<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00020221264616</udiDi>
    <basicUdiDi>B-00020221264616</basicUdiDi>
    <tradeName>EXEL Aluminum Hub Needles 18G 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>26461</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T06:02:52.404Z</lastUpdated>
  </row>
  <row>
    <udiDi>00020221264586</udiDi>
    <basicUdiDi>B-00020221264586</basicUdiDi>
    <tradeName>EXEL Aluminum Hub Needles 16G X 1 1/2"</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>26458</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-04T06:02:48.413Z</lastUpdated>
  </row>
  <row>
    <udiDi>00020221264579</udiDi>
    <basicUdiDi>B-00020221264579</basicUdiDi>
    <tradeName>EXEL Aluminum Hub Needles 16G 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>26457</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T06:02:47.600Z</lastUpdated>
  </row>
  <row>
    <udiDi>00020221264562</udiDi>
    <basicUdiDi>B-00020221264562</basicUdiDi>
    <tradeName>EXEL Aluminum Hub Needles 16G 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>26456</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T06:02:46.794Z</lastUpdated>
  </row>
  <row>
    <udiDi>00020221264555</udiDi>
    <basicUdiDi>B-00020221264555</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>26455</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T06:02:46.111Z</lastUpdated>
  </row>
  <row>
    <udiDi>00020221264548</udiDi>
    <basicUdiDi>B-00020221264548</basicUdiDi>
    <tradeName>EXEL Aluminum Hub Needles 14G X 2"</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>26454</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T06:02:41.178Z</lastUpdated>
  </row>
  <row>
    <udiDi>00020221264524</udiDi>
    <basicUdiDi>B-00020221264524</basicUdiDi>
    <tradeName>EXEL Aluminum Hub Needles 14G X 1 1/2"</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>26452</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T06:02:40.386Z</lastUpdated>
  </row>
  <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>00020221262896</udiDi>
    <basicUdiDi>B-00020221262896</basicUdiDi>
    <tradeName>EXEL 20-25mL AMBER SYR ONLY L-L W/ TIP CAP</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>W01029004</emdnCode>
    <emdnDescription>COATED TUBES AND BEADS (UNASSIGNABLE) (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>26289</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T05:57:37.058Z</lastUpdated>
  </row>
  <row>
    <udiDi>00020221262889</udiDi>
    <basicUdiDi>B-00020221262889</basicUdiDi>
    <tradeName>EXEL 20-25mL AMBER SYR ONLY L-S W/ TIP CAP</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>W01029004</emdnCode>
    <emdnDescription>COATED TUBES AND BEADS (UNASSIGNABLE) (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>26288</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T05:57:36.260Z</lastUpdated>
  </row>
  <row>
    <udiDi>00020221262797</udiDi>
    <basicUdiDi>B-00020221262797</basicUdiDi>
    <tradeName>EXEL 20-25ml SYR L-L W/ ALUMINUM HUB NDL</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>26279</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T05:57:35.491Z</lastUpdated>
  </row>
  <row>
    <udiDi>00020221262698</udiDi>
    <basicUdiDi>B-00020221262698</basicUdiDi>
    <tradeName>EXEL 10-12mL AMBER SYR ONLY L-L W/ TIP CAP</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>W01029004</emdnCode>
    <emdnDescription>COATED TUBES AND BEADS (UNASSIGNABLE) (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>26269</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T05:57:34.659Z</lastUpdated>
  </row>
  <row>
    <udiDi>00020221262681</udiDi>
    <basicUdiDi>B-00020221262681</basicUdiDi>
    <tradeName>EXEL 10-12mL AMBER SYR ONLY L-S W/ TIP CAP</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>W01029004</emdnCode>
    <emdnDescription>COATED TUBES AND BEADS (UNASSIGNABLE) (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>26268</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T05:57:30.668Z</lastUpdated>
  </row>
  <row>
    <udiDi>00020221262674</udiDi>
    <basicUdiDi>B-00020221262674</basicUdiDi>
    <tradeName>EXEL CURVED TIP 10ml SYRINGE</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 I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A02010299</emdnCode>
    <emdnDescription>INFUSION AND IRRIGATION SYRINGES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>26267</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T05:57:29.847Z</lastUpdated>
  </row>
  <row>
    <udiDi>00020221262391</udiDi>
    <basicUdiDi>B-00020221262391</basicUdiDi>
    <tradeName>EXEL 5-6mL AMBER SYR ONLY L-L W/ TIP CAP</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>26239</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T05:57:29.048Z</lastUpdated>
  </row>
  <row>
    <udiDi>00020221262384</udiDi>
    <basicUdiDi>B-00020221262384</basicUdiDi>
    <tradeName>EXEL 5-6mL AMBER SYR ONLY L-S W/ TIP CAP</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>26238</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T05:57:28.251Z</lastUpdated>
  </row>
  <row>
    <udiDi>00020221262094</udiDi>
    <basicUdiDi>B-00020221262094</basicUdiDi>
    <tradeName>EXEL 2-3mL AMBER SYR ONLY L-L W/ TIP CAP</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>W01029004</emdnCode>
    <emdnDescription>COATED TUBES AND BEADS (UNASSIGNABLE) (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>26209</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T05:57:24.251Z</lastUpdated>
  </row>
</eudamedExport>