<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06978111920736</udiDi>
    <basicUdiDi>697122740RBCPE</basicUdiDi>
    <tradeName>unidix</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>A01010501</emdnCode>
    <emdnDescription>NEEDLES FOR COLLECTION UNDER VACUUM, WITH SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RBC-2119A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T08:47:18.842Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978111920743</udiDi>
    <basicUdiDi>697122740RBCPE</basicUdiDi>
    <tradeName>unidix</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>A01010501</emdnCode>
    <emdnDescription>NEEDLES FOR COLLECTION UNDER VACUUM, WITH SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RBC-2319A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T08:47:18.821Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978111920750</udiDi>
    <basicUdiDi>697122740RBCPE</basicUdiDi>
    <tradeName>unidix</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>A01010501</emdnCode>
    <emdnDescription>NEEDLES FOR COLLECTION UNDER VACUUM, WITH SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RBC-2519A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T08:47:18.803Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978111920804</udiDi>
    <basicUdiDi>697122740SLYU</basicUdiDi>
    <tradeName>Verifine</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>V010401</emdnCode>
    <emdnDescription>LANCETS WITH SAFETY SYSTEMS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SL-21-30M2</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T08:47:18.786Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978111920842</udiDi>
    <basicUdiDi>697122740IPNPZ</basicUdiDi>
    <tradeName>Sinofine</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>A0101010202</emdnCode>
    <emdnDescription>HYPODERMIC PEN NEEDLES, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IPN-31-5</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T08:47:18.768Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978111920859</udiDi>
    <basicUdiDi>697122740IPNPZ</basicUdiDi>
    <tradeName>Sinofine</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>A0101010202</emdnCode>
    <emdnDescription>HYPODERMIC PEN NEEDLES, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IPN-32-4</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T08:47:18.748Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978111920866</udiDi>
    <basicUdiDi>697122740IPNPZ</basicUdiDi>
    <tradeName>Sinofine</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>A0101010202</emdnCode>
    <emdnDescription>HYPODERMIC PEN NEEDLES, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IPN-32-4</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T08:47:18.731Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978111920873</udiDi>
    <basicUdiDi>697122740IPNPZ</basicUdiDi>
    <tradeName>Sinofine</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>A0101010202</emdnCode>
    <emdnDescription>HYPODERMIC PEN NEEDLES, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IPN-31-5</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T08:47:18.714Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978111920965</udiDi>
    <basicUdiDi>697122740SHUR9</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>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A01010301</emdnCode>
    <emdnDescription>NEEDLES AND KITS FOR IMPLANTABLE SYSTEMS (PORT), WITH SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SHU-1919CHY</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T08:47:18.696Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978111920972</udiDi>
    <basicUdiDi>697122740SHUR9</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>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A01010301</emdnCode>
    <emdnDescription>NEEDLES AND KITS FOR IMPLANTABLE SYSTEMS (PORT), WITH SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SHU-2015CHY</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T08:47:18.675Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978111920989</udiDi>
    <basicUdiDi>697122740SHUR9</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>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A01010301</emdnCode>
    <emdnDescription>NEEDLES AND KITS FOR IMPLANTABLE SYSTEMS (PORT), WITH SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SHU-2019CHY</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T08:47:18.652Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978111920996</udiDi>
    <basicUdiDi>697122740SHUR9</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>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A01010301</emdnCode>
    <emdnDescription>NEEDLES AND KITS FOR IMPLANTABLE SYSTEMS (PORT), WITH SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SHU-2025CHY</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T08:47:18.627Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978111921009</udiDi>
    <basicUdiDi>697122740SHUR9</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>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A01010301</emdnCode>
    <emdnDescription>NEEDLES AND KITS FOR IMPLANTABLE SYSTEMS (PORT), WITH SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SHU-2219CHY</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T08:47:18.600Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978111921016</udiDi>
    <basicUdiDi>697122740SHUR9</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>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A01010301</emdnCode>
    <emdnDescription>NEEDLES AND KITS FOR IMPLANTABLE SYSTEMS (PORT), WITH SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SHU-2225CHY</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T08:47:18.569Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978111921184</udiDi>
    <basicUdiDi>697122740IPNPZ</basicUdiDi>
    <tradeName>TonmiCare</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>A0101010202</emdnCode>
    <emdnDescription>HYPODERMIC PEN NEEDLES, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IPN-31-5</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T08:47:18.550Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978111921207</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>
    <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-2225AHY</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T08:47:18.521Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978111921351</udiDi>
    <basicUdiDi>697122740HBX7</basicUdiDi>
    <tradeName>unidix</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>V010401</emdnCode>
    <emdnDescription>LANCETS WITH SAFETY SYSTEMS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HB-065</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T08:47:18.500Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978111921368</udiDi>
    <basicUdiDi>697122740HBX7</basicUdiDi>
    <tradeName>unidix</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>V010401</emdnCode>
    <emdnDescription>LANCETS WITH SAFETY SYSTEMS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HB-085</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T08:47:18.476Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978111921375</udiDi>
    <basicUdiDi>697122740HBX7</basicUdiDi>
    <tradeName>unidix</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>V010401</emdnCode>
    <emdnDescription>LANCETS WITH SAFETY SYSTEMS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HB-100</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T08:47:18.451Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978111921382</udiDi>
    <basicUdiDi>697122740SLYU</basicUdiDi>
    <tradeName>Verifine</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>V010401</emdnCode>
    <emdnDescription>LANCETS WITH SAFETY SYSTEMS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SL-25-18M2</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T08:47:18.422Z</lastUpdated>
  </row>
</eudamedExport>