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    <deviceName>gigazyme</deviceName>
    <manufacturerName>Schülke &amp; Mayr GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005701</manufacturerSrn>
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    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>MDR 2017/745</legislation>
    <emdnCode>D0801</emdnCode>
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    <reference>70003408</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T19:21:08.814Z</lastUpdated>
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    <udiDi>04032651981137</udiDi>
    <basicUdiDi>4032651BSC00000062AG</basicUdiDi>
    <tradeName>thermosept X-tra enzymatic cleaner</tradeName>
    <deviceName>thermosept X-tra enzymatic cleaner</deviceName>
    <manufacturerName>Schülke &amp; Mayr GmbH</manufacturerName>
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    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnCode>D0801</emdnCode>
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    <reference>70003119</reference>
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    <lastUpdated>2026-07-30T19:21:02.412Z</lastUpdated>
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    <udiDi>04032651473014</udiDi>
    <basicUdiDi>4032651BSC00000058AR</basicUdiDi>
    <tradeName>thermosept alka clean forte</tradeName>
    <deviceName>thermosept alka clean forte</deviceName>
    <manufacturerName>Schülke &amp; Mayr GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005701</manufacturerSrn>
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    <lastUpdated>2026-07-30T19:20:44.799Z</lastUpdated>
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    <udiDi>10705037070718</udiDi>
    <basicUdiDi>0705037A180000000000018UM</basicUdiDi>
    <tradeName>CIDEZYME BIOCLEAN™ Enzymatic Detergent</tradeName>
    <deviceName>CIDEZYME BIOCLEAN™ Enzymatic Detergent</deviceName>
    <manufacturerName>Advanced Sterilization Products, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000008427</manufacturerSrn>
    <authorisedRepresentativeName>ASP, The Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002057</authorisedRepresentativeSrn>
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    <legislation>MDR 2017/745</legislation>
    <emdnCode>D0801</emdnCode>
    <emdnDescription>ENZYMATIC DETERGENTS FOR MEDICAL DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>88301</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-30T16:52:59.614Z</lastUpdated>
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    <udiDi>10705037018130</udiDi>
    <basicUdiDi>0705037A100000000000010HD</basicUdiDi>
    <tradeName>CIDEZYME™ Enzymatic Detergent 1L</tradeName>
    <deviceName>CIDEZYME™ Enzymatic Detergent</deviceName>
    <manufacturerName>Advanced Sterilization Products, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000008427</manufacturerSrn>
    <authorisedRepresentativeName>ASP, The Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002057</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>D0801</emdnCode>
    <emdnDescription>ENZYMATIC DETERGENTS FOR MEDICAL DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2258</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-30T16:52:50.702Z</lastUpdated>
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    <udiDi>04064797027264</udiDi>
    <basicUdiDi>++EPRM114DG</basicUdiDi>
    <tradeName>OMNI DENT Omnisuc Cleaner</tradeName>
    <deviceName>Absauganlagenreiniger D ZYME Konz., SSC 200 conc.</deviceName>
    <manufacturerName>PRISMAN GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000009900</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>D0801</emdnCode>
    <emdnDescription>ENZYMATIC DETERGENTS FOR MEDICAL DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>55153</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:17:01.646Z</lastUpdated>
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    <udiDi>04064797026328</udiDi>
    <basicUdiDi>++EPRM579EY</basicUdiDi>
    <tradeName>EuroseptXtra Thermo Cleaner Mild</tradeName>
    <deviceName>LavaPure Endosept C Konz.</deviceName>
    <manufacturerName>PRISMAN GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000009900</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>D0801</emdnCode>
    <emdnDescription>ENZYMATIC DETERGENTS FOR MEDICAL DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9889743</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:17:00.458Z</lastUpdated>
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    <udiDi>00724995356415</udiDi>
    <basicUdiDi>0724495PMPROTEDETERGTTJ</basicUdiDi>
    <tradeName>ISACLEAN AER</tradeName>
    <deviceName>ISACLEAN AER</deviceName>
    <manufacturerName>STERIS Italy S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000007606</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>D0801</emdnCode>
    <emdnDescription>ENZYMATIC DETERGENTS FOR MEDICAL DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4005635</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-29T19:52:52.871Z</lastUpdated>
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    <udiDi>00724995356644</udiDi>
    <basicUdiDi>0724495PMPROTEDETERGTTJ</basicUdiDi>
    <tradeName>ISACLEAN AER</tradeName>
    <deviceName></deviceName>
    <manufacturerName>STERIS Italy S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000007606</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>D0801</emdnCode>
    <emdnDescription>ENZYMATIC DETERGENTS FOR MEDICAL DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4005636</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T19:49:15.173Z</lastUpdated>
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    <basicUdiDi>0724495PMPROTEDETERGTTJ</basicUdiDi>
    <tradeName>ISACLEAN AER</tradeName>
    <deviceName></deviceName>
    <manufacturerName>STERIS Italy S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000007606</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>D0801</emdnCode>
    <emdnDescription>ENZYMATIC DETERGENTS FOR MEDICAL DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4005637</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T19:49:13.339Z</lastUpdated>
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    <udiDi>00724995356668</udiDi>
    <basicUdiDi>0724495PMPROTEDETERGTTJ</basicUdiDi>
    <tradeName>ISACLEAN AER</tradeName>
    <deviceName></deviceName>
    <manufacturerName>STERIS Italy S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000007606</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>D0801</emdnCode>
    <emdnDescription>ENZYMATIC DETERGENTS FOR MEDICAL DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4006082</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T19:49:13.200Z</lastUpdated>
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    <udiDi>05060722251215</udiDi>
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    <tradeName>Viruzyme</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Amity Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000023321</manufacturerSrn>
    <authorisedRepresentativeName>Amity Healthcare EU Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000011613</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>D0801</emdnCode>
    <emdnDescription>ENZYMATIC DETERGENTS FOR MEDICAL DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>J60B</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-25T13:38:53.945Z</lastUpdated>
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    <udiDi>05060722251239</udiDi>
    <basicUdiDi>506072225AAA0016JX</basicUdiDi>
    <tradeName>Viruzyme</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Amity Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000023321</manufacturerSrn>
    <authorisedRepresentativeName>Amity Healthcare EU Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000011613</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>D0801</emdnCode>
    <emdnDescription>ENZYMATIC DETERGENTS FOR MEDICAL DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>J60C</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-25T13:38:53.917Z</lastUpdated>
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    <udiDi>05060722251253</udiDi>
    <basicUdiDi>506072225AAA0016JX</basicUdiDi>
    <tradeName>Viruzyme</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Amity Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000023321</manufacturerSrn>
    <authorisedRepresentativeName>Amity Healthcare EU Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000011613</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>D0801</emdnCode>
    <emdnDescription>ENZYMATIC DETERGENTS FOR MEDICAL DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>J60D</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-25T13:38:53.879Z</lastUpdated>
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    <basicUdiDi>506072225AAA0016JX</basicUdiDi>
    <tradeName>Viruzyme III</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Amity Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000023321</manufacturerSrn>
    <authorisedRepresentativeName>Amity Healthcare EU Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000011613</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>D0801</emdnCode>
    <emdnDescription>ENZYMATIC DETERGENTS FOR MEDICAL DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>J62A</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-25T13:38:53.839Z</lastUpdated>
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    <udiDi>05060722251369</udiDi>
    <basicUdiDi>506072225AAA0016JX</basicUdiDi>
    <tradeName>Viruzyme III (non-fragrant)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Amity Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000023321</manufacturerSrn>
    <authorisedRepresentativeName>Amity Healthcare EU Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000011613</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>D0801</emdnCode>
    <emdnDescription>ENZYMATIC DETERGENTS FOR MEDICAL DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>J62ANF</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-25T13:38:53.799Z</lastUpdated>
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    <udiDi>05060722251376</udiDi>
    <basicUdiDi>506072225AAA0016JX</basicUdiDi>
    <tradeName>Viruzyme III (Non-Fragrant)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Amity Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000023321</manufacturerSrn>
    <authorisedRepresentativeName>Amity Healthcare EU Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000011613</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>D0801</emdnCode>
    <emdnDescription>ENZYMATIC DETERGENTS FOR MEDICAL DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>J62AAANF</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-25T13:38:53.722Z</lastUpdated>
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    <basicUdiDi>506072225AAA0016JX</basicUdiDi>
    <tradeName>Viruzyme III</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Amity Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000023321</manufacturerSrn>
    <authorisedRepresentativeName>Amity Healthcare EU Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000011613</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>D0801</emdnCode>
    <emdnDescription>ENZYMATIC DETERGENTS FOR MEDICAL DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>J62B</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-25T13:38:53.663Z</lastUpdated>
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    <udiDi>05060722251390</udiDi>
    <basicUdiDi>506072225AAA0016JX</basicUdiDi>
    <tradeName>Viruzyme III (non-fragrant)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Amity Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000023321</manufacturerSrn>
    <authorisedRepresentativeName>Amity Healthcare EU Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000011613</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>D0801</emdnCode>
    <emdnDescription>ENZYMATIC DETERGENTS FOR MEDICAL DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>J62BNF</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-25T13:38:53.613Z</lastUpdated>
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    <basicUdiDi>506072225AAA0016JX</basicUdiDi>
    <tradeName>Viruzyme III</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Amity Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000023321</manufacturerSrn>
    <authorisedRepresentativeName>Amity Healthcare EU Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000011613</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>D0801</emdnCode>
    <emdnDescription>ENZYMATIC DETERGENTS FOR MEDICAL DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>J62C</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-25T13:38:53.589Z</lastUpdated>
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