<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>16972857292697</udiDi>
    <basicUdiDi>697285729052C</basicUdiDi>
    <tradeName>Safety Pen Needles</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sandstone Medical(Suzhou) Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000011105</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</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>SPN3005D</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T00:41:02.387Z</lastUpdated>
  </row>
  <row>
    <udiDi>16972857292703</udiDi>
    <basicUdiDi>697285729052C</basicUdiDi>
    <tradeName>Safety Pen Needles</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sandstone Medical(Suzhou) Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000011105</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</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>SPN3008D</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T00:41:02.356Z</lastUpdated>
  </row>
  <row>
    <udiDi>16972857292710</udiDi>
    <basicUdiDi>697285729052C</basicUdiDi>
    <tradeName>Safety Pen Needles</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sandstone Medical(Suzhou) Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000011105</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</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>SPN3108D</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T00:41:02.333Z</lastUpdated>
  </row>
  <row>
    <udiDi>16972857292727</udiDi>
    <basicUdiDi>697285729052C</basicUdiDi>
    <tradeName>Safety Pen Needles</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sandstone Medical(Suzhou) Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000011105</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</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>SPN3206D</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T00:41:02.310Z</lastUpdated>
  </row>
  <row>
    <udiDi>16972857292734</udiDi>
    <basicUdiDi>697285729052C</basicUdiDi>
    <tradeName>Safety Pen Needles</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sandstone Medical(Suzhou) Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000011105</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</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>SPN3304D</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T00:41:02.287Z</lastUpdated>
  </row>
  <row>
    <udiDi>16972857292741</udiDi>
    <basicUdiDi>697285729052C</basicUdiDi>
    <tradeName>Safety Pen Needles</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sandstone Medical(Suzhou) Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000011105</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A0101010201</emdnCode>
    <emdnDescription>HYPODERMIC PEN NEEDLES, WITH SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>05-3105</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T00:41:02.266Z</lastUpdated>
  </row>
  <row>
    <udiDi>16972857292802</udiDi>
    <basicUdiDi>6972857290124</basicUdiDi>
    <tradeName>Pen Needles</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sandstone Medical(Suzhou) Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000011105</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A0101010202</emdnCode>
    <emdnDescription>HYPODERMIC PEN NEEDLES, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HAR3204  32G×4mm</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T00:41:02.234Z</lastUpdated>
  </row>
  <row>
    <udiDi>16972857292819</udiDi>
    <basicUdiDi>6972857290124</basicUdiDi>
    <tradeName>Pen Needles</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sandstone Medical(Suzhou) Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000011105</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A0101010202</emdnCode>
    <emdnDescription>HYPODERMIC PEN NEEDLES, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HAR3105 31G×5mm</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T00:41:02.216Z</lastUpdated>
  </row>
  <row>
    <udiDi>16972857292826</udiDi>
    <basicUdiDi>697285729052C</basicUdiDi>
    <tradeName>Vitrex</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sandstone Medical(Suzhou) Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000011105</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</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>531113  30G×5mm</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T00:41:02.194Z</lastUpdated>
  </row>
  <row>
    <udiDi>16972857292833</udiDi>
    <basicUdiDi>697285729052C</basicUdiDi>
    <tradeName>Vitrex</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sandstone Medical(Suzhou) Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000011105</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</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>531213 30G×8mm</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T00:41:02.174Z</lastUpdated>
  </row>
  <row>
    <udiDi>16972857292840</udiDi>
    <basicUdiDi>697285729052C</basicUdiDi>
    <tradeName>Vitrex</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sandstone Medical(Suzhou) Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000011105</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</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>531313 31G×5mm</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T00:41:02.146Z</lastUpdated>
  </row>
  <row>
    <udiDi>16972857292857</udiDi>
    <basicUdiDi>697285729052C</basicUdiDi>
    <tradeName>Vitrex</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sandstone Medical(Suzhou) Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000011105</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</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>531413 31G×6mm</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T00:41:02.129Z</lastUpdated>
  </row>
  <row>
    <udiDi>16972857292864</udiDi>
    <basicUdiDi>697285729052C</basicUdiDi>
    <tradeName>Vitrex</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sandstone Medical(Suzhou) Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000011105</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</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>531513 32G×4mm</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T00:41:02.098Z</lastUpdated>
  </row>
  <row>
    <udiDi>16972857292871</udiDi>
    <basicUdiDi>6972857290124</basicUdiDi>
    <tradeName>Harmofine</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sandstone Medical(Suzhou) Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000011105</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A0101010202</emdnCode>
    <emdnDescription>HYPODERMIC PEN NEEDLES, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HAR3106</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T00:41:02.064Z</lastUpdated>
  </row>
  <row>
    <udiDi>16972857292888</udiDi>
    <basicUdiDi>6972857290124</basicUdiDi>
    <tradeName>Harmofine</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sandstone Medical(Suzhou) Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000011105</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A0101010202</emdnCode>
    <emdnDescription>HYPODERMIC PEN NEEDLES, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HAR3108</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T00:41:02.021Z</lastUpdated>
  </row>
  <row>
    <udiDi>16972857292895</udiDi>
    <basicUdiDi>6972857290124</basicUdiDi>
    <tradeName>Harmofine</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sandstone Medical(Suzhou) Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000011105</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A0101010202</emdnCode>
    <emdnDescription>HYPODERMIC PEN NEEDLES, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HAR2912</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T00:41:01.993Z</lastUpdated>
  </row>
  <row>
    <udiDi>16972857292901</udiDi>
    <basicUdiDi>6972857290124</basicUdiDi>
    <tradeName>Pen Needles</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sandstone Medical(Suzhou) Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000011105</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A0101010202</emdnCode>
    <emdnDescription>HYPODERMIC PEN NEEDLES, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01-3105</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T00:41:01.968Z</lastUpdated>
  </row>
  <row>
    <udiDi>16972857292918</udiDi>
    <basicUdiDi>6972857290124</basicUdiDi>
    <tradeName>Pen Needles</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sandstone Medical(Suzhou) Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000011105</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A0101010202</emdnCode>
    <emdnDescription>HYPODERMIC PEN NEEDLES, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>01-2912</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T00:41:01.938Z</lastUpdated>
  </row>
  <row>
    <udiDi>16972857293038</udiDi>
    <basicUdiDi>6972857290226</basicUdiDi>
    <tradeName>Pen Needles</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sandstone Medical(Suzhou) Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000011105</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A0101010202</emdnCode>
    <emdnDescription>HYPODERMIC PEN NEEDLES, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>IPN-33-4</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T00:41:01.920Z</lastUpdated>
  </row>
  <row>
    <udiDi>16972857293052</udiDi>
    <basicUdiDi>6972857290124</basicUdiDi>
    <tradeName>Pen Needle</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sandstone Medical(Suzhou) Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000011105</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A0101010202</emdnCode>
    <emdnDescription>HYPODERMIC PEN NEEDLES, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AP31G06</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T00:41:01.896Z</lastUpdated>
  </row>
</eudamedExport>