<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06262115502792</udiDi>
    <basicUdiDi>B-06262115502792</basicUdiDi>
    <tradeName>AVA Hypodermic Needle</tradeName>
    <deviceName>Hypodermic Needle 18G × 38 mm, Regular Wall, Pink</deviceName>
    <manufacturerName>AVAPEZESHK</manufacturerName>
    <manufacturerSrn>IR-MF-000048464</manufacturerSrn>
    <authorisedRepresentativeName>ORYX DIS TICARET LIMITED SIRKETI</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>TR-AR-000046684</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A0101010102</emdnCode>
    <emdnDescription>HYPODERMIC SYRINGE NEEDLES, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N18382</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-03T00:44:19.214Z</lastUpdated>
  </row>
  <row>
    <udiDi>06262115502785</udiDi>
    <basicUdiDi>B-06262115502785</basicUdiDi>
    <tradeName>AVA Hypodermic Needle</tradeName>
    <deviceName>Hypodermic Needle 18G × 38 mm, Thin Wall, Pink</deviceName>
    <manufacturerName>AVAPEZESHK</manufacturerName>
    <manufacturerSrn>IR-MF-000048464</manufacturerSrn>
    <authorisedRepresentativeName>ORYX DIS TICARET LIMITED SIRKETI</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>TR-AR-000046684</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A0101010102</emdnCode>
    <emdnDescription>HYPODERMIC SYRINGE NEEDLES, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N18381</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-03T00:44:15.058Z</lastUpdated>
  </row>
  <row>
    <udiDi>06262115502778</udiDi>
    <basicUdiDi>B-06262115502778</basicUdiDi>
    <tradeName>AVA Hypodermic Needle</tradeName>
    <deviceName>Hypodermic Needle 19G × 25 mm, Thin Wall, Cream</deviceName>
    <manufacturerName>AVAPEZESHK</manufacturerName>
    <manufacturerSrn>IR-MF-000048464</manufacturerSrn>
    <authorisedRepresentativeName>ORYX DIS TICARET LIMITED SIRKETI</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>TR-AR-000046684</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A0101010102</emdnCode>
    <emdnDescription>HYPODERMIC SYRINGE NEEDLES, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N19251</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-03T00:44:14.344Z</lastUpdated>
  </row>
  <row>
    <udiDi>06262115502761</udiDi>
    <basicUdiDi>B-06262115502761</basicUdiDi>
    <tradeName>AVA Hypodermic Needle</tradeName>
    <deviceName>Hypodermic Needle 19G × 32 mm, Thin Wall, Cream</deviceName>
    <manufacturerName>AVAPEZESHK</manufacturerName>
    <manufacturerSrn>IR-MF-000048464</manufacturerSrn>
    <authorisedRepresentativeName>ORYX DIS TICARET LIMITED SIRKETI</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>TR-AR-000046684</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A0101010102</emdnCode>
    <emdnDescription>HYPODERMIC SYRINGE NEEDLES, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N19321</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-03T00:44:13.480Z</lastUpdated>
  </row>
  <row>
    <udiDi>06223019820009</udiDi>
    <basicUdiDi>B-06223019820009</basicUdiDi>
    <tradeName>ULTRAMED EXTENSION TUBE Low Pressure Without 3 Way Stop Cock (2 Way)- 20 cm</tradeName>
    <deviceName>ULTRAMED EXTENSION TUBE</deviceName>
    <manufacturerName>Ultra For Medical Products (Ultramed) U.M.I.C (S.A.E)</manufacturerName>
    <manufacturerSrn>EG-MF-000038562</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A03020101</emdnCode>
    <emdnDescription>LOW PRESSURE EXTENSION LINES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1011/LP-20/2</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-08-03T00:40:47.276Z</lastUpdated>
  </row>
  <row>
    <udiDi>06223004251641</udiDi>
    <basicUdiDi>B-06223004251641</basicUdiDi>
    <tradeName>ULTRAMED FLOW REGULATOR</tradeName>
    <deviceName>ULTRAMED FLOW REGULATOR</deviceName>
    <manufacturerName>Ultra For Medical Products (Ultramed) U.M.I.C (S.A.E)</manufacturerName>
    <manufacturerSrn>EG-MF-000038562</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A030104</emdnCode>
    <emdnDescription>FLOW REGULATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1010</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-08-03T00:29:44.627Z</lastUpdated>
  </row>
  <row>
    <udiDi>06223004250880</udiDi>
    <basicUdiDi>B-06223004250880</basicUdiDi>
    <tradeName>Ultramed Burette Set measured volume fluid administration set- 100 ml</tradeName>
    <deviceName>Ultramed Burette Set measured volume fluid administration set- 100 ml</deviceName>
    <manufacturerName>Ultra For Medical Products (Ultramed) U.M.I.C (S.A.E)</manufacturerName>
    <manufacturerSrn>EG-MF-000038562</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A03010104</emdnCode>
    <emdnDescription>INFUSION MICRO-CONTROLLERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1016-100</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-08-03T00:29:39.880Z</lastUpdated>
  </row>
  <row>
    <udiDi>06130010000319</udiDi>
    <basicUdiDi>B-06130010000319</basicUdiDi>
    <tradeName>ULTRALISS® SERINGUE 5 ml</tradeName>
    <deviceName>SYRINGE 5ml</deviceName>
    <manufacturerName>Industries Médico-chirurgicales</manufacturerName>
    <manufacturerSrn>DZ-MF-000041521</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A02010499</emdnCode>
    <emdnDescription>SYRINGES FOR INJECTOR, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>DM 0199105</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-03T00:29:24.617Z</lastUpdated>
  </row>
  <row>
    <udiDi>06130010000302</udiDi>
    <basicUdiDi>B-06130010000302</basicUdiDi>
    <tradeName>TRANSFUSEUR</tradeName>
    <deviceName>TRANSFUSION SET</deviceName>
    <manufacturerName>Industries Médico-chirurgicales</manufacturerName>
    <manufacturerSrn>DZ-MF-000041521</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A03040199</emdnCode>
    <emdnDescription>INFUSION KITS (WITH OR W/O PUMP), SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>DM0399101</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-03T00:29:23.802Z</lastUpdated>
  </row>
  <row>
    <udiDi>06130010000296</udiDi>
    <basicUdiDi>B-06130010000296</basicUdiDi>
    <tradeName>PERFUSEUR</tradeName>
    <deviceName>infusion set</deviceName>
    <manufacturerName>Industries Médico-chirurgicales</manufacturerName>
    <manufacturerSrn>DZ-MF-000041521</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A03040199</emdnCode>
    <emdnDescription>INFUSION KITS (WITH OR W/O PUMP), SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>DM0299101</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-03T00:29:23.006Z</lastUpdated>
  </row>
  <row>
    <udiDi>06935491700037</udiDi>
    <basicUdiDi>693549171500KA</basicUdiDi>
    <tradeName>06935491700037</tradeName>
    <deviceName>Disposable Syringes without Needle</deviceName>
    <manufacturerName>Jiangsu Kanghua Medical Equipment Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033842</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A020102020102</emdnCode>
    <emdnDescription>INFUSION AND IRRIGATION SYRINGES, LUER LOCK CONE, 3-PIECE WITHOUT NEEDLE, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PSM4100-02</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T23:59:37.653Z</lastUpdated>
  </row>
  <row>
    <udiDi>06935491700044</udiDi>
    <basicUdiDi>693549171500KA</basicUdiDi>
    <tradeName>06935491700044</tradeName>
    <deviceName>Disposable Syringes without Needle</deviceName>
    <manufacturerName>Jiangsu Kanghua Medical Equipment Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033842</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A020102020102</emdnCode>
    <emdnDescription>INFUSION AND IRRIGATION SYRINGES, LUER LOCK CONE, 3-PIECE WITHOUT NEEDLE, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PSM4100-05</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T23:59:37.602Z</lastUpdated>
  </row>
  <row>
    <udiDi>06935491700136</udiDi>
    <basicUdiDi>693549171100JN</basicUdiDi>
    <tradeName>06935491700136</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jiangsu Kanghua Medical Equipment Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033842</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A020102010202</emdnCode>
    <emdnDescription>INFUSION AND IRRIGATION SYRINGES, LUER CONE, 3-PIECE WITHOUT NEEDLE, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PSM4103BFs</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T23:59:16.430Z</lastUpdated>
  </row>
  <row>
    <udiDi>06935491710609</udiDi>
    <basicUdiDi>693549171200JT</basicUdiDi>
    <tradeName>06935491710609</tradeName>
    <deviceName>Disposable Catheter Tip Syringes</deviceName>
    <manufacturerName>Jiangsu Kanghua Medical Equipment Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033842</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A02010203</emdnCode>
    <emdnDescription>INFUSION AND IRRIGATION SYRINGES, CATHETER CONE, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CXQ-18</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-02T23:58:54.861Z</lastUpdated>
  </row>
  <row>
    <udiDi>06935491725757</udiDi>
    <basicUdiDi>693549171600KF</basicUdiDi>
    <tradeName>06935491725757</tradeName>
    <deviceName>Disposable Insulin Syringes without Needle</deviceName>
    <manufacturerName>Jiangsu Kanghua Medical Equipment Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033842</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A02010602</emdnCode>
    <emdnDescription>INSULIN SYRINGES W/O FIXED NEEDLES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>YDS-383</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T23:58:54.290Z</lastUpdated>
  </row>
  <row>
    <udiDi>05999039512095</udiDi>
    <basicUdiDi>B-05999039512095</basicUdiDi>
    <tradeName>Securegard</tradeName>
    <deviceName>Securegard 1 ml 25Gx1" syringe</deviceName>
    <manufacturerName>SafeGard Medical /Hungary/ Gyógyászati Eszközgyártó és Forgalmazó Korlátolt Felelősségű Társaság</manufacturerName>
    <manufacturerSrn>HU-MF-000020840</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A0101010101</emdnCode>
    <emdnDescription>HYPODERMIC SYRINGE NEEDLES, WITH SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5318R</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-08-02T22:46:01.173Z</lastUpdated>
  </row>
  <row>
    <udiDi>05999039508425</udiDi>
    <basicUdiDi>B-05999039508425</basicUdiDi>
    <tradeName>Securegard</tradeName>
    <deviceName>Securegard 3 ml 23Gx1" syringe</deviceName>
    <manufacturerName>SafeGard Medical /Hungary/ Gyógyászati Eszközgyártó és Forgalmazó Korlátolt Felelősségű Társaság</manufacturerName>
    <manufacturerSrn>HU-MF-000020840</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A0101010101</emdnCode>
    <emdnDescription>HYPODERMIC SYRINGE NEEDLES, WITH SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5348E</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-08-02T22:46:00.345Z</lastUpdated>
  </row>
  <row>
    <udiDi>05944759078000</udiDi>
    <basicUdiDi>B-05944759078000</basicUdiDi>
    <tradeName>Irigator Ultra Practic 350 ml</tradeName>
    <deviceName>Irigator Ultra Practic 350 ml</deviceName>
    <manufacturerName>S.C. MEV-PLASTIC S.R.L.</manufacturerName>
    <manufacturerSrn>RO-MF-000022689</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A03040299</emdnCode>
    <emdnDescription>IRRIGATION KITS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Mv001</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-08-02T22:44:57.063Z</lastUpdated>
  </row>
  <row>
    <udiDi>06941165003342</udiDi>
    <basicUdiDi>69411650000000187A</basicUdiDi>
    <tradeName>Disposable Biopsy Guides</tradeName>
    <deviceName>Disposable Biopsy Guides</deviceName>
    <manufacturerName>Suzhou Leapmed Healthcare Corporation</manufacturerName>
    <manufacturerSrn>CN-MF-000013964</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A018002</emdnCode>
    <emdnDescription>NEEDLE GUIDES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10207502</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-02T22:39:44.399Z</lastUpdated>
  </row>
  <row>
    <udiDi>06941165004189</udiDi>
    <basicUdiDi>69411650000000187A</basicUdiDi>
    <tradeName>Disposable Biopsy Guides</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Suzhou Leapmed Healthcare Corporation</manufacturerName>
    <manufacturerSrn>CN-MF-000013964</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A018002</emdnCode>
    <emdnDescription>NEEDLE GUIDES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10208702</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T22:39:44.304Z</lastUpdated>
  </row>
</eudamedExport>