<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08800038026421</udiDi>
    <basicUdiDi>B-08800038026421</basicUdiDi>
    <tradeName>EZX</tradeName>
    <deviceName>Powered surgical handpiece system</deviceName>
    <manufacturerName>IMEDICOM Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000002344</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12130580</emdnCode>
    <emdnDescription>MOTORISED ORTHOPAEDIC SURGERY SYSTEM INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H-CAT-010-US-01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-06T22:28:49.789Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800038026414</udiDi>
    <basicUdiDi>B-08800038026414</basicUdiDi>
    <tradeName>EZX</tradeName>
    <deviceName>Powered surgical handpiece system</deviceName>
    <manufacturerName>IMEDICOM Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000002344</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12130580</emdnCode>
    <emdnDescription>MOTORISED ORTHOPAEDIC SURGERY SYSTEM INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H-CAT-010-US-01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-06T22:28:48.985Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800038026407</udiDi>
    <basicUdiDi>B-08800038026407</basicUdiDi>
    <tradeName>EZX</tradeName>
    <deviceName>Powered surgical handpiece system</deviceName>
    <manufacturerName>IMEDICOM Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000002344</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12130580</emdnCode>
    <emdnDescription>MOTORISED ORTHOPAEDIC SURGERY SYSTEM INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H-CAT-010-US-01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-06T22:28:48.189Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800038026391</udiDi>
    <basicUdiDi>B-08800038026391</basicUdiDi>
    <tradeName>EZX</tradeName>
    <deviceName></deviceName>
    <manufacturerName>IMEDICOM Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000002344</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12130580</emdnCode>
    <emdnDescription>MOTORISED ORTHOPAEDIC SURGERY SYSTEM INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H-CAT-010-US-01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-06T22:26:55.061Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800038026384</udiDi>
    <basicUdiDi>B-08800038026384</basicUdiDi>
    <tradeName>EZX</tradeName>
    <deviceName></deviceName>
    <manufacturerName>IMEDICOM Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000002344</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12130580</emdnCode>
    <emdnDescription>MOTORISED ORTHOPAEDIC SURGERY SYSTEM INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H-CAT-010-US-01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-06T22:26:54.254Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800038026377</udiDi>
    <basicUdiDi>B-08800038026377</basicUdiDi>
    <tradeName>EZX</tradeName>
    <deviceName></deviceName>
    <manufacturerName>IMEDICOM Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000002344</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12130580</emdnCode>
    <emdnDescription>MOTORISED ORTHOPAEDIC SURGERY SYSTEM INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H-CAT-010-US-01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-06T22:26:53.463Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800038026360</udiDi>
    <basicUdiDi>B-08800038026360</basicUdiDi>
    <tradeName>EZX</tradeName>
    <deviceName></deviceName>
    <manufacturerName>IMEDICOM Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000002344</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12130580</emdnCode>
    <emdnDescription>MOTORISED ORTHOPAEDIC SURGERY SYSTEM INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H-CAT-010-US-01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-06T22:26:52.753Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800038026353</udiDi>
    <basicUdiDi>B-08800038026353</basicUdiDi>
    <tradeName>EZX</tradeName>
    <deviceName></deviceName>
    <manufacturerName>IMEDICOM Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000002344</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12130580</emdnCode>
    <emdnDescription>MOTORISED ORTHOPAEDIC SURGERY SYSTEM INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H-CAT-010-US-01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-06T22:26:40.554Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800038026346</udiDi>
    <basicUdiDi>B-08800038026346</basicUdiDi>
    <tradeName>08800038026346</tradeName>
    <deviceName></deviceName>
    <manufacturerName>IMEDICOM Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000002344</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12130580</emdnCode>
    <emdnDescription>MOTORISED ORTHOPAEDIC SURGERY SYSTEM INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H-CAT-010-US-01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-06T22:26:39.751Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800038026339</udiDi>
    <basicUdiDi>B-08800038026339</basicUdiDi>
    <tradeName>EZX</tradeName>
    <deviceName>Powered surgical handpiece system</deviceName>
    <manufacturerName>IMEDICOM Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000002344</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12130580</emdnCode>
    <emdnDescription>MOTORISED ORTHOPAEDIC SURGERY SYSTEM INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H-CAT-010-US-01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-06T22:26:38.971Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800038026322</udiDi>
    <basicUdiDi>B-08800038026322</basicUdiDi>
    <tradeName>EZX</tradeName>
    <deviceName>Powered surgical handpiece system</deviceName>
    <manufacturerName>IMEDICOM Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000002344</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12130580</emdnCode>
    <emdnDescription>MOTORISED ORTHOPAEDIC SURGERY SYSTEM INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H-CAT-010-US-01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-06T22:26:38.170Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809288935736</udiDi>
    <basicUdiDi>B-08809288935736</basicUdiDi>
    <tradeName>Saw Blade</tradeName>
    <deviceName>Sterile single use surgical blades</deviceName>
    <manufacturerName>IMEDICOM Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000002344</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12130585</emdnCode>
    <emdnDescription>MOTORISED ORTHOPAEDIC SURGERY SYSTEM INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CAR-BLADE-03</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-08-06T05:28:29.276Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800038032255</udiDi>
    <basicUdiDi>B-08800038032255</basicUdiDi>
    <tradeName>EZX</tradeName>
    <deviceName>Powered surgical handpiece system</deviceName>
    <manufacturerName>IMEDICOM Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000002344</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12130580</emdnCode>
    <emdnDescription>MOTORISED ORTHOPAEDIC SURGERY SYSTEM INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H-CAT-010-US-01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-06T05:28:08.395Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800038032248</udiDi>
    <basicUdiDi>B-08800038032248</basicUdiDi>
    <tradeName>EZX</tradeName>
    <deviceName>Powered surgical handpiece system</deviceName>
    <manufacturerName>IMEDICOM Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000002344</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12130580</emdnCode>
    <emdnDescription>MOTORISED ORTHOPAEDIC SURGERY SYSTEM INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H-CAT-010-US-01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-06T05:28:04.377Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809317171456</udiDi>
    <basicUdiDi>B-08809317171456</basicUdiDi>
    <tradeName>MEDINAUT-V</tradeName>
    <deviceName>Vertebral Augmentation System</deviceName>
    <manufacturerName>IMEDICOM Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000002344</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K010302</emdnCode>
    <emdnDescription>MINIMALLY INVASIVE SPINAL SURGERY INSTRUMENTS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H-CAT-004-US-01</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-06T04:46:11.245Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809317171449</udiDi>
    <basicUdiDi>B-08809317171449</basicUdiDi>
    <tradeName>MEDINAUT-V</tradeName>
    <deviceName>Vertebral Augmentation System</deviceName>
    <manufacturerName>IMEDICOM Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000002344</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K010302</emdnCode>
    <emdnDescription>MINIMALLY INVASIVE SPINAL SURGERY INSTRUMENTS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H-CAT-004-US-01</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-06T04:46:10.446Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809317171432</udiDi>
    <basicUdiDi>B-08809317171432</basicUdiDi>
    <tradeName>MEDINAUT-V</tradeName>
    <deviceName>Vertebral Augmentation System</deviceName>
    <manufacturerName>IMEDICOM Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000002344</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K010302</emdnCode>
    <emdnDescription>MINIMALLY INVASIVE SPINAL SURGERY INSTRUMENTS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H-CAT-004-US-01</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-06T04:46:09.646Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809317171425</udiDi>
    <basicUdiDi>B-08809317171425</basicUdiDi>
    <tradeName>MEDINAUT-V</tradeName>
    <deviceName>Vertebral Augmentation System</deviceName>
    <manufacturerName>IMEDICOM Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000002344</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K010302</emdnCode>
    <emdnDescription>MINIMALLY INVASIVE SPINAL SURGERY INSTRUMENTS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H-CAT-004-US-01</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-06T04:46:08.849Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809317171418</udiDi>
    <basicUdiDi>B-08809317171418</basicUdiDi>
    <tradeName>MEDINAUT-V</tradeName>
    <deviceName>Vertebral Augmentation System</deviceName>
    <manufacturerName>IMEDICOM Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000002344</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K010302</emdnCode>
    <emdnDescription>MINIMALLY INVASIVE SPINAL SURGERY INSTRUMENTS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H-CAT-004-US-01</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-06T04:46:04.931Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809317171401</udiDi>
    <basicUdiDi>B-08809317171401</basicUdiDi>
    <tradeName>MEDINAUT-V</tradeName>
    <deviceName>Vertebral Augmentation System</deviceName>
    <manufacturerName>IMEDICOM Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000002344</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K010302</emdnCode>
    <emdnDescription>MINIMALLY INVASIVE SPINAL SURGERY INSTRUMENTS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H-CAT-004-US-01</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-06T04:46:03.247Z</lastUpdated>
  </row>
</eudamedExport>