREMEDICAL S.P.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000029439</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A020299</emdnCode>
    <emdnDescription>REUSABLE SYRINGES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OTH10</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-02T14:30:00.991Z</lastUpdated>
  </row>
</eudamedExport>