<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08800042100261</udiDi>
    <basicUdiDi>B-08800042100261</basicUdiDi>
    <tradeName>ANTIGE</tradeName>
    <deviceName>Electrosurgical Unit and Sterile Disposable Electrode</deviceName>
    <manufacturerName>AMI INC.</manufacturerName>
    <manufacturerSrn>KR-MF-000017522</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12010902</emdnCode>
    <emdnDescription>ELECTROSURGICAL UNITS (ESU) FOR GENERAL USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AMI-CL-0911</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-09T22:26:36.820Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800042100278</udiDi>
    <basicUdiDi>B-08800042100278</basicUdiDi>
    <tradeName>MT-SMART</tradeName>
    <deviceName>Electrosurgical Unit and Sterile Disposable Electrode</deviceName>
    <manufacturerName>AMI INC.</manufacturerName>
    <manufacturerSrn>KR-MF-000017522</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12010902</emdnCode>
    <emdnDescription>ELECTROSURGICAL UNITS (ESU) FOR GENERAL USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AMI-CL-0941</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-09T22:26:34.419Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800020101785</udiDi>
    <basicUdiDi>B-08800020101785</basicUdiDi>
    <tradeName>POTENZA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jeisys Medical Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000008513</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12010902</emdnCode>
    <emdnDescription>ELECTROSURGICAL UNITS (ESU) FOR GENERAL USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>16</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-09T17:05:49.568Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800009400489</udiDi>
    <basicUdiDi>B-08800009400489</basicUdiDi>
    <tradeName>Daiwha Corp., Ltd.</tradeName>
    <deviceName>DE-400E</deviceName>
    <manufacturerName>Daiwha Corp., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000024402</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12010902</emdnCode>
    <emdnDescription>ELECTROSURGICAL UNITS (ESU) FOR GENERAL USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DW-MTS</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T16:31:33.429Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800009400458</udiDi>
    <basicUdiDi>B-08800009400458</basicUdiDi>
    <tradeName>Daiwha Corp., Ltd.</tradeName>
    <deviceName>DUB-100</deviceName>
    <manufacturerName>Daiwha Corp., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000024402</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12010902</emdnCode>
    <emdnDescription>ELECTROSURGICAL UNITS (ESU) FOR GENERAL USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DW-MTS</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T16:31:14.162Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800009400359</udiDi>
    <basicUdiDi>B-08800009400359</basicUdiDi>
    <tradeName>Daiwha Corp., Ltd.</tradeName>
    <deviceName>DT-150S</deviceName>
    <manufacturerName>Daiwha Corp., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000024402</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12010902</emdnCode>
    <emdnDescription>ELECTROSURGICAL UNITS (ESU) FOR GENERAL USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DW-MTS</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T16:31:05.349Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800009400342</udiDi>
    <basicUdiDi>B-08800009400342</basicUdiDi>
    <tradeName>Daiwha Corp., Ltd.</tradeName>
    <deviceName>DT-200S</deviceName>
    <manufacturerName>Daiwha Corp., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000024402</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12010902</emdnCode>
    <emdnDescription>ELECTROSURGICAL UNITS (ESU) FOR GENERAL USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DW-MTS</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T16:31:01.356Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800009400335</udiDi>
    <basicUdiDi>B-08800009400335</basicUdiDi>
    <tradeName>Daiwha Corp., Ltd.</tradeName>
    <deviceName>DT-300S</deviceName>
    <manufacturerName>Daiwha Corp., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000024402</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12010902</emdnCode>
    <emdnDescription>ELECTROSURGICAL UNITS (ESU) FOR GENERAL USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DW-MTS</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T16:31:00.548Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800009400328</udiDi>
    <basicUdiDi>B-08800009400328</basicUdiDi>
    <tradeName>08800009400328</tradeName>
    <deviceName>DT-400S</deviceName>
    <manufacturerName>Daiwha Corp., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000024402</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12010902</emdnCode>
    <emdnDescription>ELECTROSURGICAL UNITS (ESU) FOR GENERAL USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DW-MTS</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T16:30:59.752Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800009400311</udiDi>
    <basicUdiDi>B-08800009400311</basicUdiDi>
    <tradeName>DAIWHA Corp., Ltd.</tradeName>
    <deviceName>DE-400</deviceName>
    <manufacturerName>Daiwha Corp., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000024402</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12010902</emdnCode>
    <emdnDescription>ELECTROSURGICAL UNITS (ESU) FOR GENERAL USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DW-TWS</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T16:30:58.962Z</lastUpdated>
  </row>
  <row>
    <udiDi>08053435980005</udiDi>
    <basicUdiDi>B-08053435980005</basicUdiDi>
    <tradeName>08053435980005</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OTECH INDUSTRY SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000029975</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12010902</emdnCode>
    <emdnDescription>ELECTROSURGICAL UNITS (ESU) FOR GENERAL USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A 1000</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T16:51:49.892Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060359560698</udiDi>
    <basicUdiDi>B-05060359560698</basicUdiDi>
    <tradeName>CROMA Electrosurgical Generator</tradeName>
    <deviceName>CROMA Electrosurgical Generator (PG2.0)</deviceName>
    <manufacturerName>Creo Medical</manufacturerName>
    <manufacturerSrn>GB-MF-000019076</manufacturerSrn>
    <authorisedRepresentativeName>Creo Medical, S.L.U.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001355</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12010902</emdnCode>
    <emdnDescription>ELECTROSURGICAL UNITS (ESU) FOR GENERAL USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PRD-EMR-050</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T05:24:06.393Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050147015753</udiDi>
    <basicUdiDi>B-04050147015753</basicUdiDi>
    <tradeName>Zweipedal-Fußschalter; VIO® 3</tradeName>
    <deviceName>Footswitch, electrosurgery stystems</deviceName>
    <manufacturerName>Erbe Elektromedizin GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005498</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12010902</emdnCode>
    <emdnDescription>ELECTROSURGICAL UNITS (ESU) FOR GENERAL USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20189-353</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:38:06.819Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050147015746</udiDi>
    <basicUdiDi>B-04050147015746</basicUdiDi>
    <tradeName>Zweipedal-Fußschalter; VIO® 3</tradeName>
    <deviceName>Footswitch, electrosurgery stystems</deviceName>
    <manufacturerName>Erbe Elektromedizin GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005498</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12010902</emdnCode>
    <emdnDescription>ELECTROSURGICAL UNITS (ESU) FOR GENERAL USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20189-350</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:38:06.021Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050147015722</udiDi>
    <basicUdiDi>B-04050147015722</basicUdiDi>
    <tradeName>Zweipedal-Fußschalter; VIO® 3</tradeName>
    <deviceName>Footswitch, electrosurgery stystems</deviceName>
    <manufacturerName>Erbe Elektromedizin GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005498</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12010902</emdnCode>
    <emdnDescription>ELECTROSURGICAL UNITS (ESU) FOR GENERAL USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20189-352</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:38:01.228Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050147015715</udiDi>
    <basicUdiDi>B-04050147015715</basicUdiDi>
    <tradeName>Zweipedal-Fußschalter; VIO® 3</tradeName>
    <deviceName>Footswitch, electrosurgery stystems</deviceName>
    <manufacturerName>Erbe Elektromedizin GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005498</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12010902</emdnCode>
    <emdnDescription>ELECTROSURGICAL UNITS (ESU) FOR GENERAL USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20189-351</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:38:00.421Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050147015708</udiDi>
    <basicUdiDi>B-04050147015708</basicUdiDi>
    <tradeName>Einpedal-Fußschalter; VIO® 3</tradeName>
    <deviceName>Footswitch, electrosurgery stystems</deviceName>
    <manufacturerName>Erbe Elektromedizin GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005498</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12010902</emdnCode>
    <emdnDescription>ELECTROSURGICAL UNITS (ESU) FOR GENERAL USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20188-350</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:37:59.616Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050147015401</udiDi>
    <basicUdiDi>B-04050147015401</basicUdiDi>
    <tradeName>2 Pedal-Fußsch. VIO®; ReMode®</tradeName>
    <deviceName>Footswitch, electrosurgery stystems</deviceName>
    <manufacturerName>Erbe Elektromedizin GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005498</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12010902</emdnCode>
    <emdnDescription>ELECTROSURGICAL UNITS (ESU) FOR GENERAL USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20189-305</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:37:58.829Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050147015395</udiDi>
    <basicUdiDi>B-04050147015395</basicUdiDi>
    <tradeName>Zweipedal-Fußschalter VIO®</tradeName>
    <deviceName>Footswitch, electrosurgery stystems</deviceName>
    <manufacturerName>Erbe Elektromedizin GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005498</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12010902</emdnCode>
    <emdnDescription>ELECTROSURGICAL UNITS (ESU) FOR GENERAL USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20189-304</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:37:54.827Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050147015388</udiDi>
    <basicUdiDi>B-04050147015388</basicUdiDi>
    <tradeName>Einpedal-Fußschalter VIO®</tradeName>
    <deviceName>Footswitch, electrosurgery stystems</deviceName>
    <manufacturerName>Erbe Elektromedizin GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005498</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12010902</emdnCode>
    <emdnDescription>ELECTROSURGICAL UNITS (ESU) FOR GENERAL USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20188-301</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:37:54.013Z</lastUpdated>
  </row>
</eudamedExport>