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    <tradeName>Rafaelo pack</tradeName>
    <deviceName></deviceName>
    <manufacturerName>F Care Systems</manufacturerName>
    <manufacturerSrn>BE-PR-000000039</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>K01020199</emdnCode>
    <emdnDescription>MINIMALLY INVASIVE SURGERY SURGICAL INSTRUMENT KITS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>06RAFAELOPACK</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T08:04:25.360Z</lastUpdated>
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    <udiDi>05420051302505</udiDi>
    <basicUdiDi>54200513-TF11-NGW-SU-GT</basicUdiDi>
    <tradeName>Sterile Non-Vascular Guidewires</tradeName>
    <deviceName>Sterile Non-Vascular Guidewires</deviceName>
    <manufacturerName>G-FLEX FLEXIBLE INSTRUMENTS EUROPE</manufacturerName>
    <manufacturerSrn>BE-MF-000000623</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>MDR 2017/745</legislation>
    <emdnCode>K01020114</emdnCode>
    <emdnDescription>MINIMALLY INVASIVE SURGERY GUIDES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GW01-35450</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T08:01:48.323Z</lastUpdated>
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    <udiDi>05420051300136</udiDi>
    <basicUdiDi>54200513-TF11-NGW-SU-GT</basicUdiDi>
    <tradeName>Sterile Non-Vascular Guidewires</tradeName>
    <deviceName>Sterile Non-Vascular Guidewires</deviceName>
    <manufacturerName>G-FLEX FLEXIBLE INSTRUMENTS EUROPE</manufacturerName>
    <manufacturerSrn>BE-MF-000000623</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnDescription>MINIMALLY INVASIVE SURGERY GUIDES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>21435400BS</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T07:55:16.213Z</lastUpdated>
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    <udiDi>05060911403654</udiDi>
    <basicUdiDi>506091140SWPG2</basicUdiDi>
    <tradeName>05060911403654</tradeName>
    <deviceName>Sterile Wound Protectors for single use</deviceName>
    <manufacturerName>GENMED ENTERPRISES INTERNATIONAL LTD</manufacturerName>
    <manufacturerSrn>GB-MF-000010687</manufacturerSrn>
    <authorisedRepresentativeName>GENMED ENTERPRISES MEDICAL LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000010419</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>K01020117</emdnCode>
    <emdnDescription>MINIMALLY INVASIVE SURGERY DILATORS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GN-WPF-07</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:57:03.448Z</lastUpdated>
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    <udiDi>05060911401131</udiDi>
    <basicUdiDi>506091140SRBAG6C</basicUdiDi>
    <tradeName>05060911401131</tradeName>
    <deviceName>Sterile Specimen Retrieval Bag for Single Use</deviceName>
    <manufacturerName>GENMED ENTERPRISES INTERNATIONAL LTD</manufacturerName>
    <manufacturerSrn>GB-MF-000010687</manufacturerSrn>
    <authorisedRepresentativeName>GENMED ENTERPRISES MEDICAL LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000010419</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>K01020107</emdnCode>
    <emdnDescription>MINIMALLY INVASIVE SURGERY RECOVERY BAGS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GN-SRB01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:57:01.879Z</lastUpdated>
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    <udiDi>15060557440003</udiDi>
    <basicUdiDi>506055744AAA000R7</basicUdiDi>
    <tradeName>Galaxy II Surgical Retractor</tradeName>
    <deviceName>Galaxy II Snowman Frame</deviceName>
    <manufacturerName>Mosaic Surgical Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000003512</manufacturerSrn>
    <authorisedRepresentativeName>JUNE Medical Sverige AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000001906</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>K01020106</emdnCode>
    <emdnDescription>MINIMALLY INVASIVE SURGERY SPREADERS AND RETRACTORS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>JUNE3000S5</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:48:52.525Z</lastUpdated>
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    <udiDi>05060131887425</udiDi>
    <basicUdiDi>506013188TF093U</basicUdiDi>
    <tradeName>Reliject Pre-Injection Swabs</tradeName>
    <deviceName>Pre-injection Swab</deviceName>
    <manufacturerName>Reliance Medical Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000004799</manufacturerSrn>
    <authorisedRepresentativeName>Reliance Medical (Ireland)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003675</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>K01020109</emdnCode>
    <emdnDescription>MINIMALLY INVASIVE SURGERY SWABS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>742</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:31:43.382Z</lastUpdated>
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    <udiDi>05010058085732</udiDi>
    <basicUdiDi>50100580A22sG002T00AW9</basicUdiDi>
    <tradeName>05010058085732</tradeName>
    <deviceName>ComfiKit Standard IUCD Fitting Pack</deviceName>
    <manufacturerName>Robinson Healthcare Ltd</manufacturerName>
    <manufacturerSrn>GB-PR-000028360</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>K01020120</emdnCode>
    <emdnDescription>MINIMALLY INVASIVE SURGERY SURGICAL INSTRUMENT KITS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8573</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:45:44.968Z</lastUpdated>
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    <udiDi>04897054300837</udiDi>
    <basicUdiDi>489705430REVEELQC</basicUdiDi>
    <tradeName>04897054300837</tradeName>
    <deviceName>REVEEL Endoscopic Retractor</deviceName>
    <manufacturerName>RETRACTION LIMITED</manufacturerName>
    <manufacturerSrn>HK-MF-000038989</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>K01020106</emdnCode>
    <emdnDescription>MINIMALLY INVASIVE SURGERY SPREADERS AND RETRACTORS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RT083001</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:13:29.181Z</lastUpdated>
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    <udiDi>04714123029317</udiDi>
    <basicUdiDi>471412302MG-01SW</basicUdiDi>
    <tradeName>Mini Laparoscopy Grasping Device</tradeName>
    <deviceName>Mini Laparoscopy Grasping Device</deviceName>
    <manufacturerName>Lagis Enterprise Co., Ltd.</manufacturerName>
    <manufacturerSrn>TW-MF-000007081</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>K01020104</emdnCode>
    <emdnDescription>MINIMALLY INVASIVE SURGERY FORCEPS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MG-10512N</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:41:55.750Z</lastUpdated>
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    <udiDi>04714123024107</udiDi>
    <basicUdiDi>471412302SA-01TN</basicUdiDi>
    <tradeName>Suction Irrigation System</tradeName>
    <deviceName>Suction Irrigation System</deviceName>
    <manufacturerName>Lagis Enterprise Co., Ltd.</manufacturerName>
    <manufacturerSrn>TW-MF-000007081</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>K01020110</emdnCode>
    <emdnDescription>MINIMALLY INVASIVE SURGERY CANNULAS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SA-520CT</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:41:49.342Z</lastUpdated>
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    <udiDi>04714123023391</udiDi>
    <basicUdiDi>471412302LB-01RG</basicUdiDi>
    <tradeName>Laparoscopic Kit</tradeName>
    <deviceName>Laparoscopic Kit-LB Kit</deviceName>
    <manufacturerName>Lagis Enterprise Co., Ltd.</manufacturerName>
    <manufacturerSrn>TW-PR-000026825</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>K01020120</emdnCode>
    <emdnDescription>MINIMALLY INVASIVE SURGERY SURGICAL INSTRUMENT KITS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LB-1101</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:41:48.530Z</lastUpdated>
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    <udiDi>04714123022240</udiDi>
    <basicUdiDi>471412302WR-01YR</basicUdiDi>
    <tradeName>Wound Retractor</tradeName>
    <deviceName>Wound Retractor</deviceName>
    <manufacturerName>Lagis Enterprise Co., Ltd.</manufacturerName>
    <manufacturerSrn>TW-MF-000007081</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>K01020106</emdnCode>
    <emdnDescription>MINIMALLY INVASIVE SURGERY SPREADERS AND RETRACTORS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WR-80S</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:41:43.726Z</lastUpdated>
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    <udiDi>04714123022059</udiDi>
    <basicUdiDi>471412302LC-01RP</basicUdiDi>
    <tradeName>Laparoscopic Kit</tradeName>
    <deviceName>Laparoscopic kit</deviceName>
    <manufacturerName>Lagis Enterprise Co., Ltd.</manufacturerName>
    <manufacturerSrn>TW-PR-000026825</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>K01020120</emdnCode>
    <emdnDescription>MINIMALLY INVASIVE SURGERY SURGICAL INSTRUMENT KITS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LC-0002</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:41:42.150Z</lastUpdated>
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    <udiDi>04714123029447</udiDi>
    <basicUdiDi>471412302EBS-01PX</basicUdiDi>
    <tradeName>Tissue containment bag</tradeName>
    <deviceName>Tissue Containment Bag</deviceName>
    <manufacturerName>Lagis Enterprise Co., Ltd.</manufacturerName>
    <manufacturerSrn>TW-MF-000007081</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>K01020107</emdnCode>
    <emdnDescription>MINIMALLY INVASIVE SURGERY RECOVERY BAGS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBS-0810</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:32:59.251Z</lastUpdated>
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    <udiDi>04714123029300</udiDi>
    <basicUdiDi>471412302MG-01SW</basicUdiDi>
    <tradeName>Mini Laparoscopy Grasping Device</tradeName>
    <deviceName>Mini Laparoscopy Grasping Device</deviceName>
    <manufacturerName>Lagis Enterprise Co., Ltd.</manufacturerName>
    <manufacturerSrn>TW-MF-000007081</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>K01020104</emdnCode>
    <emdnDescription>MINIMALLY INVASIVE SURGERY FORCEPS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MG-1801</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:32:55.277Z</lastUpdated>
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    <udiDi>04714123024091</udiDi>
    <basicUdiDi>471412302SA-01TN</basicUdiDi>
    <tradeName>Suction Irrigation System</tradeName>
    <deviceName>Suction Irrigation System</deviceName>
    <manufacturerName>Lagis Enterprise Co., Ltd.</manufacturerName>
    <manufacturerSrn>TW-MF-000007081</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>K01020110</emdnCode>
    <emdnDescription>MINIMALLY INVASIVE SURGERY CANNULAS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SA-520C</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:32:52.849Z</lastUpdated>
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    <udiDi>04714123023384</udiDi>
    <basicUdiDi>471412302LB-01RG</basicUdiDi>
    <tradeName>Laparoscopic Kit</tradeName>
    <deviceName>Laparoscopic Kit-LB Kit</deviceName>
    <manufacturerName>Lagis Enterprise Co., Ltd.</manufacturerName>
    <manufacturerSrn>TW-PR-000026825</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
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    <emdnCode>K01020120</emdnCode>
    <emdnDescription>MINIMALLY INVASIVE SURGERY SURGICAL INSTRUMENT KITS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LB-1100</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:32:48.021Z</lastUpdated>
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    <udiDi>04714123022172</udiDi>
    <basicUdiDi>471412302WR-01YR</basicUdiDi>
    <tradeName>Wound Retractor</tradeName>
    <deviceName>Wound Retractor</deviceName>
    <manufacturerName>Lagis Enterprise Co., Ltd.</manufacturerName>
    <manufacturerSrn>TW-MF-000007081</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>K01020106</emdnCode>
    <emdnDescription>MINIMALLY INVASIVE SURGERY SPREADERS AND RETRACTORS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WR-60ES</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:32:45.630Z</lastUpdated>
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    <udiDi>04714123022042</udiDi>
    <basicUdiDi>471412302LC-01RP</basicUdiDi>
    <tradeName>Laparoscopic Kit</tradeName>
    <deviceName>Laparoscopic kit</deviceName>
    <manufacturerName>Lagis Enterprise Co., Ltd.</manufacturerName>
    <manufacturerSrn>TW-PR-000026825</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>K01020120</emdnCode>
    <emdnDescription>MINIMALLY INVASIVE SURGERY SURGICAL INSTRUMENT KITS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LC-0001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:32:40.834Z</lastUpdated>
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