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    <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>
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    <reference>CAR-PIBE-40</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-05T22:20:04.309Z</lastUpdated>
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    <tradeName>EZX</tradeName>
    <deviceName>Power Surgical Handpiece System</deviceName>
    <manufacturerName>IMEDICOM Co., Ltd.</manufacturerName>
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    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <reference>H-CAT-010-US-01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-05T22:20:02.705Z</lastUpdated>
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    <basicUdiDi>B-08809317171371</basicUdiDi>
    <tradeName>MEDINAUT-V</tradeName>
    <deviceName>Vertebral Augmentation System</deviceName>
    <manufacturerName>IMEDICOM Co., Ltd.</manufacturerName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>H-CAT-004-US-01</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-05T22:20:01.921Z</lastUpdated>
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    <basicUdiDi>B-08809317171364</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>
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    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
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    <emdnDescription>MINIMALLY INVASIVE SPINAL SURGERY INSTRUMENTS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H-CAT-004-US-01</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-05T22:20:00.305Z</lastUpdated>
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    <udiDi>08809317171357</udiDi>
    <basicUdiDi>B-08809317171357</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>2026-08-05T22:19:57.908Z</lastUpdated>
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    <udiDi>08809317171340</udiDi>
    <basicUdiDi>B-08809317171340</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>2026-08-05T22:19:56.307Z</lastUpdated>
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    <basicUdiDi>B-08809317171333</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>2026-08-05T22:19:55.511Z</lastUpdated>
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    <udiDi>08809317170435</udiDi>
    <basicUdiDi>B-08809317170435</basicUdiDi>
    <tradeName>MEDINUAT, B-Two Vertebral Balloon Expand System</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>H-CAT-004-US-01</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-05T22:19:53.981Z</lastUpdated>
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    <udiDi>08809288930007</udiDi>
    <basicUdiDi>B-08809288930007</basicUdiDi>
    <tradeName>High Speed 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>H-CAT-003-US-01</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-05T22:19:49.897Z</lastUpdated>
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    <udiDi>08800038039643</udiDi>
    <basicUdiDi>B-08800038039643</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>2026-08-05T22:19:49.098Z</lastUpdated>
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    <udiDi>08800038026568</udiDi>
    <basicUdiDi>B-08800038026568</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>
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    <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>2026-08-05T22:19:47.507Z</lastUpdated>
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    <udiDi>08800038026551</udiDi>
    <basicUdiDi>B-08800038026551</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>2026-08-05T22:19:45.099Z</lastUpdated>
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    <basicUdiDi>B-08800038026544</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>2026-08-05T22:19:43.496Z</lastUpdated>
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    <udiDi>08800038044920</udiDi>
    <basicUdiDi>B-08800038044920</basicUdiDi>
    <tradeName>EZX</tradeName>
    <deviceName>Power Surgical handpiece system</deviceName>
    <manufacturerName>IMEDICOM Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000002344</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <emdnDescription>MOTORISED ORTHOPAEDIC SURGERY SYSTEM INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H-CAT-010-US-01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-05T12:09:16.764Z</lastUpdated>
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    <udiDi>08800038032217</udiDi>
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    <tradeName>EZX</tradeName>
    <deviceName>Power Surgical handpiece system</deviceName>
    <manufacturerName>IMEDICOM Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000002344</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <emdnDescription>MOTORISED ORTHOPAEDIC SURGERY SYSTEM INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H-CAT-010-US-01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-05T12:09:12.763Z</lastUpdated>
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    <tradeName>EZX</tradeName>
    <deviceName>Power Surgical handpiece system</deviceName>
    <manufacturerName>IMEDICOM Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000002344</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <emdnDescription>MOTORISED ORTHOPAEDIC SURGERY SYSTEM INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H-CAT-010-US-01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-05T12:09:11.964Z</lastUpdated>
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