<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06944413855939</udiDi>
    <basicUdiDi>69444138isafePSBW</basicUdiDi>
    <tradeName>Blood Sampler</tradeName>
    <deviceName>Blood Sampler</deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A02010502</emdnCode>
    <emdnDescription>BLOOD GAS ANALYSIS, SYRINGES WITH SAFETY NEEDLE AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>isafeP-1-C1A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:44:20.079Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944413855922</udiDi>
    <basicUdiDi>69444138isafeAsC7</basicUdiDi>
    <tradeName>Blood Sampler</tradeName>
    <deviceName>Blood Sampler</deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A02010502</emdnCode>
    <emdnDescription>BLOOD GAS ANALYSIS, SYRINGES WITH SAFETY NEEDLE AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>isafeA-3-C5A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:44:18.896Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944413855915</udiDi>
    <basicUdiDi>69444138isafeAsC7</basicUdiDi>
    <tradeName>Blood Sampler</tradeName>
    <deviceName>Blood Sampler</deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A02010502</emdnCode>
    <emdnDescription>BLOOD GAS ANALYSIS, SYRINGES WITH SAFETY NEEDLE AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>isafeA-3-C2A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:44:12.901Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944413855908</udiDi>
    <basicUdiDi>69444138isafeAsC7</basicUdiDi>
    <tradeName>Blood Sampler</tradeName>
    <deviceName>Blood Sampler</deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A02010502</emdnCode>
    <emdnDescription>BLOOD GAS ANALYSIS, SYRINGES WITH SAFETY NEEDLE AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>isafeA-1-C4A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:44:11.686Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944413855892</udiDi>
    <basicUdiDi>69444138isafeAsC7</basicUdiDi>
    <tradeName>Blood Sampler</tradeName>
    <deviceName>Blood Sampler</deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A02010502</emdnCode>
    <emdnDescription>BLOOD GAS ANALYSIS, SYRINGES WITH SAFETY NEEDLE AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>isafeA-1-C2A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:44:10.592Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944413855885</udiDi>
    <basicUdiDi>69444138isafeAsC7</basicUdiDi>
    <tradeName>Blood Sampler</tradeName>
    <deviceName>Blood Sampler</deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A02010502</emdnCode>
    <emdnDescription>BLOOD GAS ANALYSIS, SYRINGES WITH SAFETY NEEDLE AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>isafeA-1-C1A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:44:08.073Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944413855328</udiDi>
    <basicUdiDi>69444138isafePSBW</basicUdiDi>
    <tradeName>Blood Sampler</tradeName>
    <deviceName>Blood Sampler</deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A02010502</emdnCode>
    <emdnDescription>BLOOD GAS ANALYSIS, SYRINGES WITH SAFETY NEEDLE AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>isafeP-3N</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:43:47.658Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944413855311</udiDi>
    <basicUdiDi>69444138isafePSBW</basicUdiDi>
    <tradeName>Blood Sampler</tradeName>
    <deviceName>Blood Sampler</deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A02010502</emdnCode>
    <emdnDescription>BLOOD GAS ANALYSIS, SYRINGES WITH SAFETY NEEDLE AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>isafeP-1N</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:43:41.655Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944413855304</udiDi>
    <basicUdiDi>69444138isafePSBW</basicUdiDi>
    <tradeName>Blood Sampler</tradeName>
    <deviceName>Blood Sampler</deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A02010502</emdnCode>
    <emdnDescription>BLOOD GAS ANALYSIS, SYRINGES WITH SAFETY NEEDLE AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>isafeP-3</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:43:40.454Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944413855298</udiDi>
    <basicUdiDi>69444138isafePSBW</basicUdiDi>
    <tradeName>Blood Sampler</tradeName>
    <deviceName>Blood Sampler</deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A02010502</emdnCode>
    <emdnDescription>BLOOD GAS ANALYSIS, SYRINGES WITH SAFETY NEEDLE AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>isafeP-1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:43:39.253Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944413855281</udiDi>
    <basicUdiDi>69444138isafeAsC7</basicUdiDi>
    <tradeName>Blood Sampler</tradeName>
    <deviceName>Blood Sampler</deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A02010502</emdnCode>
    <emdnDescription>BLOOD GAS ANALYSIS, SYRINGES WITH SAFETY NEEDLE AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>isafeA-3N</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:43:38.053Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944413855274</udiDi>
    <basicUdiDi>69444138isafeAsC7</basicUdiDi>
    <tradeName>Blood Sampler</tradeName>
    <deviceName>Blood Sampler</deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A02010502</emdnCode>
    <emdnDescription>BLOOD GAS ANALYSIS, SYRINGES WITH SAFETY NEEDLE AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>isafeA-1N</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:43:32.044Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944413855267</udiDi>
    <basicUdiDi>69444138isafeAsC7</basicUdiDi>
    <tradeName>Blood Sampler</tradeName>
    <deviceName>Blood Sampler</deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A02010502</emdnCode>
    <emdnDescription>BLOOD GAS ANALYSIS, SYRINGES WITH SAFETY NEEDLE AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>isafeA-3</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:43:30.846Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944413855250</udiDi>
    <basicUdiDi>69444138isafeAsC7</basicUdiDi>
    <tradeName>Blood Sampler</tradeName>
    <deviceName>Blood Sampler</deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A02010502</emdnCode>
    <emdnDescription>BLOOD GAS ANALYSIS, SYRINGES WITH SAFETY NEEDLE AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>isafeA-1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:43:29.752Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944413837966</udiDi>
    <basicUdiDi>69444138isafePSBW</basicUdiDi>
    <tradeName>Blood Sampler</tradeName>
    <deviceName>Blood Sampler</deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A02010502</emdnCode>
    <emdnDescription>BLOOD GAS ANALYSIS, SYRINGES WITH SAFETY NEEDLE AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>isafeP-3N</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:40:01.949Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944413837959</udiDi>
    <basicUdiDi>69444138isafePSBW</basicUdiDi>
    <tradeName>Blood Sampler</tradeName>
    <deviceName>Blood Sampler</deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A02010502</emdnCode>
    <emdnDescription>BLOOD GAS ANALYSIS, SYRINGES WITH SAFETY NEEDLE AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>isafeP-3N</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:40:00.754Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944413837935</udiDi>
    <basicUdiDi>69444138isafePSBW</basicUdiDi>
    <tradeName>Blood Sampler</tradeName>
    <deviceName>Blood Sampler</deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A02010502</emdnCode>
    <emdnDescription>BLOOD GAS ANALYSIS, SYRINGES WITH SAFETY NEEDLE AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>isafeP-1N</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:39:59.548Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944413837928</udiDi>
    <basicUdiDi>69444138isafePSBW</basicUdiDi>
    <tradeName>Blood Sampler</tradeName>
    <deviceName>Blood Sampler</deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A02010502</emdnCode>
    <emdnDescription>BLOOD GAS ANALYSIS, SYRINGES WITH SAFETY NEEDLE AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>isafeP-1N</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:39:58.340Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944413837904</udiDi>
    <basicUdiDi>69444138isafePSBW</basicUdiDi>
    <tradeName>Blood Sampler</tradeName>
    <deviceName>Blood Sampler</deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A02010502</emdnCode>
    <emdnDescription>BLOOD GAS ANALYSIS, SYRINGES WITH SAFETY NEEDLE AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>isafeP-3</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:39:52.440Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944413837898</udiDi>
    <basicUdiDi>69444138isafePSBW</basicUdiDi>
    <tradeName>Blood Sampler</tradeName>
    <deviceName>Blood Sampler</deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A02010502</emdnCode>
    <emdnDescription>BLOOD GAS ANALYSIS, SYRINGES WITH SAFETY NEEDLE AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>isafeP-3</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:39:48.737Z</lastUpdated>
  </row>
</eudamedExport>