<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>05700002169716</udiDi>
    <basicUdiDi>57000021697SeromaSetFX</basicUdiDi>
    <tradeName>Handset</tradeName>
    <deviceName>Handset</deviceName>
    <manufacturerName>Innoventa Medica ApS</manufacturerName>
    <manufacturerSrn>DK-MF-000013980</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A06010199</emdnCode>
    <emdnDescription>VACUUM AND GRAVITY DRAINAGE SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1050</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-31T08:48:03.279Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250203221382</udiDi>
    <basicUdiDi>42502032PRI0444U</basicUdiDi>
    <tradeName>Geschlossenes Wunddrainagesystem mit J.P.-Flachdrain B = 4 mm,</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Primed Halberstadt Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000004967</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A06010199</emdnCode>
    <emdnDescription>VACUUM AND GRAVITY DRAINAGE SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>24840</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T20:54:05.367Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250203203043</udiDi>
    <basicUdiDi>42502032PRI0464Y</basicUdiDi>
    <tradeName>Passiv-Drainage mit Silikondrain Ch.20, L = 1000 mm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Primed Halberstadt Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000004967</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A06010199</emdnCode>
    <emdnDescription>VACUUM AND GRAVITY DRAINAGE SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>21888</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T20:53:02.867Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250203201957</udiDi>
    <basicUdiDi>42502032PRI0454W</basicUdiDi>
    <tradeName>Aktiv-Passiv-Drainage, Ch.14, mit Universalkonnektor mit Drainagebeutel 500 ml mit Ablasshahn Silikondrain (500/150) mit Trokar steril</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Primed Halberstadt Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000004967</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A06010199</emdnCode>
    <emdnDescription>VACUUM AND GRAVITY DRAINAGE SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>22127</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T20:52:57.261Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250203201797</udiDi>
    <basicUdiDi>42502032PRI0434S</basicUdiDi>
    <tradeName>Pumpkammer-Drainage mit 500 ml Drainagebeutel und Silikondrain 1000 mm Ch.12, steril</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Primed Halberstadt Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000004967</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A06010199</emdnCode>
    <emdnDescription>VACUUM AND GRAVITY DRAINAGE SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>22060</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T20:52:56.458Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250203200448</udiDi>
    <basicUdiDi>42502032PRI0424Q</basicUdiDi>
    <tradeName>PRI-LOW-VAC ® Mini-Set 20 ml, Ch.6 mit Drain (500/150) und Trokar</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Primed Halberstadt Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000004967</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A06010199</emdnCode>
    <emdnDescription>VACUUM AND GRAVITY DRAINAGE SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>21614</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T20:52:29.213Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049047108160</udiDi>
    <basicUdiDi>4049047AAE10CBA27DREN6</basicUdiDi>
    <tradeName>04049047108160</tradeName>
    <deviceName>Monopolar &amp; Bipolar Resectoscope</deviceName>
    <manufacturerName>Gimmi GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005445</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A06010199</emdnCode>
    <emdnDescription>VACUUM AND GRAVITY DRAINAGE SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>T.9537.11</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T19:53:52.259Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972696689439</udiDi>
    <basicUdiDi>B-06972696689439</basicUdiDi>
    <tradeName>Yankauer set</tradeName>
    <deviceName>Yankauer set</deviceName>
    <manufacturerName>Grena (Qingdao) Medical Devices Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009861</manufacturerSrn>
    <authorisedRepresentativeName>MDML Intl Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000001156</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A06010199</emdnCode>
    <emdnDescription>VACUUM AND GRAVITY DRAINAGE SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0202-30006SSXCX30X</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-30T03:54:30.117Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972696688999</udiDi>
    <basicUdiDi>B-06972696688999</basicUdiDi>
    <tradeName>Yankauer set</tradeName>
    <deviceName>Yankauer set</deviceName>
    <manufacturerName>Grena (Qingdao) Medical Devices Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009861</manufacturerSrn>
    <authorisedRepresentativeName>MDML Intl Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000001156</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A06010199</emdnCode>
    <emdnDescription>VACUUM AND GRAVITY DRAINAGE SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0202-21006SSXCX24X</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-30T03:54:29.302Z</lastUpdated>
  </row>
  <row>
    <udiDi>04711182606657</udiDi>
    <basicUdiDi>B-04711182606657</basicUdiDi>
    <tradeName>Silicone Penrose Drain Tube</tradeName>
    <deviceName>Silicone Penrose Drain Tube</deviceName>
    <manufacturerName>FORTUNE MEDICAL INSTRUMENT CORP.</manufacturerName>
    <manufacturerSrn>TW-MF-000009221</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A06010199</emdnCode>
    <emdnDescription>VACUUM AND GRAVITY DRAINAGE SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2010-1415</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-27T03:39:51.310Z</lastUpdated>
  </row>
  <row>
    <udiDi>04711182604875</udiDi>
    <basicUdiDi>B-04711182604875</basicUdiDi>
    <tradeName>Silicone Penrose Drain Tube W/ Secure-Clip</tradeName>
    <deviceName>Silicone Penrose Drain Tube W/ Secure-Clip</deviceName>
    <manufacturerName>FORTUNE MEDICAL INSTRUMENT CORP.</manufacturerName>
    <manufacturerSrn>TW-MF-000009221</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A06010199</emdnCode>
    <emdnDescription>VACUUM AND GRAVITY DRAINAGE SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2010-5419</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-27T03:39:45.708Z</lastUpdated>
  </row>
  <row>
    <udiDi>04711182604868</udiDi>
    <basicUdiDi>B-04711182604868</basicUdiDi>
    <tradeName>Silicone Penrose Drain Tube W/ Secure-Clip</tradeName>
    <deviceName>Silicone Penrose Drain Tube W/ Secure-Clip</deviceName>
    <manufacturerName>FORTUNE MEDICAL INSTRUMENT CORP.</manufacturerName>
    <manufacturerSrn>TW-MF-000009221</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A06010199</emdnCode>
    <emdnDescription>VACUUM AND GRAVITY DRAINAGE SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2010-5415</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-27T03:39:44.927Z</lastUpdated>
  </row>
  <row>
    <udiDi>04711182604882</udiDi>
    <basicUdiDi>B-04711182604882</basicUdiDi>
    <tradeName>Silicone Penrose Drain Tube W/ Secure-Clip</tradeName>
    <deviceName>Silicone Penrose Drain Tube W/ Secure-Clip</deviceName>
    <manufacturerName>FORTUNE MEDICAL INSTRUMENT CORP.</manufacturerName>
    <manufacturerSrn>TW-MF-000009221</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A06010199</emdnCode>
    <emdnDescription>VACUUM AND GRAVITY DRAINAGE SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2010-5419</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-27T03:39:43.414Z</lastUpdated>
  </row>
  <row>
    <udiDi>04711182604844</udiDi>
    <basicUdiDi>B-04711182604844</basicUdiDi>
    <tradeName>Silicone Penrose Drain Tube W/ Secure-Clip</tradeName>
    <deviceName>Silicone Penrose Drain Tube W/ Secure-Clip</deviceName>
    <manufacturerName>FORTUNE MEDICAL INSTRUMENT CORP.</manufacturerName>
    <manufacturerSrn>TW-MF-000009221</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A06010199</emdnCode>
    <emdnDescription>VACUUM AND GRAVITY DRAINAGE SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2010-5410</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-27T03:39:26.458Z</lastUpdated>
  </row>
  <row>
    <udiDi>04711182604820</udiDi>
    <basicUdiDi>B-04711182604820</basicUdiDi>
    <tradeName>Silicone Penrose Drain Tube W/ Secure-Clip</tradeName>
    <deviceName>Silicone Penrose Drain Tube W/ Secure-Clip</deviceName>
    <manufacturerName>FORTUNE MEDICAL INSTRUMENT CORP.</manufacturerName>
    <manufacturerSrn>TW-MF-000009221</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A06010199</emdnCode>
    <emdnDescription>VACUUM AND GRAVITY DRAINAGE SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2010-5406</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-27T03:39:25.661Z</lastUpdated>
  </row>
  <row>
    <udiDi>04711182604813</udiDi>
    <basicUdiDi>B-04711182604813</basicUdiDi>
    <tradeName>Silicone Penrose Drain Tube W/ Secure-Clip</tradeName>
    <deviceName>Silicone Penrose Drain Tube W/ Secure-Clip</deviceName>
    <manufacturerName>FORTUNE MEDICAL INSTRUMENT CORP.</manufacturerName>
    <manufacturerSrn>TW-MF-000009221</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A06010199</emdnCode>
    <emdnDescription>VACUUM AND GRAVITY DRAINAGE SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2010-5405</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-27T03:39:24.845Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710961934615</udiDi>
    <basicUdiDi>B-04710961934615</basicUdiDi>
    <tradeName>Silicone Penrose Drain Tube</tradeName>
    <deviceName>Silicone Penrose Drain Tube</deviceName>
    <manufacturerName>FORTUNE MEDICAL INSTRUMENT CORP.</manufacturerName>
    <manufacturerSrn>TW-MF-000009221</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A06010199</emdnCode>
    <emdnDescription>VACUUM AND GRAVITY DRAINAGE SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2010-1406</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-27T03:39:06.437Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710961934608</udiDi>
    <basicUdiDi>B-04710961934608</basicUdiDi>
    <tradeName>Silicone Penrose Drain Tube</tradeName>
    <deviceName>Silicone Penrose Drain Tube</deviceName>
    <manufacturerName>FORTUNE MEDICAL INSTRUMENT CORP.</manufacturerName>
    <manufacturerSrn>TW-MF-000009221</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A06010199</emdnCode>
    <emdnDescription>VACUUM AND GRAVITY DRAINAGE SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2010-1405</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-27T03:39:05.641Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972696689200</udiDi>
    <basicUdiDi>B-06972696689200</basicUdiDi>
    <tradeName>Yankauer set</tradeName>
    <deviceName>Yankauer set</deviceName>
    <manufacturerName>Grena (Qingdao) Medical Devices Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009861</manufacturerSrn>
    <authorisedRepresentativeName>MDML Intl Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000001156</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A06010199</emdnCode>
    <emdnDescription>VACUUM AND GRAVITY DRAINAGE SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0202-21006SSXSH28X</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T16:11:31.537Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250203225649</udiDi>
    <basicUdiDi>42502032PRI0164P</basicUdiDi>
    <tradeName>OPTILINE® Einflaschenset mit 3.000 ml Flasche Patientenschlauch 1,8 m mit Trichterende</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Primed Halberstadt Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000004967</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A06010199</emdnCode>
    <emdnDescription>VACUUM AND GRAVITY DRAINAGE SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>27134</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T05:52:30.135Z</lastUpdated>
  </row>
</eudamedExport>