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    <tradeName>PATIENT CHAIR</tradeName>
    <deviceName>CATALYS PATIENT CHAIR</deviceName>
    <manufacturerName>AMO Manufacturing USA, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000023322</manufacturerSrn>
    <authorisedRepresentativeName>AMO Ireland</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000013513</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12120280</emdnCode>
    <emdnDescription>THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0160-6030</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:58:38.912Z</lastUpdated>
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    <udiDi>04049539069146</udiDi>
    <basicUdiDi>4049539_1_6914_UZ</basicUdiDi>
    <tradeName>EDIS</tradeName>
    <deviceName>EDIS</deviceName>
    <manufacturerName>Carl Zeiss Meditec AG</manufacturerName>
    <manufacturerSrn>DE-MF-000007732</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12120280</emdnCode>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>6914</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:46:35.058Z</lastUpdated>
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    <udiDi>00813125010164</udiDi>
    <basicUdiDi>081312501ESF8P</basicUdiDi>
    <tradeName>Eye Safety Filter, Fixed (810 nm)</tradeName>
    <deviceName>Eye Safety Filter (ESF)</deviceName>
    <manufacturerName>Iridex Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000029814</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12120280</emdnCode>
    <emdnDescription>THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11326</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:16:45.717Z</lastUpdated>
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    <udiDi>00380657529872</udiDi>
    <basicUdiDi>038065GMN000075HA</basicUdiDi>
    <tradeName>PUREPOINT</tradeName>
    <deviceName>PurePoint Laser Indirect Ophthalmoscope</deviceName>
    <manufacturerName>Alcon Laboratories, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016248</manufacturerSrn>
    <authorisedRepresentativeName>Alcon Laboratories Belgium</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000014721</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12120280</emdnCode>
    <emdnDescription>THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8065752987</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:23:25.824Z</lastUpdated>
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  <row>
    <udiDi>00380657511952</udiDi>
    <basicUdiDi>038065GMN000077HE</basicUdiDi>
    <tradeName>00380657511952</tradeName>
    <deviceName>Adaptation</deviceName>
    <manufacturerName>Alcon Laboratories, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016248</manufacturerSrn>
    <authorisedRepresentativeName>Alcon Laboratories Belgium</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000014721</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12120280</emdnCode>
    <emdnDescription>THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8065751195</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:23:02.878Z</lastUpdated>
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  <row>
    <udiDi>+B749300003030</udiDi>
    <basicUdiDi>++B749002KJ</basicUdiDi>
    <tradeName>Valeda LumiKey</tradeName>
    <deviceName>Valeda LumiKey</deviceName>
    <manufacturerName>LumiThera, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000029866</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12120280</emdnCode>
    <emdnDescription>THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>300003</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:56:50.879Z</lastUpdated>
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    <udiDi>05055272721431</udiDi>
    <basicUdiDi>B-05055272721431</basicUdiDi>
    <tradeName>ERBE ERBOKRYO SINGLE USE PROBE ADAPTOR</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Keeler Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000009031</manufacturerSrn>
    <authorisedRepresentativeName>Keeler Europe Distribution, S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001559</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12120280</emdnCode>
    <emdnDescription>THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2509-P-8037</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-19T04:18:19.779Z</lastUpdated>
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  <row>
    <udiDi>05055272721424</udiDi>
    <basicUdiDi>B-05055272721424</basicUdiDi>
    <tradeName>DORC CRYOSTAR SINGLE USE PROBE ADAPTOR</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Keeler Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000009031</manufacturerSrn>
    <authorisedRepresentativeName>Keeler Europe Distribution, S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001559</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12120280</emdnCode>
    <emdnDescription>THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2509-P-8036</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-19T04:18:18.912Z</lastUpdated>
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  <row>
    <udiDi>00813125010188</udiDi>
    <basicUdiDi>081312501ESF8P</basicUdiDi>
    <tradeName>Eye Safety Filter, Fixed (810 nm)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Iridex Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000029814</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12120280</emdnCode>
    <emdnDescription>THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>13107</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T20:38:30.350Z</lastUpdated>
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  <row>
    <udiDi>00813125010195</udiDi>
    <basicUdiDi>081312501ESF8P</basicUdiDi>
    <tradeName>Eye Safety Filter, Fixed (810 nm)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Iridex Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000029814</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12120280</emdnCode>
    <emdnDescription>THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>14080</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T20:38:30.331Z</lastUpdated>
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  <row>
    <udiDi>00813125010201</udiDi>
    <basicUdiDi>081312501ESF8P</basicUdiDi>
    <tradeName>Eye Safety Filter, Fixed (532 nm)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Iridex Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000029814</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12120280</emdnCode>
    <emdnDescription>THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30365</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T20:38:30.318Z</lastUpdated>
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  <row>
    <udiDi>00813125010249</udiDi>
    <basicUdiDi>081312501ESF8P</basicUdiDi>
    <tradeName>Eye Safety Filter, Fixed (532 nm)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Iridex Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000029814</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12120280</emdnCode>
    <emdnDescription>THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30775</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T20:38:30.305Z</lastUpdated>
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    <udiDi>00813125010256</udiDi>
    <basicUdiDi>081312501ESF8P</basicUdiDi>
    <tradeName>Eye Safety Filter, Fixed (532 nm)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Iridex Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000029814</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <emdnCode>Z12120280</emdnCode>
    <emdnDescription>THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>31260</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T20:38:30.288Z</lastUpdated>
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    <udiDi>00813125010263</udiDi>
    <basicUdiDi>081312501ESF8P</basicUdiDi>
    <tradeName>Eye Safety Two-Position (532 nm)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Iridex Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000029814</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <emdnCode>Z12120280</emdnCode>
    <emdnDescription>THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30494</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T20:38:30.273Z</lastUpdated>
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    <udiDi>00813125010270</udiDi>
    <basicUdiDi>081312501ESF8P</basicUdiDi>
    <tradeName>Eye Safety Two-Position (532 nm)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Iridex Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000029814</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <emdnDescription>THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30493</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T20:38:30.257Z</lastUpdated>
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    <udiDi>00813125014490</udiDi>
    <basicUdiDi>081312501ESF8P</basicUdiDi>
    <tradeName>Eye Safety Two-Position, (577 nm)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Iridex Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000029814</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <emdnCode>Z12120280</emdnCode>
    <emdnDescription>THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>65472</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T20:38:30.021Z</lastUpdated>
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    <udiDi>00813125014506</udiDi>
    <basicUdiDi>081312501ESF8P</basicUdiDi>
    <tradeName>Eye Safety Two-Position,  (577 nm)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Iridex Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000029814</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <emdnDescription>THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>65473</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T20:38:30.002Z</lastUpdated>
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    <udiDi>00813125014513</udiDi>
    <basicUdiDi>081312501ESF8P</basicUdiDi>
    <tradeName>Eye Safety Two-Position,  (532 nm)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Iridex Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000029814</manufacturerSrn>
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    <emdnDescription>THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>65474</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T20:38:29.988Z</lastUpdated>
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    <udiDi>00813125014520</udiDi>
    <basicUdiDi>081312501ESF8P</basicUdiDi>
    <tradeName>Eye Safety Two-Position,  (532 nm)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Iridex Corporation</manufacturerName>
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    <emdnCode>Z12120280</emdnCode>
    <emdnDescription>THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>65475</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T20:38:29.972Z</lastUpdated>
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    <udiDi>00813125015039</udiDi>
    <basicUdiDi>081312501ESF8P</basicUdiDi>
    <tradeName>Eye Safety Filter, Fixed (577nm)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Iridex Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000029814</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <emdnCode>Z12120280</emdnCode>
    <emdnDescription>THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>65551</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T20:38:29.934Z</lastUpdated>
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