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<eudamedExport entity="devices">
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    <udiDi>04262410680005</udiDi>
    <basicUdiDi>426241068KIRKIM94</basicUdiDi>
    <tradeName>04262410680005</tradeName>
    <deviceName>Coaxial Interventional Needle</deviceName>
    <manufacturerName>ITP Innovative Tomography Products GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000008634</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A01020102</emdnCode>
    <emdnDescription>ASPIRATION FINE NEEDLES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KIM25/03N</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T02:31:46.960Z</lastUpdated>
  </row>
  <row>
    <udiDi>08904148105486</udiDi>
    <basicUdiDi>B-08904148105486</basicUdiDi>
    <tradeName>ACE Ultra HD EBUS FNA Needle, 25 G, 2.0 mm, 0-5 cm, 4.1 Fr, Compatible with Pentax Bronchoscope</tradeName>
    <deviceName>Ultra HD EBUS FNA Needle, 25 G, 2.0 mm, 0-5 cm, 4.1 Fr, Compatible with Pentax Brand Bronchoscope</deviceName>
    <manufacturerName>ACE MEDICAL DEVICES PVT LTD</manufacturerName>
    <manufacturerSrn>IN-MF-000023786</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A01020102</emdnCode>
    <emdnDescription>ASPIRATION FINE NEEDLES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AEBUS-FNA-25-P</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-25T04:08:21.054Z</lastUpdated>
  </row>
  <row>
    <udiDi>08904148105479</udiDi>
    <basicUdiDi>B-08904148105479</basicUdiDi>
    <tradeName>ACE Ultra HD EBUS FNA Needle, 19 G, 2.0 mm, 0-5 cm, 4.1 Fr, Compatible with Pentax Brand</tradeName>
    <deviceName>Ultra HD EBUS FNA Needle, 19 G, 2.0 mm, 0-5 cm, 4.1 Fr, Compatible with Pentax Brand Bronchoscope</deviceName>
    <manufacturerName>ACE MEDICAL DEVICES PVT LTD</manufacturerName>
    <manufacturerSrn>IN-MF-000023786</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A01020102</emdnCode>
    <emdnDescription>ASPIRATION FINE NEEDLES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AEBUS-FNA-19-P</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-25T04:08:17.051Z</lastUpdated>
  </row>
  <row>
    <udiDi>08904148101327</udiDi>
    <basicUdiDi>B-08904148101327</basicUdiDi>
    <tradeName>ACE Ultra HD EBUS FNA Needle, 22 G, 2.0 mm, 0-5 cm, 4.1 Fr, Compatible with Pentax Brand Bronchoscope</tradeName>
    <deviceName>Ultra HD EBUS FNA Needle, 22 G, 2.0 mm, 0-5 cm, 4.1 Fr, Compatible with Pentax Brand Bronchoscope</deviceName>
    <manufacturerName>ACE MEDICAL DEVICES PVT LTD</manufacturerName>
    <manufacturerSrn>IN-MF-000023786</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A01020102</emdnCode>
    <emdnDescription>ASPIRATION FINE NEEDLES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AEBUS-FNA-22-P</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-25T04:08:16.252Z</lastUpdated>
  </row>
  <row>
    <udiDi>08904148100573</udiDi>
    <basicUdiDi>B-08904148100573</basicUdiDi>
    <tradeName>ACE Ultra HD EBUS FNA Needle, 25 G, 2.0 mm, 0-5 cm, 4.1 Fr, Compatible with Olympus/Fujifilm Brand Bronchoscope</tradeName>
    <deviceName>ACE Ultra HD EBUS FNA Needle, 25 G, 2.0 mm, 0-5 cm, 4.1 Fr, Compatible with Olympus/Fujifilm Brand Bronchoscope</deviceName>
    <manufacturerName>ACE MEDICAL DEVICES PVT LTD</manufacturerName>
    <manufacturerSrn>IN-MF-000023786</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A01020102</emdnCode>
    <emdnDescription>ASPIRATION FINE NEEDLES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AEBUS-FNA-25</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-25T04:08:15.455Z</lastUpdated>
  </row>
  <row>
    <udiDi>08904148100559</udiDi>
    <basicUdiDi>B-08904148100559</basicUdiDi>
    <tradeName>ACE Ultra HD EBUS FNA Needle, 22 G, 2.0 mm, 0-5 cm, 4.1 Fr, Compatible with Olympus/ Fujifilm Brand Bronchoscope</tradeName>
    <deviceName>Ultra HD EBUS FNA Needle, 22 G, 2.0 mm, 0-5 cm, 4.1 Fr, Compatible with Olympus/ Fujifilm Bronchoscope</deviceName>
    <manufacturerName>ACE MEDICAL DEVICES PVT LTD</manufacturerName>
    <manufacturerSrn>IN-MF-000023786</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A01020102</emdnCode>
    <emdnDescription>ASPIRATION FINE NEEDLES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AEBUS-FNA-22</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-25T04:08:12.253Z</lastUpdated>
  </row>
  <row>
    <udiDi>08904148100542</udiDi>
    <basicUdiDi>B-08904148100542</basicUdiDi>
    <tradeName>ACE Ultra HD EBUS FNA Needle, 19 G, 2.0 mm, 0-5 cm, 4.1 Fr, Compatible with Olympus/ Fujifilm Brand Bronchoscope</tradeName>
    <deviceName>Ultra HD EBUS FNA Needle,19 G, 2.0 mm, 0-5 cm, 4.1 Fr, Compatible with Olympus/ Fujifilm Brand Bronchoscope</deviceName>
    <manufacturerName>ACE MEDICAL DEVICES PVT LTD</manufacturerName>
    <manufacturerSrn>IN-MF-000023786</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A01020102</emdnCode>
    <emdnDescription>ASPIRATION FINE NEEDLES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AEBUS-FNA-19</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-25T04:08:11.453Z</lastUpdated>
  </row>
  <row>
    <udiDi>08904148100122</udiDi>
    <basicUdiDi>B-08904148100122</basicUdiDi>
    <tradeName>ACE Ultra HD EUS FNA Needle, 25 G, 2.8 mm, 0-8 cm, 5.2 Fr</tradeName>
    <deviceName>Ultra HD EUS FNA Needle, 25 G, 2.8 mm, 0-8 cm, 5.2 Fr</deviceName>
    <manufacturerName>ACE MEDICAL DEVICES PVT LTD</manufacturerName>
    <manufacturerSrn>IN-MF-000023786</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A01020102</emdnCode>
    <emdnDescription>ASPIRATION FINE NEEDLES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AEUS-FNA-25</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-25T04:08:10.652Z</lastUpdated>
  </row>
  <row>
    <udiDi>08904148100092</udiDi>
    <basicUdiDi>B-08904148100092</basicUdiDi>
    <tradeName>ACE Ultra HD EUS FNA Needle, 22 G, 2.8 mm, 0-8 cm, 5.2 Fr</tradeName>
    <deviceName>Ultra HD EUS FNA Needle, 22 G, 2.8 mm, 0-8 cm, 5.2 Fr</deviceName>
    <manufacturerName>ACE MEDICAL DEVICES PVT LTD</manufacturerName>
    <manufacturerSrn>IN-MF-000023786</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A01020102</emdnCode>
    <emdnDescription>ASPIRATION FINE NEEDLES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AEUS-FNA-22</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-25T04:08:07.452Z</lastUpdated>
  </row>
  <row>
    <udiDi>08904148100030</udiDi>
    <basicUdiDi>B-08904148100030</basicUdiDi>
    <tradeName>ACE Ultra HD EUS FNA Needle, 19 G, 2.8 mm, 0-8 cm, 5.2 Fr</tradeName>
    <deviceName>ACE Ultra HD EUS FNA Needle, 19 G, 2.8 mm, 0-8 cm, 5.2 Fr</deviceName>
    <manufacturerName>ACE MEDICAL DEVICES PVT LTD</manufacturerName>
    <manufacturerSrn>IN-MF-000023786</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A01020102</emdnCode>
    <emdnDescription>ASPIRATION FINE NEEDLES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AEUS-FNA-19</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-25T04:08:06.677Z</lastUpdated>
  </row>
  <row>
    <udiDi>04262410680180</udiDi>
    <basicUdiDi>426241068KIRKIM94</basicUdiDi>
    <tradeName>04262410680180</tradeName>
    <deviceName>Coaxial Interventional Needle</deviceName>
    <manufacturerName>ITP Innovative Tomography Products GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000008634</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A01020102</emdnCode>
    <emdnDescription>ASPIRATION FINE NEEDLES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KIM18/15</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T06:21:16.723Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809327352920</udiDi>
    <basicUdiDi>0880932735CTGT</basicUdiDi>
    <tradeName>ClearTip</tradeName>
    <deviceName>Endoscopic Ultrasound-Guided Tissue Acquisition Needle</deviceName>
    <manufacturerName>FINEMEDIX CO., LTD.</manufacturerName>
    <manufacturerSrn>KR-MF-000021680</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A01020102</emdnCode>
    <emdnDescription>ASPIRATION FINE NEEDLES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FM-CTA001</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T04:06:08.784Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850023741097</udiDi>
    <basicUdiDi>08586900068300101G5</basicUdiDi>
    <tradeName>RAN-1113-OT</tradeName>
    <deviceName>Ranfac Bone Marrow Aspiration Needle</deviceName>
    <manufacturerName>Ranfac Corp.</manufacturerName>
    <manufacturerSrn>US-MF-000008871</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A01020102</emdnCode>
    <emdnDescription>ASPIRATION FINE NEEDLES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>74368-01M</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:38:43.736Z</lastUpdated>
  </row>
  <row>
    <udiDi>00827002597426</udiDi>
    <basicUdiDi>0827002CIRL202011039025AY</basicUdiDi>
    <tradeName>EchoTip ClearCore</tradeName>
    <deviceName>EchoTip AcuCore EUS Biopsy Needle</deviceName>
    <manufacturerName>Cook Ireland Limited</manufacturerName>
    <manufacturerSrn>IE-MF-000001530</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A01020102</emdnCode>
    <emdnDescription>ASPIRATION FINE NEEDLES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECHO-BX-19</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:47:12.718Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-802122/15KC</udiDi>
    <basicUdiDi>B-802122/15KC</basicUdiDi>
    <tradeName>D-802122/15KC</tradeName>
    <deviceName>AGO CHIBA ECOGENICO CENTIMETRATO 22G 15cm</deviceName>
    <manufacturerName>MED ITALIA BIOMEDICA S.R.L</manufacturerName>
    <manufacturerSrn>IT-MF-000025272</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A01020102</emdnCode>
    <emdnDescription>ASPIRATION FINE NEEDLES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>802122/15</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:33:55.103Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-802122/09KH</udiDi>
    <basicUdiDi>B-802122/09KH</basicUdiDi>
    <tradeName>D-802122/09KH</tradeName>
    <deviceName>AGO CHIBA ECOGENICO CENTIMETRATO 22G 9cm</deviceName>
    <manufacturerName>MED ITALIA BIOMEDICA S.R.L</manufacturerName>
    <manufacturerSrn>IT-MF-000025272</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A01020102</emdnCode>
    <emdnDescription>ASPIRATION FINE NEEDLES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>802122/09</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:33:54.298Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-802122/20K5</udiDi>
    <basicUdiDi>B-802122/20K5</basicUdiDi>
    <tradeName>D-802122/20K5</tradeName>
    <deviceName>AGO CHIBA ECOGENICO CENTIMETRATO 22G 20cm</deviceName>
    <manufacturerName>MED ITALIA BIOMEDICA S.R.L</manufacturerName>
    <manufacturerSrn>IT-MF-000025272</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A01020102</emdnCode>
    <emdnDescription>ASPIRATION FINE NEEDLES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>802122/20</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:33:52.703Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-802122/07KD</udiDi>
    <basicUdiDi>B-802122/07KD</basicUdiDi>
    <tradeName>D-802122/07KD</tradeName>
    <deviceName>AGO CHIBA ECOGENICO CENTIMETRATO 22G 7cm</deviceName>
    <manufacturerName>MED ITALIA BIOMEDICA S.R.L</manufacturerName>
    <manufacturerSrn>IT-MF-000025272</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A01020102</emdnCode>
    <emdnDescription>ASPIRATION FINE NEEDLES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>802122/07</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:33:35.844Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-802121/20JW</udiDi>
    <basicUdiDi>B-802121/20JW</basicUdiDi>
    <tradeName>D-802121/20JW</tradeName>
    <deviceName>AGO CHIBA ECOGENICO CENTIMETRATO 21G 20cm</deviceName>
    <manufacturerName>MED ITALIA BIOMEDICA S.R.L</manufacturerName>
    <manufacturerSrn>IT-MF-000025272</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A01020102</emdnCode>
    <emdnDescription>ASPIRATION FINE NEEDLES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>802121/20</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:33:35.047Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-802121/15K5</udiDi>
    <basicUdiDi>B-802121/15K5</basicUdiDi>
    <tradeName>D-802121/15K5</tradeName>
    <deviceName>AGO CHIBA ECOGENICO CENTIMETRATO 21G 15cm</deviceName>
    <manufacturerName>MED ITALIA BIOMEDICA S.R.L</manufacturerName>
    <manufacturerSrn>IT-MF-000025272</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A01020102</emdnCode>
    <emdnDescription>ASPIRATION FINE NEEDLES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>802121/15</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:33:34.251Z</lastUpdated>
  </row>
</eudamedExport>