<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00020221260069</udiDi>
    <basicUdiDi>B-00020221260069</basicUdiDi>
    <tradeName>EXEL COMFORT POINT INSULIN PEN NDL 31G(0,25)x5/32"(4mm)</tradeName>
    <deviceName>Insulin Pen 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>A0101010202</emdnCode>
    <emdnDescription>HYPODERMIC PEN NEEDLES, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>26006</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T05:56:39.370Z</lastUpdated>
  </row>
  <row>
    <udiDi>00020221260052</udiDi>
    <basicUdiDi>B-00020221260052</basicUdiDi>
    <tradeName>EXEL COMFORT POINT INSULIN PEN NDL 31G(0,25)x1/3"(8mm)</tradeName>
    <deviceName>Insulin Pen 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>A0101010202</emdnCode>
    <emdnDescription>HYPODERMIC PEN NEEDLES, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>26005</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T05:56:37.763Z</lastUpdated>
  </row>
  <row>
    <udiDi>00020221260045</udiDi>
    <basicUdiDi>B-00020221260045</basicUdiDi>
    <tradeName>EXEL COMFORT POINT INSULIN PEN NDL 31G(0,25)x1/4"(6mm)</tradeName>
    <deviceName>Insulin Pen 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>A0101010202</emdnCode>
    <emdnDescription>HYPODERMIC PEN NEEDLES, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>26004</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T05:56:35.364Z</lastUpdated>
  </row>
  <row>
    <udiDi>00020221260038</udiDi>
    <basicUdiDi>B-00020221260038</basicUdiDi>
    <tradeName>EXEL COMFORT POINT INSULIN PEN NDL 29G(0,33)x1/2"(12mm)</tradeName>
    <deviceName>Insulin Pen 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>A0101010202</emdnCode>
    <emdnDescription>HYPODERMIC PEN NEEDLES, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>26003</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T05:56:33.770Z</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>00020221060508</udiDi>
    <basicUdiDi>B-00020221060508</basicUdiDi>
    <tradeName>SNAP 1ML LUER LOCK SYRINGE</tradeName>
    <deviceName>Syringe Only</deviceName>
    <manufacturerName>Exelint International, Co.</manufacturerName>
    <manufacturerSrn>US-MF-000037396</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A020199</emdnCode>
    <emdnDescription>SYRINGES, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>26050SNAP</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T05:56:27.361Z</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>10020221262671</udiDi>
    <basicUdiDi>20221CRVTIP262F2</basicUdiDi>
    <tradeName>EXEL Curved Tip Syringe</tradeName>
    <deviceName>EXEL Curved Tip 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 I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A02010299</emdnCode>
    <emdnDescription>INFUSION AND IRRIGATION SYRINGES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>26267</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-01T09:08:20.720Z</lastUpdated>
  </row>
  <row>
    <udiDi>10020221260615</udiDi>
    <basicUdiDi>20221SYRALG260KS</basicUdiDi>
    <tradeName>EXEL 1mL Allergy Syringes 27G x 1/2", Regular Bevel</tradeName>
    <deviceName>EXEL Allergy Syringes</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>MDR 2017/745</legislation>
    <emdnCode>A02010204</emdnCode>
    <emdnDescription>INFUSION AND IRRIGATION SYRINGES, WITHOUT CONE, WITH FIXED NEEDLE, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>26061</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-01T09:08:18.317Z</lastUpdated>
  </row>
  <row>
    <udiDi>10020221260103</udiDi>
    <basicUdiDi>20221SYRINS26015M</basicUdiDi>
    <tradeName>EXEL ComfortPoint Insulin Syringe - 0.3mL, 31G x 5/16"</tradeName>
    <deviceName>EXEL ComfortPoint Insulin 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>MDR 2017/745</legislation>
    <emdnCode>A02010601</emdnCode>
    <emdnDescription>INSULIN SYRINGES WITH FIXED NEEDLE, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>26010</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T09:08:16.712Z</lastUpdated>
  </row>
  <row>
    <udiDi>00020221295504</udiDi>
    <basicUdiDi>20221SCPL2953Z</basicUdiDi>
    <tradeName>EXEL Disposable Scalpel, Stainless Steel Size 10</tradeName>
    <deviceName>EXEL Disposable Scalpel</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>MDR 2017/745</legislation>
    <emdnCode>V010102</emdnCode>
    <emdnDescription>SCALPELS WITHOUT SAFETY SYSTEMS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>29550</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-01T09:02:52.326Z</lastUpdated>
  </row>
  <row>
    <udiDi>00020221295009</udiDi>
    <basicUdiDi>20221SURGBL295J4</basicUdiDi>
    <tradeName>EXEL Surgical Blade, Stainless Steel Size 10</tradeName>
    <deviceName>EXEL Surgical Blade</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>MDR 2017/745</legislation>
    <emdnCode>V010102</emdnCode>
    <emdnDescription>SCALPELS WITHOUT SAFETY SYSTEMS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>29500</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-01T09:02:50.619Z</lastUpdated>
  </row>
  <row>
    <udiDi>00020221277043</udiDi>
    <basicUdiDi>20221SFTSCLP277W9</basicUdiDi>
    <tradeName>EXEL SecureTouch Safety Scalp Vein Set 21G x 3/4", 12" Tube</tradeName>
    <deviceName>EXEL SecureTouch Safety Scalp Vein Set</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>MDR 2017/745</legislation>
    <emdnCode>A01010201</emdnCode>
    <emdnDescription>BUTTERFLY NEEDLES, WITH SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>27704</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T09:02:49.808Z</lastUpdated>
  </row>
  <row>
    <udiDi>00020221274035</udiDi>
    <basicUdiDi>20221HYPOSFT2742N</basicUdiDi>
    <tradeName>EXEL SecureTouch Safety Hypodermic Needle 25G x 5/8"</tradeName>
    <deviceName>EXEL SecureTouch Safety 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>MDR 2017/745</legislation>
    <emdnCode>A0101010101</emdnCode>
    <emdnDescription>HYPODERMIC SYRINGE NEEDLES, WITH SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>27403</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-01T09:02:49.029Z</lastUpdated>
  </row>
  <row>
    <udiDi>00020221270860</udiDi>
    <basicUdiDi>20221IVADM270Y6</basicUdiDi>
    <tradeName>EXEL IV Administration Set, Vented/Non-Vented with Needle-Free (Y) Injection Site, 78" Tubing, 15 Drop/mL Slip/Lock Connector</tradeName>
    <deviceName>EXEL IV Administration Set</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>MDR 2017/745</legislation>
    <emdnCode>A03040199</emdnCode>
    <emdnDescription>INFUSION KITS (WITH OR W/O PUMP), SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>27086</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-01T09:02:45.006Z</lastUpdated>
  </row>
  <row>
    <udiDi>00020221270426</udiDi>
    <basicUdiDi>20221SYRSFT261TX</basicUdiDi>
    <tradeName>EXEL Disposable Syringe with SecureTouch Safety Needle, 1mL Luer Lock Tip W/ 25G x 1"</tradeName>
    <deviceName>EXEL Disposable Syringe with SecureTouch Safety 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>MDR 2017/745</legislation>
    <emdnCode>A02010205</emdnCode>
    <emdnDescription>INFUSION AND IRRIGATION SYRINGES WITH SAFETY SYSTEM, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>27042</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-01T09:02:44.213Z</lastUpdated>
  </row>
  <row>
    <udiDi>00020221268362</udiDi>
    <basicUdiDi>20221WNDRS268C3</basicUdiDi>
    <tradeName>EXEL ZorBand Pressure Bandages, Extra Large</tradeName>
    <deviceName>EXEL ZorBand Pressure Bandages</deviceName>
    <manufacturerName>Exelint International, Co.</manufacturerName>
    <manufacturerSrn>US-MF-000037396</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>M04010102</emdnCode>
    <emdnDescription>POLYURETHANE (OR OTHER MATERIAL) ADHESIVE DRESSINGS, WITH ABSORBENT PAD</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>26836</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-01T09:02:43.417Z</lastUpdated>
  </row>
</eudamedExport>