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    <tradeName>SPECULUM MONOUSO A PERNO MEDIUM</tradeName>
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    <manufacturerName>Kaltek S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000019573</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U089006</emdnCode>
    <emdnDescription>VAGINAL SPECULUM, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T04:05:49.661Z</lastUpdated>
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    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnDescription>VAGINAL SPECULUM, SINGLE-USE</emdnDescription>
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    <manufacturerName>Kaltek S.r.l.</manufacturerName>
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    <riskClass>Sınıf I</riskClass>
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    <tradeName>SPECULUM MONOUSO A VITE MEDIUM</tradeName>
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    <manufacturerName>Kaltek S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000019573</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
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    <emdnCode>U089006</emdnCode>
    <emdnDescription>VAGINAL SPECULUM, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T04:05:49.603Z</lastUpdated>
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    <udiDi>08055510560812</udiDi>
    <basicUdiDi>805551056speculum87</basicUdiDi>
    <tradeName>SPECULUM MONOUSO A VITE LARGE</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Kaltek S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000019573</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U089006</emdnCode>
    <emdnDescription>VAGINAL SPECULUM, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9198</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T04:05:49.587Z</lastUpdated>
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    <udiDi>08055510560898</udiDi>
    <basicUdiDi>805551056tempone_sterMU</basicUdiDi>
    <tradeName>TAMPONE IN LEGNO STERILE CF. 2 PZ</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Kaltek S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000019573</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>M010103</emdnCode>
    <emdnDescription>COTTON PAD</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2873 (5100/SG/2)</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T04:05:49.555Z</lastUpdated>
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    <udiDi>08055510560904</udiDi>
    <basicUdiDi>805551056tempone_sterMU</basicUdiDi>
    <tradeName>TAMPONE IN LEGNO STERILE CF. 10 PEZZI</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Kaltek S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000019573</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>M010103</emdnCode>
    <emdnDescription>COTTON PAD</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T04:05:49.539Z</lastUpdated>
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    <udiDi>08055510560911</udiDi>
    <basicUdiDi>805551056tempone_sterMU</basicUdiDi>
    <tradeName>TAMPONE IN PLASTICA STERILE CF. SINGOLA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Kaltek S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000019573</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>M010103</emdnCode>
    <emdnDescription>COTTON PAD</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3208 (6100/SG/CS)</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T04:05:49.520Z</lastUpdated>
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    <udiDi>08055510560928</udiDi>
    <basicUdiDi>805551056tempone_sterMU</basicUdiDi>
    <tradeName>TAMPONE VAGINALE MAXI STERILE</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Kaltek S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000019573</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>M010103</emdnCode>
    <emdnDescription>COTTON PAD</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2499</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T04:05:49.502Z</lastUpdated>
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    <udiDi>08055510560973</udiDi>
    <basicUdiDi>805551056speculum_ster45</basicUdiDi>
    <tradeName>SPECULUM MONOUSO STERILE CHIUSURA A VITE MEDIO</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Kaltek S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000019573</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U089006</emdnCode>
    <emdnDescription>VAGINAL SPECULUM, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0803</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T04:05:49.470Z</lastUpdated>
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    <udiDi>08055510560980</udiDi>
    <basicUdiDi>805551056speculum_ster45</basicUdiDi>
    <tradeName>SPECULUM MONOUSO STERILE CHIUSURA A VITE GRANDE</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Kaltek S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000019573</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U089006</emdnCode>
    <emdnDescription>VAGINAL SPECULUM, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0801</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T04:05:49.455Z</lastUpdated>
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    <udiDi>08055510560997</udiDi>
    <basicUdiDi>805551056speculum_ster45</basicUdiDi>
    <tradeName>SPECULUM MONOUSO STERILE CHIUSURA A PERNO MEDIO</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Kaltek S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000019573</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U089006</emdnCode>
    <emdnDescription>VAGINAL SPECULUM, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0813</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T04:05:49.441Z</lastUpdated>
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    <udiDi>08055510561000</udiDi>
    <basicUdiDi>805551056speculum_ster45</basicUdiDi>
    <tradeName>SPECULUM MONOUSO STERILE CHIUSURA A PERNO GRANDE</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Kaltek S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000019573</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U089006</emdnCode>
    <emdnDescription>VAGINAL SPECULUM, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0814</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T04:05:49.425Z</lastUpdated>
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    <udiDi>08055510561017</udiDi>
    <basicUdiDi>805551056speculum_ster45</basicUdiDi>
    <tradeName>SPECULUM MONOUSO STERILE CHIUSURA A PERNO PICCOLO</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Kaltek S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000019573</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U089006</emdnCode>
    <emdnDescription>VAGINAL SPECULUM, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2295</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T04:05:49.401Z</lastUpdated>
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    <udiDi>08055510561031</udiDi>
    <basicUdiDi>805551056abbassali_sterSM</basicUdiDi>
    <tradeName>ABBASSALINGUA STERILE IN PLASTICA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Kaltek S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000019573</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V9001</emdnCode>
    <emdnDescription>TONGUE DEPRESSORS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3711 (4002/SG/CS)</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T04:05:49.348Z</lastUpdated>
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    <udiDi>08055510563080</udiDi>
    <basicUdiDi>805551056cont_precarAT</basicUdiDi>
    <tradeName>CONTENITORE CON FORMALDEIDE AL 4%  ml. 10</tradeName>
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    <manufacturerName>Kaltek S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000019573</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W050301029099</emdnCode>
    <emdnDescription>SAMPLES ANALYSES, PLASTIC CONTAINERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-06-16T04:05:49.306Z</lastUpdated>
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    <udiDi>08055510563097</udiDi>
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    <tradeName>CONTENITORE CON FORMALDEIDE AL 4%   ml. 30</tradeName>
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    <manufacturerName>Kaltek S.r.l.</manufacturerName>
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    <emdnCode>W050301029099</emdnCode>
    <emdnDescription>SAMPLES ANALYSES, PLASTIC CONTAINERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-06-16T04:05:49.284Z</lastUpdated>
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    <tradeName>CONTENITORE CON FORMALDEIDE AL  4%   ml. 60</tradeName>
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    <manufacturerName>Kaltek S.r.l.</manufacturerName>
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    <emdnDescription>SAMPLES ANALYSES, PLASTIC CONTAINERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-06-16T04:05:49.264Z</lastUpdated>
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    <manufacturerName>Kaltek S.r.l.</manufacturerName>
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    <emdnCode>W050301029099</emdnCode>
    <emdnDescription>SAMPLES ANALYSES, PLASTIC CONTAINERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-06-16T04:05:49.244Z</lastUpdated>
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    <udiDi>08055510563127</udiDi>
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    <tradeName>CONTENITORE CON FORMALDEIDE AL 4%   ml. 250</tradeName>
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    <manufacturerName>Kaltek S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000019573</manufacturerSrn>
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    <emdnCode>W050301029099</emdnCode>
    <emdnDescription>SAMPLES ANALYSES, PLASTIC CONTAINERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1594</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
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