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    <tradeName>06950203335857</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Innovex Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000015981</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U0601</emdnCode>
    <emdnDescription>UROLOGICAL GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IVX-UG-3515USR</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-09T08:28:16.196Z</lastUpdated>
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    <udiDi>06950203336199</udiDi>
    <basicUdiDi>69502033UGUZG</basicUdiDi>
    <tradeName>06950203336199</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Innovex Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000015981</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U0601</emdnCode>
    <emdnDescription>UROLOGICAL GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IVX-UG-3815USO</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-09T08:28:16.157Z</lastUpdated>
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    <udiDi>06950203336410</udiDi>
    <basicUdiDi>69502033UGNZ2</basicUdiDi>
    <tradeName>06950203336410</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Innovex Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000015981</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U0601</emdnCode>
    <emdnDescription>UROLOGICAL GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IVX-UG-3815NSO</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-09T08:28:16.133Z</lastUpdated>
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    <udiDi>06972263489486</udiDi>
    <basicUdiDi>B-06972263489486</basicUdiDi>
    <tradeName>Disposable Nonvascular Guide Wires</tradeName>
    <deviceName>Disposable Nonvascular Guide Wires</deviceName>
    <manufacturerName>Jiangxi ZhuoRuiHua Medical Instrument Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027760</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U0601</emdnCode>
    <emdnDescription>UROLOGICAL GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B-06972263489486</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-06T11:48:03.876Z</lastUpdated>
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    <udiDi>06972263488212</udiDi>
    <basicUdiDi>B-06972263488212</basicUdiDi>
    <tradeName>Disposable Nonvascular Guide Wires</tradeName>
    <deviceName>Disposable Nonvascular Guide Wires</deviceName>
    <manufacturerName>Jiangxi ZhuoRuiHua Medical Instrument Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027760</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U0601</emdnCode>
    <emdnDescription>UROLOGICAL GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B-06972263488212</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T11:48:02.084Z</lastUpdated>
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    <udiDi>06925922187025</udiDi>
    <basicUdiDi>B-06925922187025</basicUdiDi>
    <tradeName>06925922187025</tradeName>
    <deviceName>Guide Wires</deviceName>
    <manufacturerName>Xiamen New Concept Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037546</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U0601</emdnCode>
    <emdnDescription>UROLOGICAL GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3123090106</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T07:19:47.490Z</lastUpdated>
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    <udiDi>06925922187018</udiDi>
    <basicUdiDi>B-06925922187018</basicUdiDi>
    <tradeName>06925922187018</tradeName>
    <deviceName>Guide Wires</deviceName>
    <manufacturerName>Xiamen New Concept Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037546</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U0601</emdnCode>
    <emdnDescription>UROLOGICAL GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3123080106</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T07:19:32.231Z</lastUpdated>
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    <udiDi>06925922186950</udiDi>
    <basicUdiDi>B-06925922186950</basicUdiDi>
    <tradeName>06925922186950</tradeName>
    <deviceName>Guide Wires</deviceName>
    <manufacturerName>Xiamen New Concept Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037546</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U0601</emdnCode>
    <emdnDescription>UROLOGICAL GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3123040103</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T07:19:31.438Z</lastUpdated>
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    <udiDi>06925922186943</udiDi>
    <basicUdiDi>B-06925922186943</basicUdiDi>
    <tradeName>06925922186943</tradeName>
    <deviceName>Guide Wires</deviceName>
    <manufacturerName>Xiamen New Concept Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037546</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U0601</emdnCode>
    <emdnDescription>UROLOGICAL GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3123030403</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T07:19:27.430Z</lastUpdated>
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    <udiDi>06925922186936</udiDi>
    <basicUdiDi>B-06925922186936</basicUdiDi>
    <tradeName>06925922186936</tradeName>
    <deviceName>Guide Wires</deviceName>
    <manufacturerName>Xiamen New Concept Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037546</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U0601</emdnCode>
    <emdnDescription>UROLOGICAL GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3123020103</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T07:19:26.640Z</lastUpdated>
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    <udiDi>06925922186882</udiDi>
    <basicUdiDi>B-06925922186882</basicUdiDi>
    <tradeName>06925922186882</tradeName>
    <deviceName>Guide Wires</deviceName>
    <manufacturerName>Xiamen New Concept Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037546</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U0601</emdnCode>
    <emdnDescription>UROLOGICAL GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3122040103</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T07:19:25.827Z</lastUpdated>
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    <udiDi>06925922186875</udiDi>
    <basicUdiDi>B-06925922186875</basicUdiDi>
    <tradeName>06925922186875</tradeName>
    <deviceName>Guide Wires</deviceName>
    <manufacturerName>Xiamen New Concept Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037546</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U0601</emdnCode>
    <emdnDescription>UROLOGICAL GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3122030103</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T07:19:25.039Z</lastUpdated>
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    <udiDi>06925922186868</udiDi>
    <basicUdiDi>B-06925922186868</basicUdiDi>
    <tradeName>06925922186868</tradeName>
    <deviceName>Guide Wires</deviceName>
    <manufacturerName>Xiamen New Concept Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037546</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U0601</emdnCode>
    <emdnDescription>UROLOGICAL GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3122020103</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T07:19:21.031Z</lastUpdated>
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  <row>
    <udiDi>00816840020364</udiDi>
    <basicUdiDi>B-00816840020364</basicUdiDi>
    <tradeName>Bard™ Solo Flex Urology Wire (.038 NiTi, Angled)</tradeName>
    <deviceName>Bard™ Solo Flex Urology Wire (.038 NiTi, Angled)</deviceName>
    <manufacturerName>Heraeus Medical Components LLC</manufacturerName>
    <manufacturerSrn>US-MF-000018306</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U0601</emdnCode>
    <emdnDescription>UROLOGICAL GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HW38FA</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:43:12.905Z</lastUpdated>
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    <udiDi>00816840020357</udiDi>
    <basicUdiDi>B-00816840020357</basicUdiDi>
    <tradeName>Bard™ Solo Flex Urology Wire (.035 NiTi, Angled)</tradeName>
    <deviceName>Bard™ Solo Flex Urology Wire (.035 NiTi, Angled)</deviceName>
    <manufacturerName>Heraeus Medical Components LLC</manufacturerName>
    <manufacturerSrn>US-MF-000018306</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U0601</emdnCode>
    <emdnDescription>UROLOGICAL GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HW35FA</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:43:10.515Z</lastUpdated>
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  <row>
    <udiDi>00816840020340</udiDi>
    <basicUdiDi>B-00816840020340</basicUdiDi>
    <tradeName>Bard™ Solo Flex Urology Wire (.038 NiTi, Straight)</tradeName>
    <deviceName>Bard™ Solo Flex Urology Wire (.038 NiTi, Straight)</deviceName>
    <manufacturerName>Heraeus Medical Components LLC</manufacturerName>
    <manufacturerSrn>US-MF-000018306</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U0601</emdnCode>
    <emdnDescription>UROLOGICAL GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HW38FS</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:43:08.901Z</lastUpdated>
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    <udiDi>00816840020333</udiDi>
    <basicUdiDi>B-00816840020333</basicUdiDi>
    <tradeName>Bard™ Solo Flex Urology Wire (.035 NiTi, Straight)</tradeName>
    <deviceName>Bard™ Solo Flex Urology Wire (.035 NiTi, Straight)</deviceName>
    <manufacturerName>Heraeus Medical Components LLC</manufacturerName>
    <manufacturerSrn>US-MF-000018306</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U0601</emdnCode>
    <emdnDescription>UROLOGICAL GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HW35FS</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:43:08.112Z</lastUpdated>
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  <row>
    <udiDi>00816840020326</udiDi>
    <basicUdiDi>B-00816840020326</basicUdiDi>
    <tradeName>Bard™ Solo Plus Urology Wire (.038 Triton, Angled)</tradeName>
    <deviceName>Bard™ Solo Plus Urology Wire (.038 Triton, Angled)</deviceName>
    <manufacturerName>Heraeus Medical Components LLC</manufacturerName>
    <manufacturerSrn>US-MF-000018306</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U0601</emdnCode>
    <emdnDescription>UROLOGICAL GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HW38SA</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:43:06.498Z</lastUpdated>
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    <udiDi>00816840020319</udiDi>
    <basicUdiDi>B-00816840020319</basicUdiDi>
    <tradeName>Bard™ Solo Plus Urology Wire (.035 Triton, Angled)</tradeName>
    <deviceName>Bard™ Solo Plus Urology Wire (.035 Triton, Angled)</deviceName>
    <manufacturerName>Heraeus Medical Components LLC</manufacturerName>
    <manufacturerSrn>US-MF-000018306</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U0601</emdnCode>
    <emdnDescription>UROLOGICAL GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HW35SA</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:43:04.108Z</lastUpdated>
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  <row>
    <udiDi>00816840020302</udiDi>
    <basicUdiDi>B-00816840020302</basicUdiDi>
    <tradeName>Bard™ Solo Plus Urology Wire (.038 Triton, Straight)</tradeName>
    <deviceName>Bard™ Solo Plus Urology Wire (.038 Triton, Straight)</deviceName>
    <manufacturerName>Heraeus Medical Components LLC</manufacturerName>
    <manufacturerSrn>US-MF-000018306</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U0601</emdnCode>
    <emdnDescription>UROLOGICAL GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HW38SS</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:43:02.512Z</lastUpdated>
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