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    <tradeName>VERISURE™ EO Type 4 Multi-Variable Chemical Indicator Strip</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Terragene S.A.</manufacturerName>
    <manufacturerSrn>AR-MF-000047833</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>S9080</emdnCode>
    <emdnDescription>DEVICES FOR STERILISATION (EXCLUDING CAT. D - Z) - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>73350</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:24:13.236Z</lastUpdated>
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    <udiDi>07798375772853</udiDi>
    <basicUdiDi>779816467CI5L</basicUdiDi>
    <tradeName>SEALSURE™ VH2O2 Indicator Tape 20mm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Terragene S.A.</manufacturerName>
    <manufacturerSrn>AR-MF-000047833</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
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    <lastUpdated>2026-07-03T19:24:13.209Z</lastUpdated>
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    <udiDi>07798375772891</udiDi>
    <basicUdiDi>779816467CI5L</basicUdiDi>
    <tradeName>VERISURE™ Steam Type 4 Multi-Variable Chemical Indicator</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Terragene S.A.</manufacturerName>
    <manufacturerSrn>AR-MF-000047833</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
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    <legislation>UNKNOWN</legislation>
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    <emdnDescription>DEVICES FOR STERILISATION (EXCLUDING CAT. D - Z) - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>73165</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:24:13.179Z</lastUpdated>
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    <udiDi>07798375772952</udiDi>
    <basicUdiDi>779816467CI5L</basicUdiDi>
    <tradeName>VERISURE™ Steam Type 5 Ink Integrator</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Terragene S.A.</manufacturerName>
    <manufacturerSrn>AR-MF-000047833</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>S9080</emdnCode>
    <emdnDescription>DEVICES FOR STERILISATION (EXCLUDING CAT. D - Z) - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>73156</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:24:13.153Z</lastUpdated>
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    <udiDi>07798375773348</udiDi>
    <basicUdiDi>779816467CI5L</basicUdiDi>
    <tradeName>VERISURE™ Wash &amp; Ultrasonic Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Terragene S.A.</manufacturerName>
    <manufacturerSrn>AR-MF-000047833</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>S9080</emdnCode>
    <emdnDescription>DEVICES FOR STERILISATION (EXCLUDING CAT. D - Z) - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>73600</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:24:13.126Z</lastUpdated>
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    <udiDi>07798375773416</udiDi>
    <basicUdiDi>779816467CI5L</basicUdiDi>
    <tradeName>VERISURE™ Ultrasonic Cavitation Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Terragene S.A.</manufacturerName>
    <manufacturerSrn>AR-MF-000047833</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>S9080</emdnCode>
    <emdnDescription>DEVICES FOR STERILISATION (EXCLUDING CAT. D - Z) - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>73620</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:24:13.095Z</lastUpdated>
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    <udiDi>07798375773560</udiDi>
    <basicUdiDi>779816467CI5L</basicUdiDi>
    <tradeName>BIOTRACE™ Protein Pen Surface Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Terragene S.A.</manufacturerName>
    <manufacturerSrn>AR-MF-000047833</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>S9080</emdnCode>
    <emdnDescription>DEVICES FOR STERILISATION (EXCLUDING CAT. D - Z) - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>73630</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:24:13.000Z</lastUpdated>
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    <udiDi>89061123275352</udiDi>
    <basicUdiDi>890611232RPILHG</basicUdiDi>
    <tradeName>ORO Process indicator Label Steam</tradeName>
    <deviceName>Process Indicator Label</deviceName>
    <manufacturerName>Reach Global India Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000041886</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>S9099</emdnCode>
    <emdnDescription>STERILISATION DEVICES (EXCLUDING CAT. D - Z) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RPILS</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:50:18.035Z</lastUpdated>
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    <udiDi>89061123264844</udiDi>
    <basicUdiDi>890611232RSMBDFW</basicUdiDi>
    <tradeName>ORO BOWIE DICK</tradeName>
    <deviceName>Bowie Dick</deviceName>
    <manufacturerName>Reach Global India Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000041886</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>S9099</emdnCode>
    <emdnDescription>STERILISATION DEVICES (EXCLUDING CAT. D - Z) - OTHER</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>RSMBD</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:50:10.826Z</lastUpdated>
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    <udiDi>89061123211510</udiDi>
    <basicUdiDi>890611232RSMITHK</basicUdiDi>
    <tradeName>ORO Indicator Tape Steam</tradeName>
    <deviceName>Indicator Tapes</deviceName>
    <manufacturerName>Reach Global India Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000041886</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>S9099</emdnCode>
    <emdnDescription>STERILISATION DEVICES (EXCLUDING CAT. D - Z) - OTHER</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>RSMSIT</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:49:49.155Z</lastUpdated>
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    <udiDi>08809416740782</udiDi>
    <basicUdiDi>880941674SA2L</basicUdiDi>
    <tradeName>SA-30</tradeName>
    <deviceName>Hydrogen Peroxide Sterilizing Agents for Use in Hydrogen Peorxide Sterilizers for Invasive and Non Invasive Medical Devcies</deviceName>
    <manufacturerName>LowTem Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000016177</manufacturerSrn>
    <authorisedRepresentativeName>Meridius Medical Europe Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000004258</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>S900101</emdnCode>
    <emdnDescription>HYDROGEN PEROXIDE CARTRIDGES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SA-30</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:57:07.294Z</lastUpdated>
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    <udiDi>08809416740478</udiDi>
    <basicUdiDi>880941674C120DW</basicUdiDi>
    <tradeName>LOWTEM Crystal 50</tradeName>
    <deviceName>Low temperature hydrogen peroxide sterilizers for invasive and non invasive medical device</deviceName>
    <manufacturerName>LowTem Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000016177</manufacturerSrn>
    <authorisedRepresentativeName>Meridius Medical Europe Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000004258</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>S900199</emdnCode>
    <emdnDescription>DEVICES FOR GAS PLASMA STERILISATION (EXCLUDING CAT. D - Z) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LOWTEM Crystal 50</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:57:06.863Z</lastUpdated>
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    <udiDi>08809293789423</udiDi>
    <basicUdiDi>880929378942P3</basicUdiDi>
    <tradeName>08809293789423</tradeName>
    <deviceName>Low Temperature Hydrogen Peroxide Sterilizer</deviceName>
    <manufacturerName>RENOSEM Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000023080</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>S900199</emdnCode>
    <emdnDescription>DEVICES FOR GAS PLASMA STERILISATION (EXCLUDING CAT. D - Z) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>REOM-011</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:54:30.216Z</lastUpdated>
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    <udiDi>08809293789348</udiDi>
    <basicUdiDi>880929378934P4</basicUdiDi>
    <tradeName>08809293789348</tradeName>
    <deviceName>HYDROGEN PEROXIDE CARTRIDGE</deviceName>
    <manufacturerName>RENOSEM Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000023080</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>S900101</emdnCode>
    <emdnDescription>HYDROGEN PEROXIDE CARTRIDGES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>REOM-005</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:50:39.609Z</lastUpdated>
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    <udiDi>08809293789324</udiDi>
    <basicUdiDi>880929378932NY</basicUdiDi>
    <tradeName>08809293789324</tradeName>
    <deviceName>HYDROGEN PEROXIDE CARTRIDGE</deviceName>
    <manufacturerName>RENOSEM Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000023080</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>S900101</emdnCode>
    <emdnDescription>HYDROGEN PEROXIDE CARTRIDGES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>REOM-009</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:50:37.194Z</lastUpdated>
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    <udiDi>08809293789300</udiDi>
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    <tradeName>08809293789300</tradeName>
    <deviceName>HYDROGEN PEROXIDE CARTRIDGE</deviceName>
    <manufacturerName>RENOSEM Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000023080</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>S900101</emdnCode>
    <emdnDescription>HYDROGEN PEROXIDE CARTRIDGES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>REOM-007</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:50:35.886Z</lastUpdated>
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    <udiDi>08809293789287</udiDi>
    <basicUdiDi>880929378928P9</basicUdiDi>
    <tradeName>08809293789287</tradeName>
    <deviceName>HYDROGEN PEROXIDE CARTRIDGE</deviceName>
    <manufacturerName>RENOSEM Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000023080</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>S900101</emdnCode>
    <emdnDescription>HYDROGEN PEROXIDE CARTRIDGES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>REOM-003</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:50:34.800Z</lastUpdated>
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    <udiDi>08809293788938</udiDi>
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    <tradeName>08809293788938</tradeName>
    <deviceName>Low Temperature Hydrogen Peroxide Sterilizer</deviceName>
    <manufacturerName>RENOSEM Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000023080</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>S900199</emdnCode>
    <emdnDescription>DEVICES FOR GAS PLASMA STERILISATION (EXCLUDING CAT. D - Z) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>REOM-010</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:50:33.233Z</lastUpdated>
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    <udiDi>08809293788884</udiDi>
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    <tradeName>08809293788884</tradeName>
    <deviceName>Low Temperature Hydrogen Peroxide Sterilizer</deviceName>
    <manufacturerName>RENOSEM Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000023080</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>S900199</emdnCode>
    <emdnDescription>DEVICES FOR GAS PLASMA STERILISATION (EXCLUDING CAT. D - Z) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>REOM-008</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:50:30.847Z</lastUpdated>
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    <udiDi>08809293788877</udiDi>
    <basicUdiDi>880929378887PL</basicUdiDi>
    <tradeName>08809293788877</tradeName>
    <deviceName>Low Temperature Hydrogen Peroxide Sterilizer</deviceName>
    <manufacturerName>RENOSEM Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000023080</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>S900199</emdnCode>
    <emdnDescription>DEVICES FOR GAS PLASMA STERILISATION (EXCLUDING CAT. D - Z) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>REOM-006</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:50:29.207Z</lastUpdated>
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