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    <tradeName>Rigi10</tradeName>
    <deviceName>Rigi10™ Malleable Penile Prosthesis</deviceName>
    <manufacturerName>Rigicon, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000027758</manufacturerSrn>
    <authorisedRepresentativeName>Rigicon B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013173</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P080202</emdnCode>
    <emdnDescription>PENILE PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RG1014H</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:09:22.289Z</lastUpdated>
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    <tradeName>Rigi10</tradeName>
    <deviceName>Rigi10™ Malleable Penile Prosthesis</deviceName>
    <manufacturerName>Rigicon, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000027758</manufacturerSrn>
    <authorisedRepresentativeName>Rigicon B.V.</authorisedRepresentativeName>
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    <legislation>MDD</legislation>
    <emdnCode>P080202</emdnCode>
    <emdnDescription>PENILE PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <tradeName>Rigi10</tradeName>
    <deviceName>Rigi10™ Malleable Penile Prosthesis</deviceName>
    <manufacturerName>Rigicon, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000027758</manufacturerSrn>
    <authorisedRepresentativeName>Rigicon B.V.</authorisedRepresentativeName>
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    <emdnDescription>PENILE PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-07-05T08:09:17.484Z</lastUpdated>
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    <tradeName>Rigi10</tradeName>
    <deviceName>Rigi10™ Malleable Penile Prosthesis</deviceName>
    <manufacturerName>Rigicon, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000027758</manufacturerSrn>
    <authorisedRepresentativeName>Rigicon B.V.</authorisedRepresentativeName>
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    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P080202</emdnCode>
    <emdnDescription>PENILE PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RG1011H</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:09:16.687Z</lastUpdated>
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    <udiDi>00850299008450</udiDi>
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    <tradeName>Rigi10</tradeName>
    <deviceName>Rigi10™ Malleable Penile Prosthesis</deviceName>
    <manufacturerName>Rigicon, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000027758</manufacturerSrn>
    <authorisedRepresentativeName>Rigicon B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013173</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P080202</emdnCode>
    <emdnDescription>PENILE PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RG1010H</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:09:15.883Z</lastUpdated>
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    <tradeName>Rigi10</tradeName>
    <deviceName>Rigi10™ Malleable Penile Prosthesis</deviceName>
    <manufacturerName>Rigicon, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000027758</manufacturerSrn>
    <authorisedRepresentativeName>Rigicon B.V.</authorisedRepresentativeName>
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    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P080202</emdnCode>
    <emdnDescription>PENILE PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RG1009H</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:09:11.089Z</lastUpdated>
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    <udiDi>00850299008146</udiDi>
    <basicUdiDi>B-00850299008146</basicUdiDi>
    <tradeName>Testi10™</tradeName>
    <deviceName>Testi10™ Firm Testicular Prosthesis</deviceName>
    <manufacturerName>Rigicon, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000027758</manufacturerSrn>
    <authorisedRepresentativeName>Rigicon B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013173</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P080201</emdnCode>
    <emdnDescription>TESTICLE PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TESTIF-XL</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:09:10.283Z</lastUpdated>
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    <udiDi>00850299008139</udiDi>
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    <tradeName>Testi10™</tradeName>
    <deviceName>Testi10™ Firm Testicular Prosthesis</deviceName>
    <manufacturerName>Rigicon, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000027758</manufacturerSrn>
    <authorisedRepresentativeName>Rigicon B.V.</authorisedRepresentativeName>
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    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P080201</emdnCode>
    <emdnDescription>TESTICLE PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TESTIF-L</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:09:09.481Z</lastUpdated>
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    <udiDi>00850299008122</udiDi>
    <basicUdiDi>B-00850299008122</basicUdiDi>
    <tradeName>Testi10™</tradeName>
    <deviceName>Testi10™ Firm Testicular Prosthesis</deviceName>
    <manufacturerName>Rigicon, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000027758</manufacturerSrn>
    <authorisedRepresentativeName>Rigicon B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013173</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P080201</emdnCode>
    <emdnDescription>TESTICLE PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TESTIF-M</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:09:08.679Z</lastUpdated>
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    <udiDi>00850299008115</udiDi>
    <basicUdiDi>B-00850299008115</basicUdiDi>
    <tradeName>Testi10™</tradeName>
    <deviceName>Testi10™ Firm Testicular Prosthesis</deviceName>
    <manufacturerName>Rigicon, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000027758</manufacturerSrn>
    <authorisedRepresentativeName>Rigicon B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013173</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P080201</emdnCode>
    <emdnDescription>TESTICLE PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TESTIF-S</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:09:04.689Z</lastUpdated>
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    <udiDi>00850299008108</udiDi>
    <basicUdiDi>B-00850299008108</basicUdiDi>
    <tradeName>Testi10™</tradeName>
    <deviceName>Testi10™ Firm Testicular Prosthesis</deviceName>
    <manufacturerName>Rigicon, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000027758</manufacturerSrn>
    <authorisedRepresentativeName>Rigicon B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013173</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P080201</emdnCode>
    <emdnDescription>TESTICLE PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TESTIF-XS</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:09:03.901Z</lastUpdated>
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    <udiDi>00850299008092</udiDi>
    <basicUdiDi>B-00850299008092</basicUdiDi>
    <tradeName>Testi10™</tradeName>
    <deviceName>Testi10™ Saline-Filled Testicular Prosthesis</deviceName>
    <manufacturerName>Rigicon, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000027758</manufacturerSrn>
    <authorisedRepresentativeName>Rigicon B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013173</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P080201</emdnCode>
    <emdnDescription>TESTICLE PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TESTISF-XL</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:09:03.087Z</lastUpdated>
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    <tradeName>Testi10™</tradeName>
    <deviceName>Testi10™ Saline-Filled Testicular Prosthesis</deviceName>
    <manufacturerName>Rigicon, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000027758</manufacturerSrn>
    <authorisedRepresentativeName>Rigicon B.V.</authorisedRepresentativeName>
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    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P080201</emdnCode>
    <emdnDescription>TESTICLE PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TESTISF-L</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:08:59.899Z</lastUpdated>
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    <tradeName>Testi10™</tradeName>
    <deviceName>Testi10™ Saline-Filled Testicular Prosthesis</deviceName>
    <manufacturerName>Rigicon, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000027758</manufacturerSrn>
    <authorisedRepresentativeName>Rigicon B.V.</authorisedRepresentativeName>
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    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P080201</emdnCode>
    <emdnDescription>TESTICLE PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TESTISF-M</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:08:59.083Z</lastUpdated>
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    <tradeName>Testi10™</tradeName>
    <deviceName>Testi10™ Saline-Filled Testicular Prosthesis</deviceName>
    <manufacturerName>Rigicon, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000027758</manufacturerSrn>
    <authorisedRepresentativeName>Rigicon B.V.</authorisedRepresentativeName>
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    <riskClass>Sınıf IIb</riskClass>
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    <emdnDescription>TESTICLE PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TESTISF-XS</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:08:57.599Z</lastUpdated>
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    <basicUdiDi>B-00850033207699</basicUdiDi>
    <tradeName>RigiSoft™</tradeName>
    <deviceName>RigiSoft™ Malleable Penile Prosthesis</deviceName>
    <manufacturerName>Rigicon, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000027758</manufacturerSrn>
    <authorisedRepresentativeName>Rigicon B.V.</authorisedRepresentativeName>
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    <legislation>MDD</legislation>
    <emdnCode>P080202</emdnCode>
    <emdnDescription>PENILE PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RGS1011</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:01:12.766Z</lastUpdated>
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    <tradeName>RigiSoft™</tradeName>
    <deviceName>RigiSoft™ Malleable Penile Prosthesis</deviceName>
    <manufacturerName>Rigicon, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000027758</manufacturerSrn>
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    <emdnDescription>PENILE PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RGS1010</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:01:08.753Z</lastUpdated>
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    <tradeName>RigiSoft™</tradeName>
    <deviceName>RigiSoft™ Malleable Penile Prosthesis</deviceName>
    <manufacturerName>Rigicon, Inc.</manufacturerName>
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    <legislation>MDD</legislation>
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    <emdnDescription>PENILE PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RGS1009</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:01:07.954Z</lastUpdated>
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    <tradeName>RigiSoft™</tradeName>
    <deviceName>RigiSoft™ Malleable Penile Prosthesis</deviceName>
    <manufacturerName>Rigicon, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000027758</manufacturerSrn>
    <authorisedRepresentativeName>Rigicon B.V.</authorisedRepresentativeName>
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    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P080202</emdnCode>
    <emdnDescription>PENILE PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RGS1012</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:01:07.170Z</lastUpdated>
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    <tradeName>RigiSoft™</tradeName>
    <deviceName>RigiSoft™ Malleable Penile Prosthesis</deviceName>
    <manufacturerName>Rigicon, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000027758</manufacturerSrn>
    <authorisedRepresentativeName>Rigicon B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013173</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P080202</emdnCode>
    <emdnDescription>PENILE PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RGS1013</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:01:06.357Z</lastUpdated>
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