<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08052440109494</udiDi>
    <basicUdiDi>B-08052440109494</basicUdiDi>
    <tradeName>Intro</tradeName>
    <deviceName>Intro</deviceName>
    <manufacturerName>M.D.L. S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000011599</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A018003</emdnCode>
    <emdnDescription>NEEDLE INTRODUCERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PT17046</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-07T16:31:21.141Z</lastUpdated>
  </row>
  <row>
    <udiDi>08052440108114</udiDi>
    <basicUdiDi>B-08052440108114</basicUdiDi>
    <tradeName>Intro</tradeName>
    <deviceName>Intro</deviceName>
    <manufacturerName>M.D.L. S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000011599</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A018003</emdnCode>
    <emdnDescription>NEEDLE INTRODUCERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PT17040</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-07T16:30:51.594Z</lastUpdated>
  </row>
  <row>
    <udiDi>08052440106394</udiDi>
    <basicUdiDi>B-08052440106394</basicUdiDi>
    <tradeName>Intro</tradeName>
    <deviceName>Intro</deviceName>
    <manufacturerName>M.D.L. S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000011599</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A018003</emdnCode>
    <emdnDescription>NEEDLE INTRODUCERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PT17140</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-07T16:28:33.482Z</lastUpdated>
  </row>
  <row>
    <udiDi>08052440106356</udiDi>
    <basicUdiDi>B-08052440106356</basicUdiDi>
    <tradeName>Intro</tradeName>
    <deviceName>Intro</deviceName>
    <manufacturerName>M.D.L. S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000011599</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A018003</emdnCode>
    <emdnDescription>NEEDLE INTRODUCERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PT15140</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-07T16:28:31.889Z</lastUpdated>
  </row>
  <row>
    <udiDi>08052440106325</udiDi>
    <basicUdiDi>B-08052440106325</basicUdiDi>
    <tradeName>Intro</tradeName>
    <deviceName>Intro</deviceName>
    <manufacturerName>M.D.L. S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000011599</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A018003</emdnCode>
    <emdnDescription>NEEDLE INTRODUCERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PT15075</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-07T16:28:29.485Z</lastUpdated>
  </row>
  <row>
    <udiDi>08052440106295</udiDi>
    <basicUdiDi>B-08052440106295</basicUdiDi>
    <tradeName>Intro</tradeName>
    <deviceName>Intro</deviceName>
    <manufacturerName>M.D.L. S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000011599</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A018003</emdnCode>
    <emdnDescription>NEEDLE INTRODUCERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PT13110</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-07T16:28:27.904Z</lastUpdated>
  </row>
  <row>
    <udiDi>08052440106288</udiDi>
    <basicUdiDi>B-08052440106288</basicUdiDi>
    <tradeName>Intro</tradeName>
    <deviceName>Intro</deviceName>
    <manufacturerName>M.D.L. S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000011599</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A018003</emdnCode>
    <emdnDescription>NEEDLE INTRODUCERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PT13095</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-07T16:28:27.095Z</lastUpdated>
  </row>
  <row>
    <udiDi>10801902199307</udiDi>
    <basicUdiDi>08019020000000000000236KP</basicUdiDi>
    <tradeName>Insertion Set for use with Arrow(R) 5.5 Fr. PICC</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Arrow International LLC (Subsidiary of Teleflex Incorporated)</manufacturerName>
    <manufacturerSrn>US-PR-000023158</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A018003</emdnCode>
    <emdnDescription>NEEDLE INTRODUCERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EU-00755-45</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:38:52.060Z</lastUpdated>
  </row>
  <row>
    <udiDi>10801902199345</udiDi>
    <basicUdiDi>08019020000000000000236KP</basicUdiDi>
    <tradeName>Insertion Set for use with 6 Fr. PICC</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Arrow International LLC (Subsidiary of Teleflex Incorporated)</manufacturerName>
    <manufacturerSrn>US-PR-000023158</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A018003</emdnCode>
    <emdnDescription>NEEDLE INTRODUCERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EU-00760-45</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:38:52.036Z</lastUpdated>
  </row>
  <row>
    <udiDi>10801902199505</udiDi>
    <basicUdiDi>08019020000000000000236KP</basicUdiDi>
    <tradeName>Insertion Set for use with Arrow(R) 4 Fr. PICC</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Arrow International LLC (Subsidiary of Teleflex Incorporated)</manufacturerName>
    <manufacturerSrn>US-PR-000023158</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A018003</emdnCode>
    <emdnDescription>NEEDLE INTRODUCERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EU-00740-45</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:38:51.775Z</lastUpdated>
  </row>
  <row>
    <udiDi>10801902199512</udiDi>
    <basicUdiDi>08019020000000000000236KP</basicUdiDi>
    <tradeName>Insertion Set for use with Arrow(R) 4.5 Fr. PICC</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Arrow International LLC (Subsidiary of Teleflex Incorporated)</manufacturerName>
    <manufacturerSrn>US-PR-000023158</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A018003</emdnCode>
    <emdnDescription>NEEDLE INTRODUCERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EU-00745-45</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:38:51.747Z</lastUpdated>
  </row>
  <row>
    <udiDi>00020221277517</udiDi>
    <basicUdiDi>B-00020221277517</basicUdiDi>
    <tradeName>EXEL SAFETY IV CATH 24GX3/4"</tradeName>
    <deviceName>IV Catheter</deviceName>
    <manufacturerName>Exelint International, Co.</manufacturerName>
    <manufacturerSrn>US-MF-000037396</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A018003</emdnCode>
    <emdnDescription>NEEDLE INTRODUCERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>27751</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T06:04:15.693Z</lastUpdated>
  </row>
  <row>
    <udiDi>00020221277265</udiDi>
    <basicUdiDi>B-00020221277265</basicUdiDi>
    <tradeName>EXEL SAFETY IV CATH 14GX1-1/4"</tradeName>
    <deviceName>IV Catheter</deviceName>
    <manufacturerName>Exelint International, Co.</manufacturerName>
    <manufacturerSrn>US-MF-000037396</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A018003</emdnCode>
    <emdnDescription>NEEDLE INTRODUCERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>27726</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T06:04:14.101Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902141110421</udiDi>
    <basicUdiDi>89021414031Q2</basicUdiDi>
    <tradeName>SURU</tradeName>
    <deviceName>INTRODUCER NEEDLE / SELDINGER INTRODUCER NEEDLE</deviceName>
    <manufacturerName>SURU INTERNATIONAL PVT LTD</manufacturerName>
    <manufacturerSrn>IN-MF-000023736</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A018003</emdnCode>
    <emdnDescription>NEEDLE INTRODUCERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4031.18.70</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:26:12.580Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809220580796</udiDi>
    <basicUdiDi>8809920580796DH</basicUdiDi>
    <tradeName>DANA Inserter-R</tradeName>
    <deviceName>DANA Inserter R</deviceName>
    <manufacturerName>SOOIL Development Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000008627</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A018003</emdnCode>
    <emdnDescription>NEEDLE INTRODUCERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SD351</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:03:00.419Z</lastUpdated>
  </row>
  <row>
    <udiDi>08052286590272</udiDi>
    <basicUdiDi>805228659EIAG20020xxxLB</basicUdiDi>
    <tradeName>INTRODUCER</tradeName>
    <deviceName>INTRODUCER</deviceName>
    <manufacturerName>ELESTA SpA</manufacturerName>
    <manufacturerSrn>IT-MF-000037909</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A018003</emdnCode>
    <emdnDescription>NEEDLE INTRODUCERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EI AG2 0020 620</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T06:21:17.859Z</lastUpdated>
  </row>
  <row>
    <udiDi>07332699000393</udiDi>
    <basicUdiDi>7332699_330_012_WU</basicUdiDi>
    <tradeName>07332699000393</tradeName>
    <deviceName>Splitable Introducer SI-2</deviceName>
    <manufacturerName>M Dialysis AB</manufacturerName>
    <manufacturerSrn>SE-MF-000017466</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A018003</emdnCode>
    <emdnDescription>NEEDLE INTRODUCERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8010343</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T01:09:03.661Z</lastUpdated>
  </row>
  <row>
    <udiDi>04580708058894</udiDi>
    <basicUdiDi>4571225300006UG</basicUdiDi>
    <tradeName>TSK Co-axial Guide Needle</tradeName>
    <deviceName>TSK Co-axial Guide Needle</deviceName>
    <manufacturerName>TSK Laboratory, Japan</manufacturerName>
    <manufacturerSrn>JP-MF-000008485</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A018003</emdnCode>
    <emdnDescription>NEEDLE INTRODUCERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CGNACE-140753</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T20:56:37.336Z</lastUpdated>
  </row>
  <row>
    <udiDi>15420045504837</udiDi>
    <basicUdiDi>54200455ATECEVIVAHANDPCHA</basicUdiDi>
    <tradeName>ATEC Breast Biopsy and Excision System Handpiece</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hologic, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000045852</manufacturerSrn>
    <authorisedRepresentativeName>Hologic BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000127</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A018003</emdnCode>
    <emdnDescription>NEEDLE INTRODUCERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ATEC 0909-12</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T10:22:24.320Z</lastUpdated>
  </row>
  <row>
    <udiDi>15420045504844</udiDi>
    <basicUdiDi>54200455ATECEVIVAHANDPCHA</basicUdiDi>
    <tradeName>ATEC Breast Biopsy and Excision System Handpiece</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hologic, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000045852</manufacturerSrn>
    <authorisedRepresentativeName>Hologic BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000127</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A018003</emdnCode>
    <emdnDescription>NEEDLE INTRODUCERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ATEC 0909-20</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T10:22:24.297Z</lastUpdated>
  </row>
</eudamedExport>