<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08809544174312</udiDi>
    <basicUdiDi>B-08809544174312</basicUdiDi>
    <tradeName>MEDINAUT Plus, SteriSpine VA</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>K010301</emdnCode>
    <emdnDescription>SPINAL PERCUTANEOUS PLASTIC DEVICES WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CAR-PIBE-40</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-07T04:55:44.914Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809544174305</udiDi>
    <basicUdiDi>B-08809544174305</basicUdiDi>
    <tradeName>MEDINAUT Plus, SteriSpine VA</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>K010301</emdnCode>
    <emdnDescription>SPINAL PERCUTANEOUS PLASTIC DEVICES WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CAR-PIBE-40</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-07T04:55:41.137Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809544174299</udiDi>
    <basicUdiDi>B-08809544174299</basicUdiDi>
    <tradeName>MEDINAUT Plus, SteriSpine VA</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>K010301</emdnCode>
    <emdnDescription>SPINAL PERCUTANEOUS PLASTIC DEVICES WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CAR-PIBE-40</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-07T04:55:40.128Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809544174282</udiDi>
    <basicUdiDi>B-08809544174282</basicUdiDi>
    <tradeName>MEDINAUT Plus, SteriSpine VA</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>K010301</emdnCode>
    <emdnDescription>SPINAL PERCUTANEOUS PLASTIC DEVICES WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CAR-PIBE-40</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-07T04:55:39.319Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809544174275</udiDi>
    <basicUdiDi>B-08809544174275</basicUdiDi>
    <tradeName>MEDINAUT Plus, SteriSpine VA</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>K010301</emdnCode>
    <emdnDescription>SPINAL PERCUTANEOUS PLASTIC DEVICES WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CAR-PIBE-40</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-07T04:55:38.986Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809544174268</udiDi>
    <basicUdiDi>B-08809544174268</basicUdiDi>
    <tradeName>MEDINAUT Plus, SteriSpine VA</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>K010301</emdnCode>
    <emdnDescription>SPINAL PERCUTANEOUS PLASTIC DEVICES WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CAR-PIBE-40</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-07T04:55:34.497Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809544174251</udiDi>
    <basicUdiDi>B-08809544174251</basicUdiDi>
    <tradeName>MEDINAUT Plus, SteriSpine VA</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>K010301</emdnCode>
    <emdnDescription>SPINAL PERCUTANEOUS PLASTIC DEVICES WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CAR-PIBE-40</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-07T04:55:33.699Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809544174244</udiDi>
    <basicUdiDi>B-08809544174244</basicUdiDi>
    <tradeName>MEDINAUT Plus, SteriSpine VA</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>K010301</emdnCode>
    <emdnDescription>SPINAL PERCUTANEOUS PLASTIC DEVICES WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CAR-PIBE-40</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-07T04:55:32.908Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809544174237</udiDi>
    <basicUdiDi>B-08809544174237</basicUdiDi>
    <tradeName>MEDINAUT Plus, SteriSpine VA</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>K010301</emdnCode>
    <emdnDescription>SPINAL PERCUTANEOUS PLASTIC DEVICES WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CAR-PIBE-40</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-07T04:55:32.124Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809544174220</udiDi>
    <basicUdiDi>B-08809544174220</basicUdiDi>
    <tradeName>MEDINAUT Plus, SteriSpine VA</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>K010301</emdnCode>
    <emdnDescription>SPINAL PERCUTANEOUS PLASTIC DEVICES WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CAR-PIBE-40</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-07T04:55:27.304Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809288939079</udiDi>
    <basicUdiDi>B-08809288939079</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>2026-08-07T04:55:26.506Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809288939062</udiDi>
    <basicUdiDi>B-08809288939062</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>2026-08-07T04:55:25.700Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809288938218</udiDi>
    <basicUdiDi>B-08809288938218</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>2026-08-07T04:55:24.898Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809288938201</udiDi>
    <basicUdiDi>B-08809288938201</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>2026-08-07T04:55:20.900Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809288938195</udiDi>
    <basicUdiDi>B-08809288938195</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>2026-08-07T04:55:20.115Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809288938188</udiDi>
    <basicUdiDi>B-08809288938188</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>2026-08-07T04:55:19.299Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809288936818</udiDi>
    <basicUdiDi>B-08809288936818</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>2026-08-07T04:55:18.530Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809288936801</udiDi>
    <basicUdiDi>B-08809288936801</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>2026-08-07T04:55:14.498Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809288936795</udiDi>
    <basicUdiDi>B-08809288936795</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>2026-08-07T04:55:13.707Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809288936788</udiDi>
    <basicUdiDi>B-08809288936788</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>2026-08-07T04:55:12.903Z</lastUpdated>
  </row>
</eudamedExport>