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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>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A01010302</emdnCode>
    <emdnDescription>NEEDLES AND KITS FOR IMPLANTABLE SYSTEMS (PORT), W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RHU-2025AHY</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T08:47:16.431Z</lastUpdated>
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    <manufacturerName>Promisemed Hangzhou Meditech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008465</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>RHU-2215AHY</reference>
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    <manufacturerName>Promisemed Hangzhou Meditech Co., Ltd.</manufacturerName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>RHU-2219AHY</reference>
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    <manufacturerName>Promisemed Hangzhou Meditech Co., Ltd.</manufacturerName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>RHU-2225AHY</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T08:47:16.369Z</lastUpdated>
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    <udiDi>06978111924482</udiDi>
    <basicUdiDi>697122740RHUR4</basicUdiDi>
    <tradeName>Lidem</tradeName>
    <deviceName></deviceName>
    <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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    <emdnDescription>NEEDLES AND KITS FOR IMPLANTABLE SYSTEMS (PORT), W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RHU-1938AH</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T08:47:16.227Z</lastUpdated>
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    <udiDi>06978111924499</udiDi>
    <basicUdiDi>697122740RHUR4</basicUdiDi>
    <tradeName>Lidem</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Promisemed Hangzhou Meditech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008465</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
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    <emdnDescription>NEEDLES AND KITS FOR IMPLANTABLE SYSTEMS (PORT), W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RHU-2038AH</reference>
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    <lastUpdated>2026-06-16T08:47:16.206Z</lastUpdated>
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    <udiDi>06978111924505</udiDi>
    <basicUdiDi>697122740RHUR4</basicUdiDi>
    <tradeName>Lidem</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Promisemed Hangzhou Meditech Co., Ltd.</manufacturerName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>RHU-2238AH</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T08:47:16.184Z</lastUpdated>
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    <udiDi>06978111924512</udiDi>
    <basicUdiDi>697122740RHUR4</basicUdiDi>
    <tradeName>Lidem</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Promisemed Hangzhou Meditech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008465</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
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    <emdnDescription>NEEDLES AND KITS FOR IMPLANTABLE SYSTEMS (PORT), W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RHU-1938AHY</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T08:47:16.163Z</lastUpdated>
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    <udiDi>06978111924529</udiDi>
    <basicUdiDi>697122740RHUR4</basicUdiDi>
    <tradeName>Lidem</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Promisemed Hangzhou Meditech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008465</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A01010302</emdnCode>
    <emdnDescription>NEEDLES AND KITS FOR IMPLANTABLE SYSTEMS (PORT), W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RHU-2038AHY</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T08:47:16.139Z</lastUpdated>
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    <udiDi>06978111924536</udiDi>
    <basicUdiDi>697122740RHUR4</basicUdiDi>
    <tradeName>Lidem</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Promisemed Hangzhou Meditech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008465</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A01010302</emdnCode>
    <emdnDescription>NEEDLES AND KITS FOR IMPLANTABLE SYSTEMS (PORT), W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RHU-2238AHY</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T08:47:16.115Z</lastUpdated>
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    <udiDi>06978111924543</udiDi>
    <basicUdiDi>697122740RHUR4</basicUdiDi>
    <tradeName>Lidem</tradeName>
    <deviceName></deviceName>
    <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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    <emdnCode>A01010302</emdnCode>
    <emdnDescription>NEEDLES AND KITS FOR IMPLANTABLE SYSTEMS (PORT), W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RHU-1938CH</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T08:47:16.092Z</lastUpdated>
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    <udiDi>06978111924550</udiDi>
    <basicUdiDi>697122740RHUR4</basicUdiDi>
    <tradeName>Lidem</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Promisemed Hangzhou Meditech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008465</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
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    <emdnDescription>NEEDLES AND KITS FOR IMPLANTABLE SYSTEMS (PORT), W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RHU-2038CH</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T08:47:16.067Z</lastUpdated>
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    <udiDi>06978111924567</udiDi>
    <basicUdiDi>697122740RHUR4</basicUdiDi>
    <tradeName>Lidem</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Promisemed Hangzhou Meditech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008465</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
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    <emdnDescription>NEEDLES AND KITS FOR IMPLANTABLE SYSTEMS (PORT), W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RHU-2238CH</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T08:47:16.048Z</lastUpdated>
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    <udiDi>06978111924574</udiDi>
    <basicUdiDi>697122740RHUR4</basicUdiDi>
    <tradeName>Lidem</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Promisemed Hangzhou Meditech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008465</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>RHU-1938CHY</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T08:47:16.026Z</lastUpdated>
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    <udiDi>06978111924581</udiDi>
    <basicUdiDi>697122740RHUR4</basicUdiDi>
    <tradeName>Lidem</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Promisemed Hangzhou Meditech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008465</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
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    <emdnDescription>NEEDLES AND KITS FOR IMPLANTABLE SYSTEMS (PORT), W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RHU-2038CHY</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T08:47:16.005Z</lastUpdated>
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    <udiDi>06978111924598</udiDi>
    <basicUdiDi>697122740RHUR4</basicUdiDi>
    <tradeName>Lidem</tradeName>
    <deviceName></deviceName>
    <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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    <emdnDescription>NEEDLES AND KITS FOR IMPLANTABLE SYSTEMS (PORT), W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RHU-2238CHY</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T08:47:15.983Z</lastUpdated>
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    <udiDi>06978111926271</udiDi>
    <basicUdiDi>697122740RHUR4</basicUdiDi>
    <tradeName>Verisafe</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Promisemed Hangzhou Meditech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008465</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
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    <emdnCode>A01010302</emdnCode>
    <emdnDescription>NEEDLES AND KITS FOR IMPLANTABLE SYSTEMS (PORT), W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RHU-1925AHY</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T08:47:15.275Z</lastUpdated>
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    <udiDi>06978111927261</udiDi>
    <basicUdiDi>697122740RHUR4</basicUdiDi>
    <tradeName>RHU-2238AH</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Promisemed Hangzhou Meditech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008465</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
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    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A01010302</emdnCode>
    <emdnDescription>NEEDLES AND KITS FOR IMPLANTABLE SYSTEMS (PORT), W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Verisafe</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T08:47:15.180Z</lastUpdated>
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    <udiDi>08056459679733</udiDi>
    <basicUdiDi>805645967NeedleCL</basicUdiDi>
    <tradeName>Huber Needle 19GA – 1’’ with extension</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PLAN 1 HEALTH S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000022746</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A01010302</emdnCode>
    <emdnDescription>NEEDLES AND KITS FOR IMPLANTABLE SYSTEMS (PORT), W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>201.11.59.12</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T03:56:22.571Z</lastUpdated>
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    <udiDi>08056459679757</udiDi>
    <basicUdiDi>805645967NeedleCL</basicUdiDi>
    <tradeName>Huber Needle 20GA – 0,75’’ with extension</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PLAN 1 HEALTH S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000022746</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A01010302</emdnCode>
    <emdnDescription>NEEDLES AND KITS FOR IMPLANTABLE SYSTEMS (PORT), W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>201.11.59.21</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T03:56:22.558Z</lastUpdated>
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