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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>
    <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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    <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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    <udiDi>00850299008085</udiDi>
    <basicUdiDi>B-00850299008085</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-L</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:08:59.899Z</lastUpdated>
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    <udiDi>00850299008078</udiDi>
    <basicUdiDi>B-00850299008078</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-M</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:08:59.083Z</lastUpdated>
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    <udiDi>00850299008054</udiDi>
    <basicUdiDi>B-00850299008054</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-XS</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:08:57.599Z</lastUpdated>
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    <udiDi>00850033207699</udiDi>
    <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>
    <authorisedRepresentativeSrn>NL-AR-000013173</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <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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    <udiDi>00850033207682</udiDi>
    <basicUdiDi>B-00850033207682</basicUdiDi>
    <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>RGS1010</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:01:08.753Z</lastUpdated>
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    <udiDi>00850033207675</udiDi>
    <basicUdiDi>B-00850033207675</basicUdiDi>
    <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>RGS1009</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:01:07.954Z</lastUpdated>
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    <udiDi>00850033207644</udiDi>
    <basicUdiDi>B-00850033207644</basicUdiDi>
    <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>RGS1012</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:01:07.170Z</lastUpdated>
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    <udiDi>00850033207637</udiDi>
    <basicUdiDi>B-00850033207637</basicUdiDi>
    <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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    <udiDi>00850033207620</udiDi>
    <basicUdiDi>B-00850033207620</basicUdiDi>
    <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>RGS1014</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:01:02.357Z</lastUpdated>
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    <udiDi>00850015358791</udiDi>
    <basicUdiDi>B-00850015358791</basicUdiDi>
    <tradeName>Testi10™</tradeName>
    <deviceName>Testi10™ Saline 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>TESTIS-XL</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:00:18.246Z</lastUpdated>
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    <udiDi>00850015358784</udiDi>
    <basicUdiDi>B-00850015358784</basicUdiDi>
    <tradeName>Testi10™</tradeName>
    <deviceName>Testi10™ Saline 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>TESTIS-L</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:00:14.242Z</lastUpdated>
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    <udiDi>00850015358760</udiDi>
    <basicUdiDi>B-00850015358760</basicUdiDi>
    <tradeName>Testi10™</tradeName>
    <deviceName>Testi10™ Saline 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>TESTIS-M</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:00:13.445Z</lastUpdated>
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    <udiDi>00850015358753</udiDi>
    <basicUdiDi>B-00850015358753</basicUdiDi>
    <tradeName>Testi10™</tradeName>
    <deviceName>Testi10™ Saline 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>TESTIS-XS</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:00:12.640Z</lastUpdated>
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    <udiDi>00850004725047</udiDi>
    <basicUdiDi>B-00850004725047</basicUdiDi>
    <tradeName>Deflux Gel for Injection</tradeName>
    <deviceName>DEFLUX SYRINGE (1ML)</deviceName>
    <manufacturerName>Palette Life Sciences Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000014009</manufacturerSrn>
    <authorisedRepresentativeName>Scandinavian Regulatory Services AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000004526</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P080302</emdnCode>
    <emdnDescription>URETERAL PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>011503</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:51:23.133Z</lastUpdated>
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    <udiDi>00606401109030</udiDi>
    <basicUdiDi>B-00606401109030</basicUdiDi>
    <tradeName>Nagor Limited</tradeName>
    <deviceName>TFI LSR Filled Testicular Implant</deviceName>
    <manufacturerName>Nagor Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000019179</manufacturerSrn>
    <authorisedRepresentativeName>GC Aesthetics (Management) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000004118</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P080201</emdnCode>
    <emdnDescription>TESTICLE PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TFI-3</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T13:51:06.021Z</lastUpdated>
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    <udiDi>00606401109023</udiDi>
    <basicUdiDi>B-00606401109023</basicUdiDi>
    <tradeName>Nagor Limited</tradeName>
    <deviceName>TFI LSR Filled Testicular Implant</deviceName>
    <manufacturerName>Nagor Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000019179</manufacturerSrn>
    <authorisedRepresentativeName>GC Aesthetics (Management) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000004118</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P080201</emdnCode>
    <emdnDescription>TESTICLE PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TFI-2</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T13:51:05.226Z</lastUpdated>
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</eudamedExport>