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    <deviceName>VISIONLUX PLUS DUO</deviceName>
    <manufacturerName>Novax Pharma SAM</manufacturerName>
    <manufacturerSrn>MC-MF-000011256</manufacturerSrn>
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    <legislation>MDD</legislation>
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    <emdnDescription>EYE LUBRICANT SOLUTIONS</emdnDescription>
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    <reference>D10VXPD</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-13T11:15:40.397Z</lastUpdated>
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    <tradeName>VISIONLUX PLUS</tradeName>
    <deviceName>VISIONLUX PLUS</deviceName>
    <manufacturerName>Novax Pharma SAM</manufacturerName>
    <manufacturerSrn>MC-MF-000011256</manufacturerSrn>
    <authorisedRepresentativeName>International Associates Auditing &amp; Certification Limited</authorisedRepresentativeName>
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    <basicUdiDi>B-D10NPF3L</basicUdiDi>
    <tradeName>NAVITAE PLUS PF</tradeName>
    <deviceName>NAVITAE PLUS PF</deviceName>
    <manufacturerName>Novax Pharma SAM</manufacturerName>
    <manufacturerSrn>MC-MF-000011256</manufacturerSrn>
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    <placedOnMarketCountry>Lithuania</placedOnMarketCountry>
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    <udiDi>D-D10NLQK</udiDi>
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    <tradeName>NAVI®LIPO</tradeName>
    <deviceName>NAVILIPO - DROPS</deviceName>
    <manufacturerName>Novax Pharma SAM</manufacturerName>
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    <authorisedRepresentativeName>International Associates Auditing &amp; Certification Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000002248</authorisedRepresentativeSrn>
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    <emdnCode>Q02030206</emdnCode>
    <emdnDescription>EYE LUBRICANT SOLUTIONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D10NL</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-13T11:15:34.793Z</lastUpdated>
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    <udiDi>D-D10NCF2D</udiDi>
    <basicUdiDi>B-D10NCF2D</basicUdiDi>
    <tradeName>NAVI NACL 5% PF</tradeName>
    <deviceName>NAVI NACL 5% PF</deviceName>
    <manufacturerName>Novax Pharma SAM</manufacturerName>
    <manufacturerSrn>MC-MF-000011256</manufacturerSrn>
    <authorisedRepresentativeName>International Associates Auditing &amp; Certification Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000002248</authorisedRepresentativeSrn>
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    <legislation>MDD</legislation>
    <emdnCode>Q02030206</emdnCode>
    <emdnDescription>EYE LUBRICANT SOLUTIONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D10NCF</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-13T11:15:33.019Z</lastUpdated>
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    <udiDi>D-D10LXP4N</udiDi>
    <basicUdiDi>B-D10LXP4N</basicUdiDi>
    <tradeName>AEON PROTECT</tradeName>
    <deviceName>LUXYAL PLUS</deviceName>
    <manufacturerName>Novax Pharma SAM</manufacturerName>
    <manufacturerSrn>MC-MF-000011256</manufacturerSrn>
    <authorisedRepresentativeName>International Associates Auditing &amp; Certification Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000002248</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q02030206</emdnCode>
    <emdnDescription>EYE LUBRICANT SOLUTIONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D10LXP</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-13T11:15:31.819Z</lastUpdated>
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    <udiDi>07649990085098</udiDi>
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    <tradeName>VisionOne VFT</tradeName>
    <deviceName>VisionOne VFT</deviceName>
    <manufacturerName>PeriVision SA</manufacturerName>
    <manufacturerSrn>CH-MF-000047664</manufacturerSrn>
    <authorisedRepresentativeName>International Associates Auditing &amp; Certification Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000002248</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1212012092</emdnCode>
    <emdnDescription>INSTRUMENTS FOR THE ASSESSMENT OF VISUAL FUNCTIONALITY - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VO.004</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:51:16.914Z</lastUpdated>
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    <deviceName>Lens Holder</deviceName>
    <manufacturerName>PeriVision SA</manufacturerName>
    <manufacturerSrn>CH-MF-000047664</manufacturerSrn>
    <authorisedRepresentativeName>International Associates Auditing &amp; Certification Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000002248</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0299</emdnCode>
    <emdnDescription>OPHTHALMIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LH001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:51:12.890Z</lastUpdated>
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    <udiDi>07540161720292</udiDi>
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    <tradeName>07540161720292</tradeName>
    <deviceName>VersaTech Med-Surg XL 700</deviceName>
    <manufacturerName>Usine Rotec Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000022549</manufacturerSrn>
    <authorisedRepresentativeName>International Associates Auditing &amp; Certification Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000002248</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V08060105</emdnCode>
    <emdnDescription>ELECTRIC MEDICAL BEDS WITH WEIGHING SYSTEM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V7ULB+-EU-1110</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:16:09.817Z</lastUpdated>
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    <udiDi>07540161720261</udiDi>
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    <tradeName>07540161720261</tradeName>
    <deviceName>VersaTech Med-Surg 600</deviceName>
    <manufacturerName>Usine Rotec Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000022549</manufacturerSrn>
    <authorisedRepresentativeName>International Associates Auditing &amp; Certification Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000002248</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V08060105</emdnCode>
    <emdnDescription>ELECTRIC MEDICAL BEDS WITH WEIGHING SYSTEM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V6ULB+-EU-1000</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:16:09.018Z</lastUpdated>
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    <udiDi>07540161720216</udiDi>
    <basicUdiDi>754016172V11ULB+5N</basicUdiDi>
    <tradeName>07540161720216</tradeName>
    <deviceName>VersaTech Bariatric 1100</deviceName>
    <manufacturerName>Usine Rotec Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000022549</manufacturerSrn>
    <authorisedRepresentativeName>International Associates Auditing &amp; Certification Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000002248</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V08060106</emdnCode>
    <emdnDescription>BARIATRIC ELECTRIC MEDICAL BEDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V11ULB+-EU-1110</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:16:08.218Z</lastUpdated>
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    <udiDi>10692121035510</udiDi>
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    <tradeName>SleepRight</tradeName>
    <deviceName>SleepRight Snore Aid</deviceName>
    <manufacturerName>Splintek, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000012885</manufacturerSrn>
    <authorisedRepresentativeName>International Associates Auditing &amp; Certification Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000002248</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V9099</emdnCode>
    <emdnDescription>VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>many</reference>
    <placedOnMarketCountry>Estonia</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:18:40.791Z</lastUpdated>
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    <tradeName>SleepRight</tradeName>
    <deviceName>SleepRight Select-Comfort Dental Guard</deviceName>
    <manufacturerName>Splintek, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000012885</manufacturerSrn>
    <authorisedRepresentativeName>International Associates Auditing &amp; Certification Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000002248</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010699</emdnCode>
    <emdnDescription>MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>03543</reference>
    <placedOnMarketCountry>Estonia</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:18:39.994Z</lastUpdated>
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    <tradeName>SleepRight</tradeName>
    <deviceName>SleepRight ProRx Custom Dental Guard</deviceName>
    <manufacturerName>Splintek, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000012885</manufacturerSrn>
    <authorisedRepresentativeName>International Associates Auditing &amp; Certification Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000002248</authorisedRepresentativeSrn>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>03521</reference>
    <placedOnMarketCountry>Estonia</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:18:35.987Z</lastUpdated>
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    <tradeName>SleepRight</tradeName>
    <deviceName>SleepRight Dura-Comfort Dental Guard</deviceName>
    <manufacturerName>Splintek, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000012885</manufacturerSrn>
    <authorisedRepresentativeName>International Associates Auditing &amp; Certification Limited</authorisedRepresentativeName>
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    <lastUpdated>2026-07-02T06:18:35.181Z</lastUpdated>
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    <manufacturerName>Splintek, Inc.</manufacturerName>
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    <manufacturerName>Splintek, Inc.</manufacturerName>
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    <manufacturerName>Pragmatic Innovation Inc.</manufacturerName>
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    <manufacturerName>Runfold Plastics Ltd</manufacturerName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>MMA-900-0001</reference>
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    <lastUpdated>2026-07-01T23:00:48.590Z</lastUpdated>
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