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    <basicUdiDi>805551056tampprovsterYB</basicUdiDi>
    <tradeName>TAMPONE IN PROVETTA STERILE 12x150 ASTA IN PLASTICA</tradeName>
    <deviceName>TAMPONI IN PROVETTA STERILI</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>0824</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:34:11.515Z</lastUpdated>
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    <udiDi>08055510563349</udiDi>
    <basicUdiDi>805551056s_bag_2t_emoVD</basicUdiDi>
    <tradeName>SECUR BAG EMO 2T 300x520 mm</tradeName>
    <deviceName>SECUR-BAG EMO 2T</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>B0599</emdnCode>
    <emdnDescription>TOPICAL USE BLOOD COMPONENTS PREPARATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3875</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:34:09.914Z</lastUpdated>
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    <udiDi>08055510563073</udiDi>
    <basicUdiDi>805551056cont_precarAT</basicUdiDi>
    <tradeName>CONTENITORE CON FORMALDEIDE AL 4%  ml. 5</tradeName>
    <deviceName>CONTENITORE PRECARICATO CON FORMALDEIDE 4%</deviceName>
    <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>
    <reference>1590</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:34:09.224Z</lastUpdated>
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    <udiDi>08055510561024</udiDi>
    <basicUdiDi>805551056abbassali_sterSM</basicUdiDi>
    <tradeName>ABBASSALINGUA STERILE IN LEGNO</tradeName>
    <deviceName>ABBASSALINGUA STERILE</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>2470</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:34:06.728Z</lastUpdated>
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    <udiDi>08055510560966</udiDi>
    <basicUdiDi>805551056speculum_ster45</basicUdiDi>
    <tradeName>SPECULUM MONOUSO STERILE CHIUSURA A VITE PICCOLO</tradeName>
    <deviceName>SPECULUM MONOUSO STERILE CHIUSURA A VITE</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>0800</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:34:04.338Z</lastUpdated>
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    <udiDi>08055510560881</udiDi>
    <basicUdiDi>805551056tempone_sterMU</basicUdiDi>
    <tradeName>TAMPONE IN LEGNO STERILE CF. SINGOLA</tradeName>
    <deviceName>TAMPONI STERILI</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>0686 (5100/SG/CS)</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:34:02.708Z</lastUpdated>
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    <udiDi>08055510560768</udiDi>
    <basicUdiDi>805551056speculum87</basicUdiDi>
    <tradeName>SPECULUM MONOUSO A PERNO LARGE</tradeName>
    <deviceName>SPECULUM MONOUSO NON STERILE</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>9157</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:34:01.925Z</lastUpdated>
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    <udiDi>08055510560713</udiDi>
    <basicUdiDi>805551056enteroclismaEM</basicUdiDi>
    <tradeName>ENTEROCLISMA 2 LITRI COMPLETO</tradeName>
    <deviceName>Enteroclisma</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>V9002</emdnCode>
    <emdnDescription>ENTEROCLYSIS DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2202</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:34:00.307Z</lastUpdated>
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    <udiDi>08055510560676</udiDi>
    <basicUdiDi>805551056kryogelDE</basicUdiDi>
    <tradeName>GHIACCIO IN GEL KRYO GEL 11 x 26 cm</tradeName>
    <deviceName>KRYO GEL</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>M9001</emdnCode>
    <emdnDescription>CRYOTHERAPY AND THERMOTHERAPY DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3893</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:33:57.920Z</lastUpdated>
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    <udiDi>08055510560560</udiDi>
    <basicUdiDi>805551056padellaYE</basicUdiDi>
    <tradeName>PADELLA IN POLIPROPILENE</tradeName>
    <deviceName>PADELLA PLURIUSO</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>Y091299</emdnCode>
    <emdnDescription>DEJECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0645</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:33:56.302Z</lastUpdated>
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    <udiDi>08055510560409</udiDi>
    <basicUdiDi>805551056tapp_decont74</basicUdiDi>
    <tradeName>TAPPETO 30 STRAPPI AZZURRO 90 x 45</tradeName>
    <deviceName>TAPPETO DECONTAMINANTE</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>T030599</emdnCode>
    <emdnDescription>HEALTH SERVICE PREMISES PROTECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2835</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:33:55.504Z</lastUpdated>
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    <udiDi>08055510560324</udiDi>
    <basicUdiDi>805551056pappagalloJ8</basicUdiDi>
    <tradeName>PAPPAGALLO UOMO IN POLIETILENE</tradeName>
    <deviceName>PAPPAGALLO</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>Y091299</emdnCode>
    <emdnDescription>DEJECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0169</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:33:53.997Z</lastUpdated>
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    <udiDi>08055510560232</udiDi>
    <basicUdiDi>805551056kryo_ice9H</basicUdiDi>
    <tradeName>KRYO ICE</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Kaltek S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000019573</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>M9001</emdnCode>
    <emdnDescription>CRYOTHERAPY AND THERMOTHERAPY DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3819</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:33:50.713Z</lastUpdated>
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    <udiDi>08055510560249</udiDi>
    <basicUdiDi>805551056kryo_ice9H</basicUdiDi>
    <tradeName>Kryo ice</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Kaltek S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000019573</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>M9001</emdnCode>
    <emdnDescription>CRYOTHERAPY AND THERMOTHERAPY DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2211</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T04:05:50.253Z</lastUpdated>
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    <udiDi>08055510560256</udiDi>
    <basicUdiDi>805551056kryo_ice9H</basicUdiDi>
    <tradeName>KRYO ICE</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Kaltek S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000019573</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>M9001</emdnCode>
    <emdnDescription>CRYOTHERAPY AND THERMOTHERAPY DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2618</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T04:05:50.241Z</lastUpdated>
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    <udiDi>08055510560331</udiDi>
    <basicUdiDi>805551056pappagalloJ8</basicUdiDi>
    <tradeName>PAPPAGALLO UOMO IN POLIPROPILENE</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>Y091299</emdnCode>
    <emdnDescription>DEJECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4028</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T04:05:50.214Z</lastUpdated>
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    <udiDi>08055510560348</udiDi>
    <basicUdiDi>805551056pappagalloJ8</basicUdiDi>
    <tradeName>TAPPO PER PAPPAGALLO</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>Y091299</emdnCode>
    <emdnDescription>DEJECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0625</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T04:05:50.199Z</lastUpdated>
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    <udiDi>08055510560355</udiDi>
    <basicUdiDi>805551056pappagalloJ8</basicUdiDi>
    <tradeName>PAPPAGALLO UOMO IN POLIETILENE CON TAPPO</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>Y091299</emdnCode>
    <emdnDescription>DEJECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3400</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T04:05:50.180Z</lastUpdated>
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    <udiDi>08055510560362</udiDi>
    <basicUdiDi>805551056pappagalloJ8</basicUdiDi>
    <tradeName>PAPPAGALLO UOMO IN POLIPROPILENE CON TAPPO</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>Y091299</emdnCode>
    <emdnDescription>DEJECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5073</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T04:05:50.160Z</lastUpdated>
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    <udiDi>08055510560386</udiDi>
    <basicUdiDi>805551056pappagalloJ8</basicUdiDi>
    <tradeName>PAPPAGALLO DONNA</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>Y091299</emdnCode>
    <emdnDescription>DEJECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2988</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T04:05:50.137Z</lastUpdated>
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