<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>15060391210619</udiDi>
    <basicUdiDi>506039121SentimagDK</basicUdiDi>
    <tradeName>Sentimag Probe</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Endomagnetics Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000007233</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A019012</emdnCode>
    <emdnDescription>BREAST NODULES AND OTHER STRUCTURES LOCALISATION NEEDLES AND SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R-SMP02</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:41:54.977Z</lastUpdated>
  </row>
  <row>
    <udiDi>15060391210626</udiDi>
    <basicUdiDi>506039121SentimagDK</basicUdiDi>
    <tradeName>Sentimag Base Unit Gen3</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Endomagnetics Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000007233</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A019012</emdnCode>
    <emdnDescription>BREAST NODULES AND OTHER STRUCTURES LOCALISATION NEEDLES AND SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R-SMB03</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:41:52.229Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260146684410</udiDi>
    <basicUdiDi>426014668KANUELE038J</basicUdiDi>
    <tradeName>Knopfkanüle</tradeName>
    <deviceName>Knopfkanüle</deviceName>
    <manufacturerName>Radimed Gesellschaft für Kommunikationsdienstleistungen und Medizintechnik mbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006540</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A019001</emdnCode>
    <emdnDescription>BLUNT NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10210</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-23T04:01:17.104Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260146680221</udiDi>
    <basicUdiDi>426014668KANUELE018E</basicUdiDi>
    <tradeName>Feinnadel zur Schmerztherapie</tradeName>
    <deviceName>Feinnadeln / IMS</deviceName>
    <manufacturerName>Radimed Gesellschaft für Kommunikationsdienstleistungen und Medizintechnik mbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006540</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A019099</emdnCode>
    <emdnDescription>NEEDLES FOR OTHER PROCEDURES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10003</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-23T04:01:15.491Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936899510631</udiDi>
    <basicUdiDi>69368995SL130ZG</basicUdiDi>
    <tradeName>06936899510631</tradeName>
    <deviceName>Disposable Press Needles</deviceName>
    <manufacturerName>Wujiang City Shenlong Medical Health Product Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017191</manufacturerSrn>
    <authorisedRepresentativeName>Caretechion GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005946</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A019002</emdnCode>
    <emdnDescription>ACUPUNCTURE NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A019002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:04:15.923Z</lastUpdated>
  </row>
  <row>
    <udiDi>04251610640322</udiDi>
    <basicUdiDi>42516106SaugkanuelenVG</basicUdiDi>
    <tradeName>OP-Sauger 14: 6,00 x 55 mm, gerade, 10x5 Bohrungen, mit Innenrohr, vorn geschlossen,</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Robert Helwig GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000012987</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A019009</emdnCode>
    <emdnDescription>DRAINAGE NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>78600055-14</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T16:48:37.607Z</lastUpdated>
  </row>
  <row>
    <udiDi>04251610640377</udiDi>
    <basicUdiDi>42516106SaugkanuelenVG</basicUdiDi>
    <tradeName>OP-Sauger 2,00 x 147 mm, Form 3, Luer-Lock</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Robert Helwig GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000012987</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A019009</emdnCode>
    <emdnDescription>DRAINAGE NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>79200148-3</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-21T16:48:08.209Z</lastUpdated>
  </row>
  <row>
    <udiDi>04251610640384</udiDi>
    <basicUdiDi>42516106SaugkanuelenVG</basicUdiDi>
    <tradeName>OP-Sauger 2,50 x 147 mm, Form 4, Luer-Lock</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Robert Helwig GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000012987</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A019009</emdnCode>
    <emdnDescription>DRAINAGE NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>79250152-4</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-21T16:48:08.183Z</lastUpdated>
  </row>
  <row>
    <udiDi>04251610640391</udiDi>
    <basicUdiDi>42516106SaugkanuelenVG</basicUdiDi>
    <tradeName>OP-Sauger 2,50 x 147 mm, Form 5, Luer-Lock</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Robert Helwig GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000012987</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A019009</emdnCode>
    <emdnDescription>DRAINAGE NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>79250153-5</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-21T16:48:08.161Z</lastUpdated>
  </row>
  <row>
    <udiDi>04251610640407</udiDi>
    <basicUdiDi>42516106SaugkanuelenVG</basicUdiDi>
    <tradeName>OP-Sauger 2,50 x 147 mm, Form 6, Luer-Lock</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Robert Helwig GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000012987</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A019009</emdnCode>
    <emdnDescription>DRAINAGE NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>79250149-6</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-21T16:48:08.134Z</lastUpdated>
  </row>
  <row>
    <udiDi>04251610640414</udiDi>
    <basicUdiDi>42516106SaugkanuelenVG</basicUdiDi>
    <tradeName>OP-Sauger 2: 3,00 x 160 mm, gebogen, Knopf mit Bohrungen, Griff mit Schlauchanschluss</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Robert Helwig GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000012987</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A019009</emdnCode>
    <emdnDescription>DRAINAGE NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>78300160-02</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-21T16:48:08.107Z</lastUpdated>
  </row>
  <row>
    <udiDi>04251610640421</udiDi>
    <basicUdiDi>42516106SaugkanuelenVG</basicUdiDi>
    <tradeName>OP-Sauger 21: 6,50 x 37,50 mm, gerade, 8x7 Bohrungen, mit Innenrohr, vorn geschlossen,</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Robert Helwig GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000012987</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A019009</emdnCode>
    <emdnDescription>DRAINAGE NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>78650037.5-21</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-21T16:48:08.082Z</lastUpdated>
  </row>
  <row>
    <udiDi>04251610640438</udiDi>
    <basicUdiDi>42516106SaugkanuelenVG</basicUdiDi>
    <tradeName>OP-Sauger 22: 6,50 x 37,50 mm, gerade, 8x7 Bohrungen, vorn geschlossen,</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Robert Helwig GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000012987</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A019009</emdnCode>
    <emdnDescription>DRAINAGE NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>78650037.5-22</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-21T16:48:08.056Z</lastUpdated>
  </row>
  <row>
    <udiDi>04251610640445</udiDi>
    <basicUdiDi>42516106SaugkanuelenVG</basicUdiDi>
    <tradeName>OP-Sauger 23: 5,00 x 23,80 mm, gerade, 28 Bohrungen, mit Innenrohr, vorn geschlossen,</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Robert Helwig GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000012987</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A019009</emdnCode>
    <emdnDescription>DRAINAGE NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>78500023.8-23</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-21T16:48:08.032Z</lastUpdated>
  </row>
  <row>
    <udiDi>04251610640452</udiDi>
    <basicUdiDi>42516106SaugkanuelenVG</basicUdiDi>
    <tradeName>OP-Sauger 24: 5,00 x 23,80 mm, gerade, 28 Bohrungen, vorn geschlossen,</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Robert Helwig GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000012987</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A019009</emdnCode>
    <emdnDescription>DRAINAGE NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>78500023.8-24</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-21T16:48:08.010Z</lastUpdated>
  </row>
  <row>
    <udiDi>04251610640476</udiDi>
    <basicUdiDi>42516106SaugkanuelenVG</basicUdiDi>
    <tradeName>OP-Sauger 3,00 x 147 mm, Form 7, Luer-Lock</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Robert Helwig GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000012987</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A019009</emdnCode>
    <emdnDescription>DRAINAGE NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>79300155-7</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-21T16:48:07.993Z</lastUpdated>
  </row>
  <row>
    <udiDi>04251610640483</udiDi>
    <basicUdiDi>42516106SaugkanuelenVG</basicUdiDi>
    <tradeName>OP-Sauger 3,50 x 140 mm, Form 9, Luer-Lock</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Robert Helwig GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000012987</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A019009</emdnCode>
    <emdnDescription>DRAINAGE NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>79350141-9</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-21T16:48:07.978Z</lastUpdated>
  </row>
  <row>
    <udiDi>04251610640490</udiDi>
    <basicUdiDi>42516106SaugkanuelenVG</basicUdiDi>
    <tradeName>OP-Sauger 3,50 x 154 mm, Form 12, Luer-Lock</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Robert Helwig GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000012987</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A019009</emdnCode>
    <emdnDescription>DRAINAGE NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>79350158-12</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-21T16:48:07.955Z</lastUpdated>
  </row>
  <row>
    <udiDi>04251610640506</udiDi>
    <basicUdiDi>42516106SaugkanuelenVG</basicUdiDi>
    <tradeName>OP-Sauger 3,50 x 147 mm, Form 8, Luer-Lock</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Robert Helwig GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000012987</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A019009</emdnCode>
    <emdnDescription>DRAINAGE NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>79350158-8</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-21T16:48:07.933Z</lastUpdated>
  </row>
  <row>
    <udiDi>04251610640513</udiDi>
    <basicUdiDi>42516106SaugkanuelenVG</basicUdiDi>
    <tradeName>OP-Sauger 3: 2,50 x 95 mm, gebogen, Knopf mit seitl. Bohrungen, Griff mit Schlauchanschluss</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Robert Helwig GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000012987</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A019009</emdnCode>
    <emdnDescription>DRAINAGE NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>78250095-03</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-21T16:48:07.910Z</lastUpdated>
  </row>
</eudamedExport>