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    <tradeName>VACS III 10.0 x 30</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OSYPKA GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005610</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C019014</emdnCode>
    <emdnDescription>CARDIAC VALVULOPLASTY CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>YA31030</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T11:51:49.996Z</lastUpdated>
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    <udiDi>18904224928418</udiDi>
    <basicUdiDi>B-18904224928418</basicUdiDi>
    <tradeName>Mammoth Neo™</tradeName>
    <deviceName>Mammoth Neo™ Balloon Dilatation Catheter</deviceName>
    <manufacturerName>Meril Life Sciences Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000008308</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C019014</emdnCode>
    <emdnDescription>CARDIAC VALVULOPLASTY CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MTVN3040</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-11T08:54:14.982Z</lastUpdated>
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    <udiDi>18904224928401</udiDi>
    <basicUdiDi>B-18904224928401</basicUdiDi>
    <tradeName>Mammoth Neo™</tradeName>
    <deviceName>Mammoth Neo™ Balloon Dilatation Catheter</deviceName>
    <manufacturerName>Meril Life Sciences Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000008308</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C019014</emdnCode>
    <emdnDescription>CARDIAC VALVULOPLASTY CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MTVN2840</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-11T08:54:11.002Z</lastUpdated>
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    <udiDi>18904224928388</udiDi>
    <basicUdiDi>B-18904224928388</basicUdiDi>
    <tradeName>Mammoth Neo™</tradeName>
    <deviceName>Mammoth Neo™ Balloon Dilatation Catheter</deviceName>
    <manufacturerName>Meril Life Sciences Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000008308</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C019014</emdnCode>
    <emdnDescription>CARDIAC VALVULOPLASTY CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MTVN2340</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-11T08:54:10.186Z</lastUpdated>
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    <udiDi>18904224928371</udiDi>
    <basicUdiDi>B-18904224928371</basicUdiDi>
    <tradeName>Mammoth Neo™</tradeName>
    <deviceName>Mammoth Neo™ Balloon Dilatation Catheter</deviceName>
    <manufacturerName>Meril Life Sciences Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000008308</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C019014</emdnCode>
    <emdnDescription>CARDIAC VALVULOPLASTY CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MTVN2040</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-11T08:54:09.382Z</lastUpdated>
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    <udiDi>18904224928364</udiDi>
    <basicUdiDi>B-18904224928364</basicUdiDi>
    <tradeName>Mammoth Neo™</tradeName>
    <deviceName>Mammoth Neo™ Balloon Dilatation Catheter</deviceName>
    <manufacturerName>Meril Life Sciences Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000008308</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C019014</emdnCode>
    <emdnDescription>CARDIAC VALVULOPLASTY CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MTVN1840</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-11T08:54:08.605Z</lastUpdated>
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    <udiDi>18904224928357</udiDi>
    <basicUdiDi>B-18904224928357</basicUdiDi>
    <tradeName>Mammoth Neo™</tradeName>
    <deviceName>Mammoth Neo™ Balloon Dilatation Catheter</deviceName>
    <manufacturerName>Meril Life Sciences Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000008308</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C019014</emdnCode>
    <emdnDescription>CARDIAC VALVULOPLASTY CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MTVN1640</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-11T08:54:04.596Z</lastUpdated>
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    <udiDi>18904224928340</udiDi>
    <basicUdiDi>B-18904224928340</basicUdiDi>
    <tradeName>Mammoth Neo™</tradeName>
    <deviceName>Mammoth Neo™ Balloon Dilatation Catheter</deviceName>
    <manufacturerName>Meril Life Sciences Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000008308</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C019014</emdnCode>
    <emdnDescription>CARDIAC VALVULOPLASTY CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MTVN1440</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-11T08:54:03.779Z</lastUpdated>
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    <udiDi>18904224928333</udiDi>
    <basicUdiDi>B-18904224928333</basicUdiDi>
    <tradeName>Mammoth™</tradeName>
    <deviceName>Mammoth™ Balloon Dilatation Catheter</deviceName>
    <manufacturerName>Meril Life Sciences Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000008308</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C019014</emdnCode>
    <emdnDescription>CARDIAC VALVULOPLASTY CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MTV3040</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-11T08:54:02.990Z</lastUpdated>
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    <udiDi>18904224928326</udiDi>
    <basicUdiDi>B-18904224928326</basicUdiDi>
    <tradeName>Mammoth ™</tradeName>
    <deviceName>Mammoth ™ Balloon Dilatation Catheter</deviceName>
    <manufacturerName>Meril Life Sciences Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000008308</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C019014</emdnCode>
    <emdnDescription>CARDIAC VALVULOPLASTY CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MTV1440</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-11T08:54:02.189Z</lastUpdated>
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    <udiDi>18904224927206</udiDi>
    <basicUdiDi>B-18904224927206</basicUdiDi>
    <tradeName>Mammoth™</tradeName>
    <deviceName>Mammoth™ Balloon Dilatation Catheter</deviceName>
    <manufacturerName>Meril Life Sciences Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000008308</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C019014</emdnCode>
    <emdnDescription>CARDIAC VALVULOPLASTY CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MTV2840</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-11T08:50:56.314Z</lastUpdated>
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    <udiDi>18904224926162</udiDi>
    <basicUdiDi>B-18904224926162</basicUdiDi>
    <tradeName>Mammoth™</tradeName>
    <deviceName>Mammoth™ Balloon Dilatation Catheter</deviceName>
    <manufacturerName>Meril Life Sciences Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000008308</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C019014</emdnCode>
    <emdnDescription>CARDIAC VALVULOPLASTY CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MTV2540</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-11T08:50:18.656Z</lastUpdated>
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    <udiDi>18904224926148</udiDi>
    <basicUdiDi>B-18904224926148</basicUdiDi>
    <tradeName>Mammoth™</tradeName>
    <deviceName>Mammoth™ Balloon Dilatation Catheter</deviceName>
    <manufacturerName>Meril Life Sciences Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000008308</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C019014</emdnCode>
    <emdnDescription>CARDIAC VALVULOPLASTY CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MTV2040</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-11T08:50:13.837Z</lastUpdated>
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    <udiDi>10887714033244</udiDi>
    <basicUdiDi>B-10887714033244</basicUdiDi>
    <tradeName>NuCLEUS</tradeName>
    <deviceName>NuCLEUS</deviceName>
    <manufacturerName>NuMED, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010948</manufacturerSrn>
    <authorisedRepresentativeName>EVOMED S.L.U.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000047116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C019014</emdnCode>
    <emdnDescription>CARDIAC VALVULOPLASTY CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PVN255</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:33:59.373Z</lastUpdated>
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    <udiDi>10887714033237</udiDi>
    <basicUdiDi>B-10887714033237</basicUdiDi>
    <tradeName>NuCLEUS</tradeName>
    <deviceName>NuCLEUS</deviceName>
    <manufacturerName>NuMED, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010948</manufacturerSrn>
    <authorisedRepresentativeName>EVOMED S.L.U.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000047116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C019014</emdnCode>
    <emdnDescription>CARDIAC VALVULOPLASTY CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PVN254</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:33:55.407Z</lastUpdated>
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    <udiDi>10887714033220</udiDi>
    <basicUdiDi>B-10887714033220</basicUdiDi>
    <tradeName>NuCLEUS</tradeName>
    <deviceName>NuCLEUS</deviceName>
    <manufacturerName>NuMED, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010948</manufacturerSrn>
    <authorisedRepresentativeName>EVOMED S.L.U.</authorisedRepresentativeName>
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    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C019014</emdnCode>
    <emdnDescription>CARDIAC VALVULOPLASTY CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PVN253</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:33:54.582Z</lastUpdated>
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    <udiDi>10887714033213</udiDi>
    <basicUdiDi>B-10887714033213</basicUdiDi>
    <tradeName>NuCLEUS</tradeName>
    <deviceName>NuCLEUS</deviceName>
    <manufacturerName>NuMED, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010948</manufacturerSrn>
    <authorisedRepresentativeName>EVOMED S.L.U.</authorisedRepresentativeName>
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    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C019014</emdnCode>
    <emdnDescription>CARDIAC VALVULOPLASTY CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PVN252</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:33:53.778Z</lastUpdated>
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    <basicUdiDi>B-10887714033206</basicUdiDi>
    <tradeName>NuCLEUS</tradeName>
    <deviceName>NuCLEUS</deviceName>
    <manufacturerName>NuMED, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010948</manufacturerSrn>
    <authorisedRepresentativeName>EVOMED S.L.U.</authorisedRepresentativeName>
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    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C019014</emdnCode>
    <emdnDescription>CARDIAC VALVULOPLASTY CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PVN251</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:33:52.969Z</lastUpdated>
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    <basicUdiDi>B-10887714033176</basicUdiDi>
    <tradeName>NuCLEUS</tradeName>
    <deviceName>NuCLEUS</deviceName>
    <manufacturerName>NuMED, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010948</manufacturerSrn>
    <authorisedRepresentativeName>EVOMED S.L.U.</authorisedRepresentativeName>
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    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C019014</emdnCode>
    <emdnDescription>CARDIAC VALVULOPLASTY CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PVN248</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:33:48.963Z</lastUpdated>
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    <basicUdiDi>B-10887714033169</basicUdiDi>
    <tradeName>NuCLEUS</tradeName>
    <deviceName>NuCLEUS</deviceName>
    <manufacturerName>NuMED, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010948</manufacturerSrn>
    <authorisedRepresentativeName>EVOMED S.L.U.</authorisedRepresentativeName>
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    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C019014</emdnCode>
    <emdnDescription>CARDIAC VALVULOPLASTY CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PVN247</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:33:48.166Z</lastUpdated>
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