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    <tradeName>Betica</tradeName>
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    <manufacturerName>Promisemed Hangzhou Meditech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008465</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
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    <legislation>MDR 2017/745</legislation>
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    <emdnDescription>HYPODERMIC PEN NEEDLES, WITH SAFETY SYSTEMS</emdnDescription>
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    <reference>TPN-31*8Q</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T19:50:17.119Z</lastUpdated>
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    <basicUdiDi>590799609820MU</basicUdiDi>
    <tradeName>Safe Block</tradeName>
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    <manufacturerName>HTL-Strefa S.A.</manufacturerName>
    <manufacturerSrn>PL-MF-000002198</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>UNKNOWN</legislation>
    <emdnCode>A0101010201</emdnCode>
    <emdnDescription>HYPODERMIC PEN NEEDLES, WITH SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9600</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-29T09:00:16.759Z</lastUpdated>
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    <basicUdiDi>590799609820MU</basicUdiDi>
    <tradeName>Safe Block</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HTL-Strefa S.A.</manufacturerName>
    <manufacturerSrn>PL-MF-000002198</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnCode>A0101010201</emdnCode>
    <emdnDescription>HYPODERMIC PEN NEEDLES, WITH SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9601</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-29T09:00:16.741Z</lastUpdated>
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    <udiDi>05903999600396</udiDi>
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    <tradeName>Sicherheits-Pen-Nadeln</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HTL-Strefa S.A.</manufacturerName>
    <manufacturerSrn>PL-MF-000002198</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A0101010201</emdnCode>
    <emdnDescription>HYPODERMIC PEN NEEDLES, WITH SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7548</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T09:00:16.522Z</lastUpdated>
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    <udiDi>05903999600402</udiDi>
    <basicUdiDi>590799609820MU</basicUdiDi>
    <tradeName>Sicherheits-Pen-Nadeln</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HTL-Strefa S.A.</manufacturerName>
    <manufacturerSrn>PL-MF-000002198</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A0101010201</emdnCode>
    <emdnDescription>HYPODERMIC PEN NEEDLES, WITH SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7549</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T09:00:16.505Z</lastUpdated>
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    <udiDi>05903999600815</udiDi>
    <basicUdiDi>590799609820MU</basicUdiDi>
    <tradeName>DropSafe</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HTL-Strefa S.A.</manufacturerName>
    <manufacturerSrn>PL-MF-000002198</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A0101010201</emdnCode>
    <emdnDescription>HYPODERMIC PEN NEEDLES, WITH SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8298</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-29T09:00:16.434Z</lastUpdated>
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    <udiDi>05903999600822</udiDi>
    <basicUdiDi>590799609820MU</basicUdiDi>
    <tradeName>DropSafe</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HTL-Strefa S.A.</manufacturerName>
    <manufacturerSrn>PL-MF-000002198</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A0101010201</emdnCode>
    <emdnDescription>HYPODERMIC PEN NEEDLES, WITH SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8164</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-29T09:00:16.407Z</lastUpdated>
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    <udiDi>05903999600839</udiDi>
    <basicUdiDi>590799609820MU</basicUdiDi>
    <tradeName>DropSafe</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HTL-Strefa S.A.</manufacturerName>
    <manufacturerSrn>PL-MF-000002198</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A0101010201</emdnCode>
    <emdnDescription>HYPODERMIC PEN NEEDLES, WITH SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8165</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-29T09:00:16.385Z</lastUpdated>
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    <udiDi>05903999600914</udiDi>
    <basicUdiDi>590799609820MU</basicUdiDi>
    <tradeName>DropSafe</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HTL-Strefa S.A.</manufacturerName>
    <manufacturerSrn>PL-MF-000002198</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A0101010201</emdnCode>
    <emdnDescription>HYPODERMIC PEN NEEDLES, WITH SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8393</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T09:00:16.370Z</lastUpdated>
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    <udiDi>05903999600921</udiDi>
    <basicUdiDi>590799609820MU</basicUdiDi>
    <tradeName>DropSafe</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HTL-Strefa S.A.</manufacturerName>
    <manufacturerSrn>PL-MF-000002198</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A0101010201</emdnCode>
    <emdnDescription>HYPODERMIC PEN NEEDLES, WITH SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8394</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T09:00:16.351Z</lastUpdated>
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    <udiDi>05903999600938</udiDi>
    <basicUdiDi>590799609820MU</basicUdiDi>
    <tradeName>DropSafe</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HTL-Strefa S.A.</manufacturerName>
    <manufacturerSrn>PL-MF-000002198</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A0101010201</emdnCode>
    <emdnDescription>HYPODERMIC PEN NEEDLES, WITH SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8395</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T09:00:16.330Z</lastUpdated>
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    <udiDi>05903999603854</udiDi>
    <basicUdiDi>590799609820MU</basicUdiDi>
    <tradeName>diamet mySafety</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HTL-Strefa S.A.</manufacturerName>
    <manufacturerSrn>PL-MF-000002198</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A0101010201</emdnCode>
    <emdnDescription>HYPODERMIC PEN NEEDLES, WITH SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8445</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T09:00:15.874Z</lastUpdated>
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    <udiDi>05903999607357</udiDi>
    <basicUdiDi>590799609820MU</basicUdiDi>
    <tradeName>AutoProtect</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HTL-Strefa S.A.</manufacturerName>
    <manufacturerSrn>PL-MF-000002198</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A0101010201</emdnCode>
    <emdnDescription>HYPODERMIC PEN NEEDLES, WITH SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9624</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T09:00:13.076Z</lastUpdated>
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  <row>
    <udiDi>05903999607364</udiDi>
    <basicUdiDi>590799609820MU</basicUdiDi>
    <tradeName>AutoProtect</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HTL-Strefa S.A.</manufacturerName>
    <manufacturerSrn>PL-MF-000002198</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A0101010201</emdnCode>
    <emdnDescription>HYPODERMIC PEN NEEDLES, WITH SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9625</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T09:00:13.059Z</lastUpdated>
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    <udiDi>05903999608002</udiDi>
    <basicUdiDi>590799609820MU</basicUdiDi>
    <tradeName>AutoProtect</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HTL-Strefa S.A.</manufacturerName>
    <manufacturerSrn>PL-MF-000002198</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A0101010201</emdnCode>
    <emdnDescription>HYPODERMIC PEN NEEDLES, WITH SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9339</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T09:00:12.597Z</lastUpdated>
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    <udiDi>05903999608019</udiDi>
    <basicUdiDi>590799609820MU</basicUdiDi>
    <tradeName>AutoProtect</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HTL-Strefa S.A.</manufacturerName>
    <manufacturerSrn>PL-MF-000002198</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A0101010201</emdnCode>
    <emdnDescription>HYPODERMIC PEN NEEDLES, WITH SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9340</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T09:00:12.580Z</lastUpdated>
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  <row>
    <udiDi>06957138615993</udiDi>
    <basicUdiDi>69571386PN10WG</basicUdiDi>
    <tradeName>06957138615993</tradeName>
    <deviceName>Insulin Pen Needle</deviceName>
    <manufacturerName>Tianjin Huahong Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000015849</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A0101010201</emdnCode>
    <emdnDescription>HYPODERMIC PEN NEEDLES, WITH SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>No</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-29T01:23:11.306Z</lastUpdated>
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    <udiDi>06957138615702</udiDi>
    <basicUdiDi>69571386PD09VD</basicUdiDi>
    <tradeName>06957138615702</tradeName>
    <deviceName>Pen Needle</deviceName>
    <manufacturerName>Tianjin Huahong Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000015849</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A0101010201</emdnCode>
    <emdnDescription>HYPODERMIC PEN NEEDLES, WITH SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>No</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-29T01:22:30.467Z</lastUpdated>
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    <udiDi>06957138615696</udiDi>
    <basicUdiDi>69571386PD09VD</basicUdiDi>
    <tradeName>06957138615696</tradeName>
    <deviceName>Pen Needle</deviceName>
    <manufacturerName>Tianjin Huahong Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000015849</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A0101010201</emdnCode>
    <emdnDescription>HYPODERMIC PEN NEEDLES, WITH SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>No</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-29T01:22:29.271Z</lastUpdated>
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    <udiDi>06957138615429</udiDi>
    <basicUdiDi>69571386PD08VB</basicUdiDi>
    <tradeName>06957138615429</tradeName>
    <deviceName>Pen needle</deviceName>
    <manufacturerName>Tianjin Huahong Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000015849</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A0101010201</emdnCode>
    <emdnDescription>HYPODERMIC PEN NEEDLES, WITH SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>No</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-29T01:22:20.870Z</lastUpdated>
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