<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00020221900903</udiDi>
    <basicUdiDi>B-00020221900903</basicUdiDi>
    <tradeName>AmLUJECT DENTAL NDL. 30G X 21MM SHORT</tradeName>
    <deviceName>Dental 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>A010699</emdnCode>
    <emdnDescription>DENTISTRY NEEDLES AND KITS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>90090</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-04T06:05:28.577Z</lastUpdated>
  </row>
  <row>
    <udiDi>00020221900804</udiDi>
    <basicUdiDi>B-00020221900804</basicUdiDi>
    <tradeName>AmLUJECT DENTAL NDL. 27G X 32MM LONG</tradeName>
    <deviceName>Dental 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>A010699</emdnCode>
    <emdnDescription>DENTISTRY NEEDLES AND KITS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>90080</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-04T06:05:26.973Z</lastUpdated>
  </row>
  <row>
    <udiDi>00020221900705</udiDi>
    <basicUdiDi>B-00020221900705</basicUdiDi>
    <tradeName>AmLUJECT DENTAL NDL. 27G X 21MM SHORT</tradeName>
    <deviceName>Dental 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>A010699</emdnCode>
    <emdnDescription>DENTISTRY NEEDLES AND KITS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>90070</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-04T06:05:26.173Z</lastUpdated>
  </row>
  <row>
    <udiDi>00020221900606</udiDi>
    <basicUdiDi>B-00020221900606</basicUdiDi>
    <tradeName>AmLUJECT DENTAL NDL. 25G X 32MM LONG</tradeName>
    <deviceName>Dental 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>A010699</emdnCode>
    <emdnDescription>DENTISTRY NEEDLES AND KITS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>90060</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-04T06:05:24.578Z</lastUpdated>
  </row>
  <row>
    <udiDi>00020221900507</udiDi>
    <basicUdiDi>B-00020221900507</basicUdiDi>
    <tradeName>AmLUJECT DENTAL NDL. 25G X 21MM SHORT</tradeName>
    <deviceName>Dental 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>A010699</emdnCode>
    <emdnDescription>DENTISTRY NEEDLES AND KITS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>90050</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-04T06:05:22.169Z</lastUpdated>
  </row>
  <row>
    <udiDi>00020221900101</udiDi>
    <basicUdiDi>B-00020221900101</basicUdiDi>
    <tradeName>AmLUJECT DNTL NDL. 30G X 12MM  X-SHORT</tradeName>
    <deviceName>Dental 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>A010699</emdnCode>
    <emdnDescription>DENTISTRY NEEDLES AND KITS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>90010</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-04T06:05:20.576Z</lastUpdated>
  </row>
  <row>
    <udiDi>00020221861105</udiDi>
    <basicUdiDi>B-00020221861105</basicUdiDi>
    <tradeName>EXEL 2-3mL SYR 18GX1-1/2"</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>26110BST</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T06:05:19.770Z</lastUpdated>
  </row>
  <row>
    <udiDi>00020221765366</udiDi>
    <basicUdiDi>B-00020221765366</basicUdiDi>
    <tradeName>EXEL ABS M-S L- ADAPTER</tradeName>
    <deviceName>Luer Adapter</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>A070199</emdnCode>
    <emdnDescription>ADAPTERS AND CONNECTORS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>26536BS</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T06:05:18.173Z</lastUpdated>
  </row>
  <row>
    <udiDi>00020221762655</udiDi>
    <basicUdiDi>B-00020221762655</basicUdiDi>
    <tradeName>EXEL 10-12mL SYR L-L</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>26265BS</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T06:05:15.773Z</lastUpdated>
  </row>
  <row>
    <udiDi>00020221762303</udiDi>
    <basicUdiDi>B-00020221762303</basicUdiDi>
    <tradeName>EXEL 5-6mL SRY ONLY</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>26230BS</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T06:05:14.174Z</lastUpdated>
  </row>
  <row>
    <udiDi>00020221762006</udiDi>
    <basicUdiDi>B-00020221762006</basicUdiDi>
    <tradeName>EXEL 2-3mL SYR ONLY L-L</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>26200BS</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T06:05:13.374Z</lastUpdated>
  </row>
  <row>
    <udiDi>00020221665376</udiDi>
    <basicUdiDi>B-00020221665376</basicUdiDi>
    <tradeName>EXEL M-S L- ADAPTER</tradeName>
    <deviceName>Luer Adapter</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>A070199</emdnCode>
    <emdnDescription>ADAPTERS AND CONNECTORS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>26537A</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T06:05:11.774Z</lastUpdated>
  </row>
  <row>
    <udiDi>00020221663020</udiDi>
    <basicUdiDi>B-00020221663020</basicUdiDi>
    <tradeName>EXEL 50-60mL SYR ONLY CATH TIP WITH CAP, BULK NON-STERILE;</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>26302BN</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T06:05:09.372Z</lastUpdated>
  </row>
  <row>
    <udiDi>00020221665321</udiDi>
    <basicUdiDi>B-00020221665321</basicUdiDi>
    <tradeName>Holder with Luer Lock Multi Sample Luer Adapter</tradeName>
    <deviceName>Luer Holder</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>A01018099</emdnCode>
    <emdnDescription>NEEDLES FOR INFUSION AND COLLECTION - OTHER ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>26532BN</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T06:05:07.770Z</lastUpdated>
  </row>
  <row>
    <udiDi>00020221660289</udiDi>
    <basicUdiDi>B-00020221660289</basicUdiDi>
    <tradeName>EXEL 1/2mL INS SYR 29GX1/2"</tradeName>
    <deviceName>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>MDD</legislation>
    <emdnCode>A02010601</emdnCode>
    <emdnDescription>INSULIN SYRINGES WITH FIXED NEEDLE, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>26028BN</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T06:05:06.972Z</lastUpdated>
  </row>
  <row>
    <udiDi>00020221662924</udiDi>
    <basicUdiDi>B-00020221662924</basicUdiDi>
    <tradeName>EXEL 30-35mL SYR CATH.</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>26292BN</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T06:05:05.370Z</lastUpdated>
  </row>
  <row>
    <udiDi>00020221363005</udiDi>
    <basicUdiDi>B-00020221363005</basicUdiDi>
    <tradeName>EXEL 50ML SYRINGE L-L</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>26300BSNP</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T06:04:50.132Z</lastUpdated>
  </row>
  <row>
    <udiDi>00020221362909</udiDi>
    <basicUdiDi>B-00020221362909</basicUdiDi>
    <tradeName>EXEL 35ML SYRINGE L-L,</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>26290BSNP</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T06:04:48.511Z</lastUpdated>
  </row>
  <row>
    <udiDi>00020221362657</udiDi>
    <basicUdiDi>B-00020221362657</basicUdiDi>
    <tradeName>EXEL 10ML SYRINGE L-L</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>26265BSNP</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T06:04:47.723Z</lastUpdated>
  </row>
  <row>
    <udiDi>00020221362305</udiDi>
    <basicUdiDi>B-00020221362305</basicUdiDi>
    <tradeName>EXEL 5ML SYRINGE L-L</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>26230BSNP</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T06:04:46.107Z</lastUpdated>
  </row>
</eudamedExport>