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    <tradeName>Safe Digites, safety lancet</tradeName>
    <deviceName>Safety lancet</deviceName>
    <manufacturerName>HTL-Strefa S.A.</manufacturerName>
    <manufacturerSrn>PL-MF-000002198</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V010401</emdnCode>
    <emdnDescription>LANCETS WITH SAFETY SYSTEMS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9609</reference>
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    <lastUpdated>2026-07-07T18:58:15.196Z</lastUpdated>
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    <udiDi>08058090024415</udiDi>
    <basicUdiDi>B-08058090024415</basicUdiDi>
    <tradeName>Safe Digites, safety lancet</tradeName>
    <deviceName>Safety lancet</deviceName>
    <manufacturerName>HTL-Strefa S.A.</manufacturerName>
    <manufacturerSrn>PL-MF-000002198</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnCode>V010401</emdnCode>
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    <reference>9610</reference>
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    <udiDi>08058090024408</udiDi>
    <basicUdiDi>B-08058090024408</basicUdiDi>
    <tradeName>Safe Digites, safety lancet</tradeName>
    <deviceName>Safety lancet</deviceName>
    <manufacturerName>HTL-Strefa S.A.</manufacturerName>
    <manufacturerSrn>PL-MF-000002198</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <lastUpdated>2026-07-07T18:58:11.183Z</lastUpdated>
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    <udiDi>08012992508657</udiDi>
    <basicUdiDi>B-08012992508657</basicUdiDi>
    <tradeName>Glucoject Lancets PLUS</tradeName>
    <deviceName>personal lancet</deviceName>
    <manufacturerName>HTL-Strefa S.A.</manufacturerName>
    <manufacturerSrn>PL-MF-000002198</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V010402</emdnCode>
    <emdnDescription>LANCETS WITHOUT SAFETY SYSTEMS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50865</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T08:46:19.519Z</lastUpdated>
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    <udiDi>08012992441244</udiDi>
    <basicUdiDi>B-08012992441244</basicUdiDi>
    <tradeName>Glucoject Lancets PLUS</tradeName>
    <deviceName>personal lancet</deviceName>
    <manufacturerName>HTL-Strefa S.A.</manufacturerName>
    <manufacturerSrn>PL-MF-000002198</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V010402</emdnCode>
    <emdnDescription>LANCETS WITHOUT SAFETY SYSTEMS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>44124</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T08:43:26.570Z</lastUpdated>
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    <udiDi>08012992441237</udiDi>
    <basicUdiDi>B-08012992441237</basicUdiDi>
    <tradeName>Glucoject Lancets PLUS</tradeName>
    <deviceName>personal lancet</deviceName>
    <manufacturerName>HTL-Strefa S.A.</manufacturerName>
    <manufacturerSrn>PL-MF-000002198</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V010402</emdnCode>
    <emdnDescription>LANCETS WITHOUT SAFETY SYSTEMS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>44123</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T08:43:25.755Z</lastUpdated>
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    <udiDi>08012992441213</udiDi>
    <basicUdiDi>B-08012992441213</basicUdiDi>
    <tradeName>Glucoject Lancets PLUS</tradeName>
    <deviceName>personal lancet</deviceName>
    <manufacturerName>HTL-Strefa S.A.</manufacturerName>
    <manufacturerSrn>PL-MF-000002198</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V010402</emdnCode>
    <emdnDescription>LANCETS WITHOUT SAFETY SYSTEMS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>44121</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T08:43:24.956Z</lastUpdated>
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    <udiDi>08012992441183</udiDi>
    <basicUdiDi>B-08012992441183</basicUdiDi>
    <tradeName>Glucoject Lancets PLUS</tradeName>
    <deviceName>personal lancet</deviceName>
    <manufacturerName>HTL-Strefa S.A.</manufacturerName>
    <manufacturerSrn>PL-MF-000002198</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V010402</emdnCode>
    <emdnDescription>LANCETS WITHOUT SAFETY SYSTEMS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>44118</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T08:43:20.953Z</lastUpdated>
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    <udiDi>08012992441145</udiDi>
    <basicUdiDi>B-08012992441145</basicUdiDi>
    <tradeName>Glucoject Lancets PLUS</tradeName>
    <deviceName>Personal lancet</deviceName>
    <manufacturerName>HTL-Strefa S.A.</manufacturerName>
    <manufacturerSrn>PL-MF-000002198</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V010402</emdnCode>
    <emdnDescription>LANCETS WITHOUT SAFETY SYSTEMS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>44114</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T08:43:20.156Z</lastUpdated>
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    <udiDi>08012992437094</udiDi>
    <basicUdiDi>B-08012992437094</basicUdiDi>
    <tradeName>Securlancets Unik</tradeName>
    <deviceName>Safety lancet</deviceName>
    <manufacturerName>HTL-Strefa S.A.</manufacturerName>
    <manufacturerSrn>PL-MF-000002198</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V010401</emdnCode>
    <emdnDescription>LANCETS WITH SAFETY SYSTEMS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7639</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T08:43:19.357Z</lastUpdated>
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    <udiDi>08012992437087</udiDi>
    <basicUdiDi>B-08012992437087</basicUdiDi>
    <tradeName>Securlancets Unik</tradeName>
    <deviceName>safety lancet</deviceName>
    <manufacturerName>HTL-Strefa S.A.</manufacturerName>
    <manufacturerSrn>PL-MF-000002198</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V010401</emdnCode>
    <emdnDescription>LANCETS WITH SAFETY SYSTEMS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7638</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-07T08:43:18.553Z</lastUpdated>
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    <udiDi>06950715563168</udiDi>
    <basicUdiDi>69507155CKIT4PH</basicUdiDi>
    <tradeName>blood glucose monitoring system</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Cofoe Medical Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001077</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>V010402</emdnCode>
    <emdnDescription>LANCETS WITHOUT SAFETY SYSTEMS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CGH11</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T08:08:13.127Z</lastUpdated>
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    <udiDi>06950715567821</udiDi>
    <basicUdiDi>69507155CKIT4PH</basicUdiDi>
    <tradeName>blood glucose monitoring system</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Cofoe Medical Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001077</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>V010402</emdnCode>
    <emdnDescription>LANCETS WITHOUT SAFETY SYSTEMS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CGH09</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T08:08:12.935Z</lastUpdated>
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    <udiDi>06950715570722</udiDi>
    <basicUdiDi>69507155CKIT4PH</basicUdiDi>
    <tradeName>blood glucose monitoring system</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Cofoe Medical Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001077</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>V010402</emdnCode>
    <emdnDescription>LANCETS WITHOUT SAFETY SYSTEMS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CGH10</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T08:08:12.896Z</lastUpdated>
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    <udiDi>06973004060780</udiDi>
    <basicUdiDi>B-06973004060780</basicUdiDi>
    <tradeName>Safety Lancet</tradeName>
    <deviceName>Blood Lancet for Single Use</deviceName>
    <manufacturerName>Guangzhou iCare Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000026220</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V010401</emdnCode>
    <emdnDescription>LANCETS WITH SAFETY SYSTEMS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SL031818</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T13:28:31.157Z</lastUpdated>
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    <udiDi>06973004060612</udiDi>
    <basicUdiDi>B-06973004060612</basicUdiDi>
    <tradeName>Safety Lancet</tradeName>
    <deviceName>Blood Lancet for Single Use</deviceName>
    <manufacturerName>Guangzhou iCare Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000026220</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V010401</emdnCode>
    <emdnDescription>LANCETS WITH SAFETY SYSTEMS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SL032618</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T13:28:29.560Z</lastUpdated>
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    <udiDi>06973004060568</udiDi>
    <basicUdiDi>B-06973004060568</basicUdiDi>
    <tradeName>Safety Lancet</tradeName>
    <deviceName>Blood Lancet for Single Use</deviceName>
    <manufacturerName>Guangzhou iCare Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000026220</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V010401</emdnCode>
    <emdnDescription>LANCETS WITH SAFETY SYSTEMS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SL032318</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T13:28:28.768Z</lastUpdated>
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    <udiDi>06973004060438</udiDi>
    <basicUdiDi>B-06973004060438</basicUdiDi>
    <tradeName>Safety Lancet</tradeName>
    <deviceName>Blood Lancet for Single Use</deviceName>
    <manufacturerName>Guangzhou iCare Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000026220</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V010401</emdnCode>
    <emdnDescription>LANCETS WITH SAFETY SYSTEMS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SL032118</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T13:28:27.268Z</lastUpdated>
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    <udiDi>06973004060223</udiDi>
    <basicUdiDi>B-06973004060223</basicUdiDi>
    <tradeName>Safety Lancet</tradeName>
    <deviceName>Blood Lancet for Single Use</deviceName>
    <manufacturerName>Guangzhou iCare Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000026220</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V010401</emdnCode>
    <emdnDescription>LANCETS WITH SAFETY SYSTEMS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SL033018</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T13:28:23.951Z</lastUpdated>
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    <udiDi>06973004060216</udiDi>
    <basicUdiDi>B-06973004060216</basicUdiDi>
    <tradeName>Safety Lancet</tradeName>
    <deviceName>Blood Lancet for Single Use</deviceName>
    <manufacturerName>Guangzhou iCare Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000026220</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V010401</emdnCode>
    <emdnDescription>LANCETS WITH SAFETY SYSTEMS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SL032818</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T13:28:22.356Z</lastUpdated>
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