<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00616258024318</udiDi>
    <basicUdiDi>0616258TFCN-0048QJ</basicUdiDi>
    <tradeName>Disposable MRI Kit for 65/115 MR Injector System</tradeName>
    <deviceName>MEDRAD® Spectris Solaris Sterile Disposables System Syringe Kit</deviceName>
    <manufacturerName>Bayer Medical Care Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007050</manufacturerSrn>
    <authorisedRepresentativeName>Bayer Medical Care B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000240</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A02010401</emdnCode>
    <emdnDescription>SYRINGES FOR CONTRAST MEDIA INJECTOR, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SSQK 65/115VS</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T22:05:06.839Z</lastUpdated>
  </row>
  <row>
    <udiDi>00616258024301</udiDi>
    <basicUdiDi>0616258TFCN-0002PS</basicUdiDi>
    <tradeName>Disposable MRI Kit with Check Valve</tradeName>
    <deviceName>MRI Integral “T” with Check Valve for MEDRAD® Spectris MR Injector</deviceName>
    <manufacturerName>Bayer Medical Care Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007050</manufacturerSrn>
    <authorisedRepresentativeName>Bayer Medical Care B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000240</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A02010401</emdnCode>
    <emdnDescription>SYRINGES FOR CONTRAST MEDIA INJECTOR, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SQK 65VS</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T22:05:06.065Z</lastUpdated>
  </row>
  <row>
    <udiDi>00616258022253</udiDi>
    <basicUdiDi>0616258TFCN-0090QH</basicUdiDi>
    <tradeName>MEDRAD® MRXperion MR Injection System Syringe Kit</tradeName>
    <deviceName>MEDRAD® MRXperion MR Injection System Syringe Kit</deviceName>
    <manufacturerName>Bayer Medical Care Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007050</manufacturerSrn>
    <authorisedRepresentativeName>Bayer Medical Care B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000240</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A02010401</emdnCode>
    <emdnDescription>SYRINGES FOR CONTRAST MEDIA INJECTOR, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XP 115VS</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T22:04:54.029Z</lastUpdated>
  </row>
  <row>
    <udiDi>00613703503008</udiDi>
    <basicUdiDi>0613703PatientSafePC</basicUdiDi>
    <tradeName>Patient Safe Syringe</tradeName>
    <deviceName>Patient Safe Syringe</deviceName>
    <manufacturerName>Retractable Technologies, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000031781</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A020102010202</emdnCode>
    <emdnDescription>INFUSION AND IRRIGATION SYRINGES, LUER CONE, 3-PIECE WITHOUT NEEDLE, SINGLE-USE</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>50301</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:53:59.970Z</lastUpdated>
  </row>
  <row>
    <udiDi>00613703101600</udiDi>
    <basicUdiDi>0613703VPsyringeF9</basicUdiDi>
    <tradeName>VanishPoint Syringe</tradeName>
    <deviceName>VanishPoint Syringe</deviceName>
    <manufacturerName>Retractable Technologies, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000031781</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A02010205</emdnCode>
    <emdnDescription>INFUSION AND IRRIGATION SYRINGES WITH SAFETY SYSTEM, SINGLE-USE</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>10161</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:53:54.363Z</lastUpdated>
  </row>
  <row>
    <udiDi>30383017593033</udiDi>
    <basicUdiDi>0383017SFTYINSYRNGAC</basicUdiDi>
    <tradeName>Ultra-Fine SAFETY Insulin Syringes</tradeName>
    <deviceName>Ultra-Fine SAFETY Insulin Syringes</deviceName>
    <manufacturerName>embecta Medical II LLC</manufacturerName>
    <manufacturerSrn>US-MF-000044225</manufacturerSrn>
    <authorisedRepresentativeName>embecta Penel Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000040945</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A0201060301</emdnCode>
    <emdnDescription>INSULIN SYRINGES WITH SAFETY SYSTEMS AND FIXED NEEDLES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>305930</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:51:02.317Z</lastUpdated>
  </row>
  <row>
    <udiDi>00383017667412</udiDi>
    <basicUdiDi>0383017INLSYRNGJR8V</basicUdiDi>
    <tradeName>Ultra-Fine Insulin Syringes</tradeName>
    <deviceName>Ultra-Fine</deviceName>
    <manufacturerName>embecta Medical II LLC</manufacturerName>
    <manufacturerSrn>US-MF-000044225</manufacturerSrn>
    <authorisedRepresentativeName>embecta Penel Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000040945</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A02010601</emdnCode>
    <emdnDescription>INSULIN SYRINGES WITH FIXED NEEDLE, SINGLE-USE</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>326674</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:44:56.123Z</lastUpdated>
  </row>
  <row>
    <udiDi>00383017080112</udiDi>
    <basicUdiDi>0383017INSLSYRNPBJR6K</basicUdiDi>
    <tradeName>Micro-Fine Insulin Syringes</tradeName>
    <deviceName>Micro-Fine; Ultra-Fine</deviceName>
    <manufacturerName>embecta Medical II LLC</manufacturerName>
    <manufacturerSrn>US-MF-000044225</manufacturerSrn>
    <authorisedRepresentativeName>embecta Penel Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000040945</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A02010601</emdnCode>
    <emdnDescription>INSULIN SYRINGES WITH FIXED NEEDLE, SINGLE-USE</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>320801</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:44:55.323Z</lastUpdated>
  </row>
  <row>
    <udiDi>10363807711607</udiDi>
    <basicUdiDi>0363807DC337ST7B</basicUdiDi>
    <tradeName>SwabFlush</tradeName>
    <deviceName>Swab flush</deviceName>
    <manufacturerName>Medline Industries, LP</manufacturerName>
    <manufacturerSrn>US-MF-000009717</manufacturerSrn>
    <authorisedRepresentativeName>Medline International France</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000001814</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>EMZG711600</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:20:56.144Z</lastUpdated>
  </row>
  <row>
    <udiDi>10363807007175</udiDi>
    <basicUdiDi>0363807DC335ST6Z</basicUdiDi>
    <tradeName>10363807007175</tradeName>
    <deviceName>Saline Flush</deviceName>
    <manufacturerName>Medline Industries, LP</manufacturerName>
    <manufacturerSrn>US-MF-000009717</manufacturerSrn>
    <authorisedRepresentativeName>Medline International France</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000001814</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>EMZCCS10500EU</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:20:53.880Z</lastUpdated>
  </row>
  <row>
    <udiDi>10304040133771</udiDi>
    <basicUdiDi>03040444901DN</basicUdiDi>
    <tradeName>Henry Schein</tradeName>
    <deviceName>Intra oral tip - Yellow</deviceName>
    <manufacturerName>Henry Schein Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000021683</manufacturerSrn>
    <authorisedRepresentativeName>Henry Schein Services GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000008001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A020199</emdnCode>
    <emdnDescription>SYRINGES, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9884290</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:20:22.962Z</lastUpdated>
  </row>
  <row>
    <udiDi>10304040116576</udiDi>
    <basicUdiDi>03040432701CK</basicUdiDi>
    <tradeName>Henry Schein</tradeName>
    <deviceName>Dental Syringes</deviceName>
    <manufacturerName>Henry Schein Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000021683</manufacturerSrn>
    <authorisedRepresentativeName>Henry Schein Services GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000008001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A020199</emdnCode>
    <emdnDescription>SYRINGES, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9006551</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:20:07.857Z</lastUpdated>
  </row>
  <row>
    <udiDi>10304040051624</udiDi>
    <basicUdiDi>03040445801DQ</basicUdiDi>
    <tradeName>Henry Schein</tradeName>
    <deviceName>Dental Needle Tips</deviceName>
    <manufacturerName>Henry Schein Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000021683</manufacturerSrn>
    <authorisedRepresentativeName>Henry Schein Services GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000008001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A020199</emdnCode>
    <emdnDescription>SYRINGES, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9004577</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:19:45.436Z</lastUpdated>
  </row>
  <row>
    <udiDi>06953124682024</udiDi>
    <basicUdiDi>69531246ZSS6E</basicUdiDi>
    <tradeName>Sterile Hypodermic Syringes for Single Use (without Needle)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jiangsu Zhengkang Medical Apparatus Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037484</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A020102010202</emdnCode>
    <emdnDescription>INFUSION AND IRRIGATION SYRINGES, 2-PIECE LUER CONE, 2-PIECE WITH NEEDLE, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2ml</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:01:55.790Z</lastUpdated>
  </row>
  <row>
    <udiDi>06953124682031</udiDi>
    <basicUdiDi>69531246ZSS6E</basicUdiDi>
    <tradeName>Sterile Hypodermic Syringes for Single Use (without Needle)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jiangsu Zhengkang Medical Apparatus Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037484</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A020102010202</emdnCode>
    <emdnDescription>INFUSION AND IRRIGATION SYRINGES, LUER LOCK CONE, 3-PIECE WITH NEEDLE, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3ml</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:01:55.542Z</lastUpdated>
  </row>
  <row>
    <udiDi>06953124682048</udiDi>
    <basicUdiDi>69531246ZSS6E</basicUdiDi>
    <tradeName>Sterile Hypodermic Syringes for Single Use (without Needle)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jiangsu Zhengkang Medical Apparatus Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037484</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A020102010202</emdnCode>
    <emdnDescription>INFUSION AND IRRIGATION SYRINGES, LUER LOCK CONE, 3-PIECE WITH NEEDLE, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5ml</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:01:55.065Z</lastUpdated>
  </row>
  <row>
    <udiDi>06953124682055</udiDi>
    <basicUdiDi>69531246ZSS6E</basicUdiDi>
    <tradeName>Sterile Hypodermic Syringes for Single Use (without Needle)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jiangsu Zhengkang Medical Apparatus Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037484</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A020102010202</emdnCode>
    <emdnDescription>INFUSION AND IRRIGATION SYRINGES, LUER LOCK CONE, 3-PIECE WITH NEEDLE, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10ml</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:01:54.465Z</lastUpdated>
  </row>
  <row>
    <udiDi>06953124682062</udiDi>
    <basicUdiDi>69531246ZSS6E</basicUdiDi>
    <tradeName>Sterile Hypodermic Syringes for Single Use (without Needle)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jiangsu Zhengkang Medical Apparatus Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037484</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A020102010202</emdnCode>
    <emdnDescription>INFUSION AND IRRIGATION SYRINGES, LUER LOCK CONE, 3-PIECE WITH NEEDLE, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20ml</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:01:53.881Z</lastUpdated>
  </row>
  <row>
    <udiDi>06953124682079</udiDi>
    <basicUdiDi>69531246ZSS6E</basicUdiDi>
    <tradeName>Sterile Hypodermic Syringes for Single Use (without Needle)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jiangsu Zhengkang Medical Apparatus Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037484</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A020102010202</emdnCode>
    <emdnDescription>INFUSION AND IRRIGATION SYRINGES, LUER LOCK CONE, 3-PIECE WITH NEEDLE, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30ml</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:01:53.175Z</lastUpdated>
  </row>
  <row>
    <udiDi>06953124682086</udiDi>
    <basicUdiDi>69531246ZSS6E</basicUdiDi>
    <tradeName>Sterile Hypodermic Syringes for Single Use (without Needle)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jiangsu Zhengkang Medical Apparatus Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037484</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A020102010202</emdnCode>
    <emdnDescription>INFUSION AND IRRIGATION SYRINGES, LUER LOCK CONE, 3-PIECE WITH NEEDLE, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50ml</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:01:52.668Z</lastUpdated>
  </row>
</eudamedExport>