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    <tradeName>BAL Flush Spritze 3ml SS</tradeName>
    <deviceName>Pre-filled Flush Syringes</deviceName>
    <manufacturerName>Jiaxing Tianhe Pharmaceutical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000042578</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A02010701</emdnCode>
    <emdnDescription>PREFILLED SYRINGES WITH STERILE PHYSIOLOGICAL SOLUTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BAL360602001</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T15:32:30.217Z</lastUpdated>
  </row>
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    <udiDi>06937404203086</udiDi>
    <basicUdiDi>697525295PFSNSE</basicUdiDi>
    <tradeName>BAL Flush Spritze 3ml DS</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jiaxing Tianhe Pharmaceutical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000042578</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A02010701</emdnCode>
    <emdnDescription>PREFILLED SYRINGES WITH STERILE PHYSIOLOGICAL SOLUTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BAL360602002</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-24T19:59:41.094Z</lastUpdated>
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    <udiDi>06975252958901</udiDi>
    <basicUdiDi>697525295PFSNSE</basicUdiDi>
    <tradeName>BAL Flush Spritze 3ml SS</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jiaxing Tianhe Pharmaceutical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000042578</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A02010701</emdnCode>
    <emdnDescription>PREFILLED SYRINGES WITH STERILE PHYSIOLOGICAL SOLUTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>464011</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:35:14.119Z</lastUpdated>
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    <udiDi>06975252958918</udiDi>
    <basicUdiDi>697525295PFSNSE</basicUdiDi>
    <tradeName>BAL Flush Spritze 5ml SS</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jiaxing Tianhe Pharmaceutical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000042578</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A02010701</emdnCode>
    <emdnDescription>PREFILLED SYRINGES WITH STERILE PHYSIOLOGICAL SOLUTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>464012</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:35:14.101Z</lastUpdated>
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  <row>
    <udiDi>06975252958925</udiDi>
    <basicUdiDi>697525295PFSNSE</basicUdiDi>
    <tradeName>BAL Flush Spritze 10ml SS</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jiaxing Tianhe Pharmaceutical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000042578</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A02010701</emdnCode>
    <emdnDescription>PREFILLED SYRINGES WITH STERILE PHYSIOLOGICAL SOLUTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>464013</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:35:14.084Z</lastUpdated>
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  <row>
    <udiDi>06975252958932</udiDi>
    <basicUdiDi>697525295PFSNSE</basicUdiDi>
    <tradeName>BAL Flush Spritze 3ml DS</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jiaxing Tianhe Pharmaceutical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000042578</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A02010701</emdnCode>
    <emdnDescription>PREFILLED SYRINGES WITH STERILE PHYSIOLOGICAL SOLUTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>464015</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:35:14.069Z</lastUpdated>
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    <udiDi>06975252958949</udiDi>
    <basicUdiDi>697525295PFSNSE</basicUdiDi>
    <tradeName>BAL Flush Spritze 5ml DS</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jiaxing Tianhe Pharmaceutical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000042578</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A02010701</emdnCode>
    <emdnDescription>PREFILLED SYRINGES WITH STERILE PHYSIOLOGICAL SOLUTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>464016</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:35:14.059Z</lastUpdated>
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  <row>
    <udiDi>06975252958956</udiDi>
    <basicUdiDi>697525295PFSNSE</basicUdiDi>
    <tradeName>BAL Flush Spritze 10ml DS</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jiaxing Tianhe Pharmaceutical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000042578</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A02010701</emdnCode>
    <emdnDescription>PREFILLED SYRINGES WITH STERILE PHYSIOLOGICAL SOLUTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>464017</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:35:14.047Z</lastUpdated>
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