<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00020221264517</udiDi>
    <basicUdiDi>B-00020221264517</basicUdiDi>
    <tradeName>EXEL Aluminum Hub Needles, 14G X 3/4"</tradeName>
    <deviceName>Aluminum Hub Needle</deviceName>
    <manufacturerName>Exelint International, Co.</manufacturerName>
    <manufacturerSrn>US-MF-000037396</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A0101010102</emdnCode>
    <emdnDescription>HYPODERMIC SYRINGE NEEDLES, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>26415</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T06:02:39.574Z</lastUpdated>
  </row>
  <row>
    <udiDi>00020221264500</udiDi>
    <basicUdiDi>B-00020221264500</basicUdiDi>
    <tradeName>EXEL Aluminum Hub Needles, 14G X 1"</tradeName>
    <deviceName>Aluminum Hub Needle</deviceName>
    <manufacturerName>Exelint International, Co.</manufacturerName>
    <manufacturerSrn>US-MF-000037396</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A0101010102</emdnCode>
    <emdnDescription>HYPODERMIC SYRINGE NEEDLES, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>26450</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T06:02:38.778Z</lastUpdated>
  </row>
  <row>
    <udiDi>00020221264234</udiDi>
    <basicUdiDi>B-00020221264234</basicUdiDi>
    <tradeName>EXEL HYPO NDL 16Gx3/4",</tradeName>
    <deviceName>Hypodermic Needle</deviceName>
    <manufacturerName>Exelint International, Co.</manufacturerName>
    <manufacturerSrn>US-MF-000037396</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A0101010102</emdnCode>
    <emdnDescription>HYPODERMIC SYRINGE NEEDLES, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>26423</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T05:57:41.864Z</lastUpdated>
  </row>
  <row>
    <udiDi>00020221264210</udiDi>
    <basicUdiDi>B-00020221264210</basicUdiDi>
    <tradeName>EXEL HYPO NDL 16G X 1",</tradeName>
    <deviceName>Hypodermic Needle</deviceName>
    <manufacturerName>Exelint International, Co.</manufacturerName>
    <manufacturerSrn>US-MF-000037396</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A0101010102</emdnCode>
    <emdnDescription>HYPODERMIC SYRINGE NEEDLES, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>26421</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T05:57:41.072Z</lastUpdated>
  </row>
  <row>
    <udiDi>00020221260632</udiDi>
    <basicUdiDi>B-00020221260632</basicUdiDi>
    <tradeName>EXEL 1mL ALLERGY SYR 27GX3/8", INTRADERMAL  BEVEL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Exelint International, Co.</manufacturerName>
    <manufacturerSrn>US-MF-000037396</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A0101010102</emdnCode>
    <emdnDescription>HYPODERMIC SYRINGE NEEDLES, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>26063</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T05:57:17.036Z</lastUpdated>
  </row>
  <row>
    <udiDi>00020221260625</udiDi>
    <basicUdiDi>B-00020221260625</basicUdiDi>
    <tradeName>EXEL 1mL ALLERGY SYR 27GX1/2"</tradeName>
    <deviceName>Allergy Syringe</deviceName>
    <manufacturerName>Exelint International, Co.</manufacturerName>
    <manufacturerSrn>US-MF-000037396</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A0101010102</emdnCode>
    <emdnDescription>HYPODERMIC SYRINGE NEEDLES, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>26062</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T05:57:16.249Z</lastUpdated>
  </row>
  <row>
    <udiDi>00020221260618</udiDi>
    <basicUdiDi>B-00020221260618</basicUdiDi>
    <tradeName>EXEL 1mL ALLERGY SYR 27GX1/2"</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Exelint International, Co.</manufacturerName>
    <manufacturerSrn>US-MF-000037396</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A0101010102</emdnCode>
    <emdnDescription>HYPODERMIC SYRINGE NEEDLES, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>26061</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T05:57:15.437Z</lastUpdated>
  </row>
  <row>
    <udiDi>00020221260595</udiDi>
    <basicUdiDi>B-00020221260595</basicUdiDi>
    <tradeName>EXEL 1mL LDS SYR 20G x 1"</tradeName>
    <deviceName>Syringe with needle</deviceName>
    <manufacturerName>Exelint International, Co.</manufacturerName>
    <manufacturerSrn>US-MF-000037396</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A0101010102</emdnCode>
    <emdnDescription>HYPODERMIC SYRINGE NEEDLES, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>26059</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T05:57:10.639Z</lastUpdated>
  </row>
  <row>
    <udiDi>00020221064636</udiDi>
    <basicUdiDi>B-00020221064636</basicUdiDi>
    <tradeName>EXEL Aluminum Hub Needles 18G X 5/8"</tradeName>
    <deviceName>Aluminum Hub Needle</deviceName>
    <manufacturerName>Exelint International, Co.</manufacturerName>
    <manufacturerSrn>US-MF-000037396</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A0101010102</emdnCode>
    <emdnDescription>HYPODERMIC SYRINGE NEEDLES, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>26463B</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T05:56:32.961Z</lastUpdated>
  </row>
  <row>
    <udiDi>00020221064551</udiDi>
    <basicUdiDi>B-00020221064551</basicUdiDi>
    <tradeName>EXEL Aluminum Hub Needles 16G X 5/8"</tradeName>
    <deviceName>Aluminum Hub Needle</deviceName>
    <manufacturerName>Exelint International, Co.</manufacturerName>
    <manufacturerSrn>US-MF-000037396</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A0101010102</emdnCode>
    <emdnDescription>HYPODERMIC SYRINGE NEEDLES, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>26455B</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-04T05:56:31.363Z</lastUpdated>
  </row>
  <row>
    <udiDi>00020221064483</udiDi>
    <basicUdiDi>B-00020221064483</basicUdiDi>
    <tradeName>EXEL HYPO NDL 28G X 3/4"</tradeName>
    <deviceName>Hypodermic Needle</deviceName>
    <manufacturerName>Exelint International, Co.</manufacturerName>
    <manufacturerSrn>US-MF-000037396</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A0101010102</emdnCode>
    <emdnDescription>HYPODERMIC SYRINGE NEEDLES, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>26448B</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T05:56:28.961Z</lastUpdated>
  </row>
  <row>
    <udiDi>00020221012163</udiDi>
    <basicUdiDi>B-00020221012163</basicUdiDi>
    <tradeName>Tandem Diabetes 5mL LL WITH CO-PACKED NEEDLE 26Gx3/8’’</tradeName>
    <deviceName>Syringe with needle</deviceName>
    <manufacturerName>Exelint International, Co.</manufacturerName>
    <manufacturerSrn>US-MF-000037396</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A0101010102</emdnCode>
    <emdnDescription>HYPODERMIC SYRINGE NEEDLES, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1001216</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T05:56:26.552Z</lastUpdated>
  </row>
  <row>
    <udiDi>00020221012156</udiDi>
    <basicUdiDi>B-00020221012156</basicUdiDi>
    <tradeName>Tandem Diabetes 3mL LL WITH CO-PACKED NEEDLE 26Gx3/8’’</tradeName>
    <deviceName>Syringe with needle</deviceName>
    <manufacturerName>Exelint International, Co.</manufacturerName>
    <manufacturerSrn>US-MF-000037396</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A0101010102</emdnCode>
    <emdnDescription>HYPODERMIC SYRINGE NEEDLES, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1001215</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T05:56:24.955Z</lastUpdated>
  </row>
  <row>
    <udiDi>89080170180990</udiDi>
    <basicUdiDi>8908017018HN014C</basicUdiDi>
    <tradeName>Nubeno</tradeName>
    <deviceName>Hypodermic Needle</deviceName>
    <manufacturerName>Nubeno Healthcare Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000014550</manufacturerSrn>
    <authorisedRepresentativeName>EUCEREP B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001966</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A0101010102</emdnCode>
    <emdnDescription>HYPODERMIC SYRINGE NEEDLES, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>IT-10</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:10:15.328Z</lastUpdated>
  </row>
  <row>
    <udiDi>08907265030006</udiDi>
    <basicUdiDi>8907265N0012Z</basicUdiDi>
    <tradeName>HYPODERMIC NEEDLE</tradeName>
    <deviceName>HYPODERMIC NEEDLE</deviceName>
    <manufacturerName>Romsons Group Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000036506</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A0101010102</emdnCode>
    <emdnDescription>HYPODERMIC SYRINGE NEEDLES, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SS-6088</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:04:37.961Z</lastUpdated>
  </row>
  <row>
    <udiDi>89044078019820</udiDi>
    <basicUdiDi>8904407810-410-25CR</basicUdiDi>
    <tradeName>Heuer</tradeName>
    <deviceName>Disposable Hypodermic Needle - 25G</deviceName>
    <manufacturerName>G.S.T. Corporation Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000040767</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A0101010102</emdnCode>
    <emdnDescription>HYPODERMIC SYRINGE NEEDLES, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10-410-25</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:40:45.771Z</lastUpdated>
  </row>
  <row>
    <udiDi>89044078019752</udiDi>
    <basicUdiDi>8904407810-410-22CK</basicUdiDi>
    <tradeName>Heuer</tradeName>
    <deviceName>Disposable Hypodermic Needle - 22G</deviceName>
    <manufacturerName>G.S.T. Corporation Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000040767</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A0101010102</emdnCode>
    <emdnDescription>HYPODERMIC SYRINGE NEEDLES, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10-410-22</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:40:44.167Z</lastUpdated>
  </row>
  <row>
    <udiDi>89044078019370</udiDi>
    <basicUdiDi>8904407810-410-21CH</basicUdiDi>
    <tradeName>Heuer</tradeName>
    <deviceName>Disposable Hypodermic Needle - 21G</deviceName>
    <manufacturerName>G.S.T. Corporation Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000040767</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A0101010102</emdnCode>
    <emdnDescription>HYPODERMIC SYRINGE NEEDLES, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10-410-21</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:40:41.798Z</lastUpdated>
  </row>
  <row>
    <udiDi>18903347000254</udiDi>
    <basicUdiDi>8903347A010101YK</basicUdiDi>
    <tradeName>DISPO VAN</tradeName>
    <deviceName>Hypodermic Needles</deviceName>
    <manufacturerName>Hindustan Syringes &amp; Medical Devices Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000019164</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A0101010102</emdnCode>
    <emdnDescription>HYPODERMIC SYRINGE NEEDLES, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>00025</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:28:23.172Z</lastUpdated>
  </row>
  <row>
    <udiDi>08904224801387</udiDi>
    <basicUdiDi>89042248HSY3V</basicUdiDi>
    <tradeName>ZENTRUM</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Iscon Surgicals Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000009761</manufacturerSrn>
    <authorisedRepresentativeName>Meddevices Lifesciences B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000594</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A0101010102</emdnCode>
    <emdnDescription>HYPODERMIC SYRINGE NEEDLES, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8904224801387</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:27:43.081Z</lastUpdated>
  </row>
</eudamedExport>