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    <tradeName>[Barraquer] Eye Speculum, adult</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PSI/EYE-KO, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000022109</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>OPHTHALMIC DEVICES - OTHER</emdnDescription>
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    <reference>8400</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T06:05:06.046Z</lastUpdated>
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    <udiDi>00840516126715</udiDi>
    <basicUdiDi>0840516184006D</basicUdiDi>
    <tradeName>[Barraquer] Eye Speculum, child</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PSI/EYE-KO, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000022109</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>OPHTHALMIC DEVICES - OTHER</emdnDescription>
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    <tradeName>[Kratz] wire speculum, open blades</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PSI/EYE-KO, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000022109</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>OPHTHALMIC DEVICES - OTHER</emdnDescription>
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    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T06:05:06.011Z</lastUpdated>
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    <udiDi>00840516126739</udiDi>
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    <tradeName>Probst Eye Speculum</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PSI/EYE-KO, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000022109</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>OPHTHALMIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8404P</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T06:05:05.989Z</lastUpdated>
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    <udiDi>00840516126746</udiDi>
    <basicUdiDi>0840516184006D</basicUdiDi>
    <tradeName>[Barraquer] Wire Speculum (w/ Tabs)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PSI/EYE-KO, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000022109</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>OPHTHALMIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8405</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T06:05:05.967Z</lastUpdated>
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    <udiDi>00840516129211</udiDi>
    <basicUdiDi>0840516184006D</basicUdiDi>
    <tradeName>[Barraquer] Eye Speculum, adult</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PSI/EYE-KO, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000022109</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>OPHTHALMIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8400</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T06:05:05.945Z</lastUpdated>
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    <udiDi>00840516129228</udiDi>
    <basicUdiDi>0840516184006D</basicUdiDi>
    <tradeName>[Barraquer] Eye Speculum, child</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PSI/EYE-KO, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000022109</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>OPHTHALMIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8401</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T06:05:05.923Z</lastUpdated>
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    <udiDi>00840516129235</udiDi>
    <basicUdiDi>0840516184006D</basicUdiDi>
    <tradeName>[Kratz] wire speculum, open blades</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PSI/EYE-KO, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000022109</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>OPHTHALMIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8404</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T06:05:05.908Z</lastUpdated>
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    <udiDi>00840516129242</udiDi>
    <basicUdiDi>0840516184006D</basicUdiDi>
    <tradeName>Probst Eye Speculum</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PSI/EYE-KO, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000022109</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>OPHTHALMIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8404P</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T06:05:05.893Z</lastUpdated>
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    <udiDi>00840516129259</udiDi>
    <basicUdiDi>0840516184006D</basicUdiDi>
    <tradeName>[Barraquer] Wire Speculum (w/ Tabs)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PSI/EYE-KO, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000022109</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>OPHTHALMIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8405</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T06:05:05.879Z</lastUpdated>
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    <udiDi>00840516138473</udiDi>
    <basicUdiDi>0840516184006D</basicUdiDi>
    <tradeName>[Kratz] Eye Speculum, adult, open blades</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PSI/EYE-KO, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000022109</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>OPHTHALMIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8402</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T06:05:05.854Z</lastUpdated>
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    <udiDi>00840516138503</udiDi>
    <basicUdiDi>0840516184006D</basicUdiDi>
    <tradeName>[Kratz] Eye Speculum, adult, open blades</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PSI/EYE-KO, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000022109</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>OPHTHALMIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8402</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T06:05:05.835Z</lastUpdated>
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    <udiDi>00840516138534</udiDi>
    <basicUdiDi>0840516184006D</basicUdiDi>
    <tradeName>Eye Speculum, adult, solid blades</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PSI/EYE-KO, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000022109</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>OPHTHALMIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8403</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T06:05:05.812Z</lastUpdated>
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    <udiDi>00840516138565</udiDi>
    <basicUdiDi>0840516184006D</basicUdiDi>
    <tradeName>Eye Speculum, adult, solid blades</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PSI/EYE-KO, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000022109</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>OPHTHALMIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8403</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T06:05:05.783Z</lastUpdated>
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    <udiDi>00840516141183</udiDi>
    <basicUdiDi>08405161500054</basicUdiDi>
    <tradeName>Irrigating Cystotome 23G X 19mm, formed 4mm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PSI/EYE-KO, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000022109</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>OCCULAR IRRIGATION AND ASPIRATION CANNULAS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5004BFT</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T06:05:05.756Z</lastUpdated>
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    <udiDi>00840516142838</udiDi>
    <basicUdiDi>08405161500054</basicUdiDi>
    <tradeName>Irrigating Cystotome 23g X 19mm (3/4"), formed</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PSI/EYE-KO, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000022109</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>OCCULAR IRRIGATION AND ASPIRATION CANNULAS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5004BF</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T06:05:05.730Z</lastUpdated>
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    <udiDi>00840516142869</udiDi>
    <basicUdiDi>08405161500054</basicUdiDi>
    <tradeName>Irrigating Cystotome 23g X 19mm (3/4"), formed</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PSI/EYE-KO, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000022109</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>OCCULAR IRRIGATION AND ASPIRATION CANNULAS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5004BF</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T06:05:05.699Z</lastUpdated>
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    <udiDi>00840516143156</udiDi>
    <basicUdiDi>0840516120004F</basicUdiDi>
    <tradeName>Anterior Chamber 27G X 22mm curved, thin wall</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PSI/EYE-KO, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000022109</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>OCCULAR IRRIGATION AND ASPIRATION CANNULAS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2101C</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T06:05:05.677Z</lastUpdated>
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    <udiDi>00840516143187</udiDi>
    <basicUdiDi>0840516120004F</basicUdiDi>
    <tradeName>Anterior Chamber 27G X 22mm curved, thin wall</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PSI/EYE-KO, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000022109</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>OCCULAR IRRIGATION AND ASPIRATION CANNULAS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2101C</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T06:05:05.655Z</lastUpdated>
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    <udiDi>00840516143217</udiDi>
    <basicUdiDi>0840516120004F</basicUdiDi>
    <tradeName>Viscoelastic Cannula 27G, formed, thin wall</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PSI/EYE-KO, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000022109</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>OCCULAR IRRIGATION AND ASPIRATION CANNULAS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2200</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T06:05:05.628Z</lastUpdated>
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