<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00690521009332</udiDi>
    <basicUdiDi>6905210CAUT1000KF</basicUdiDi>
    <tradeName>00690521009332</tradeName>
    <deviceName>NON-STERILE CAUTERY TIP CLEANERS</deviceName>
    <manufacturerName>Batrik Medical Manufacturing Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000007738</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>M03030203</emdnCode>
    <emdnDescription>FOAM PADS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>60-10000</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:14:45.280Z</lastUpdated>
  </row>
  <row>
    <udiDi>00690521005464</udiDi>
    <basicUdiDi>6905210BRUSH10007A</basicUdiDi>
    <tradeName>00690521005464</tradeName>
    <deviceName>Brushes</deviceName>
    <manufacturerName>Batrik Medical Manufacturing Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000007738</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V070101</emdnCode>
    <emdnDescription>ENDOSCOPES CLEANING BRUSHES - FOR GENERIC USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>19-18010</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:14:41.296Z</lastUpdated>
  </row>
  <row>
    <udiDi>00690521004979</udiDi>
    <basicUdiDi>6905210PADLOK1000GL</basicUdiDi>
    <tradeName>00690521004979</tradeName>
    <deviceName>Padlock Security Tags</deviceName>
    <manufacturerName>Batrik Medical Manufacturing Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000007738</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>S9080</emdnCode>
    <emdnDescription>DEVICES FOR STERILISATION (EXCLUDING CAT. D - Z) - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>15-701-IND</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:14:40.475Z</lastUpdated>
  </row>
  <row>
    <udiDi>00690521002937</udiDi>
    <basicUdiDi>6905210IDTAPE1000EE</basicUdiDi>
    <tradeName>00690521002937</tradeName>
    <deviceName>S.T.I.C.S™ SIMPLE TRACKING IDENTIFICATION COLOR SYSTEM &amp; ID TAPE</deviceName>
    <manufacturerName>Batrik Medical Manufacturing Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000007738</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>H900299</emdnCode>
    <emdnDescription>TAPES, MEDICAL/SURGICAL - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>T-125-01</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:14:39.669Z</lastUpdated>
  </row>
  <row>
    <udiDi>00690521002838</udiDi>
    <basicUdiDi>6905210SKINSNS1000SN</basicUdiDi>
    <tradeName>00690521002838</tradeName>
    <deviceName>NON-STERILE SKINS™ Skin Markers</deviceName>
    <manufacturerName>Batrik Medical Manufacturing Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000007738</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V9004</emdnCode>
    <emdnDescription>SKIN MARKING DERMOGRAPHIC PENCILS AND PENS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S-93000</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:14:38.884Z</lastUpdated>
  </row>
  <row>
    <udiDi>07899439234413</udiDi>
    <basicUdiDi>B-07899439234413</basicUdiDi>
    <tradeName>SS Archwire Natural Lower 021X025 w/100</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Aditek do Brasil SA</manufacturerName>
    <manufacturerSrn>BR-MF-000018793</manufacturerSrn>
    <authorisedRepresentativeName>EC Certification Service GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>AT-AR-000006658</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09.05.0625.0</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:14:37.340Z</lastUpdated>
  </row>
  <row>
    <udiDi>07899439234420</udiDi>
    <basicUdiDi>B-07899439234420</basicUdiDi>
    <tradeName>SS Archwire Natural Lower 016X022 w/100</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Aditek do Brasil SA</manufacturerName>
    <manufacturerSrn>BR-MF-000018793</manufacturerSrn>
    <authorisedRepresentativeName>EC Certification Service GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>AT-AR-000006658</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09.05.0662.0</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:14:37.309Z</lastUpdated>
  </row>
  <row>
    <udiDi>07899439234437</udiDi>
    <basicUdiDi>B-07899439234437</basicUdiDi>
    <tradeName>SS Archwire Natural Lower 016X016 w/100</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Aditek do Brasil SA</manufacturerName>
    <manufacturerSrn>BR-MF-000018793</manufacturerSrn>
    <authorisedRepresentativeName>EC Certification Service GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>AT-AR-000006658</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09.05.0666.0</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:14:37.265Z</lastUpdated>
  </row>
  <row>
    <udiDi>07899439234444</udiDi>
    <basicUdiDi>B-07899439234444</basicUdiDi>
    <tradeName>SS Archwire Natural Lower 017X025 w/100</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Aditek do Brasil SA</manufacturerName>
    <manufacturerSrn>BR-MF-000018793</manufacturerSrn>
    <authorisedRepresentativeName>EC Certification Service GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>AT-AR-000006658</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09.05.0675.0</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:14:37.229Z</lastUpdated>
  </row>
  <row>
    <udiDi>07899439234451</udiDi>
    <basicUdiDi>B-07899439234451</basicUdiDi>
    <tradeName>SS Archwire Natural Lower 018X025 w/100</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Aditek do Brasil SA</manufacturerName>
    <manufacturerSrn>BR-MF-000018793</manufacturerSrn>
    <authorisedRepresentativeName>EC Certification Service GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>AT-AR-000006658</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09.05.0685.0</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:14:37.200Z</lastUpdated>
  </row>
  <row>
    <udiDi>07899439234468</udiDi>
    <basicUdiDi>B-07899439234468</basicUdiDi>
    <tradeName>SS Archwire Natural Lower 019X025 w/100</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Aditek do Brasil SA</manufacturerName>
    <manufacturerSrn>BR-MF-000018793</manufacturerSrn>
    <authorisedRepresentativeName>EC Certification Service GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>AT-AR-000006658</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09.05.0695.0</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:14:37.153Z</lastUpdated>
  </row>
  <row>
    <udiDi>07899439234482</udiDi>
    <basicUdiDi>B-07899439234482</basicUdiDi>
    <tradeName>SS Archwire Universal L 019X025 w/10</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Aditek do Brasil SA</manufacturerName>
    <manufacturerSrn>BR-MF-000018793</manufacturerSrn>
    <authorisedRepresentativeName>EC Certification Service GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>AT-AR-000006658</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ORTHODONTIC WIRES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09.05.0995</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:14:37.120Z</lastUpdated>
  </row>
  <row>
    <udiDi>07899439234499</udiDi>
    <basicUdiDi>B-07899439234499</basicUdiDi>
    <tradeName>SS Archwire Universal M 019X025 w/10</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Aditek do Brasil SA</manufacturerName>
    <manufacturerSrn>BR-MF-000018793</manufacturerSrn>
    <authorisedRepresentativeName>EC Certification Service GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>AT-AR-000006658</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ORTHODONTIC WIRES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09.05.0895</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:14:37.092Z</lastUpdated>
  </row>
  <row>
    <udiDi>07899439234505</udiDi>
    <basicUdiDi>B-07899439234505</basicUdiDi>
    <tradeName>SS Archwire Universal S 019X025 w/10</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Aditek do Brasil SA</manufacturerName>
    <manufacturerSrn>BR-MF-000018793</manufacturerSrn>
    <authorisedRepresentativeName>EC Certification Service GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>AT-AR-000006658</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ORTHODONTIC WIRES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09.05.0795</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:14:37.045Z</lastUpdated>
  </row>
  <row>
    <udiDi>07899439234703</udiDi>
    <basicUdiDi>B-07899439234703</basicUdiDi>
    <tradeName>SS Archwire Natural Lower 017X025 w/20</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Aditek do Brasil SA</manufacturerName>
    <manufacturerSrn>BR-MF-000018793</manufacturerSrn>
    <authorisedRepresentativeName>EC Certification Service GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>AT-AR-000006658</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09.05.0675.2</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:14:36.980Z</lastUpdated>
  </row>
  <row>
    <udiDi>00690521002784</udiDi>
    <basicUdiDi>6905210SKINSST100AL</basicUdiDi>
    <tradeName>00690521002784</tradeName>
    <deviceName>Sterile SKINS™ Skin Markers</deviceName>
    <manufacturerName>Batrik Medical Manufacturing Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000007738</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V9004</emdnCode>
    <emdnDescription>SKIN MARKING DERMOGRAPHIC PENCILS AND PENS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S-30005</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:14:34.869Z</lastUpdated>
  </row>
  <row>
    <udiDi>00690521000834</udiDi>
    <basicUdiDi>6905210TOURNY1000G3</basicUdiDi>
    <tradeName>00690521000834</tradeName>
    <deviceName>TOURNY™ + TOURNIQUETS</deviceName>
    <manufacturerName>Batrik Medical Manufacturing Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000007738</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V9003</emdnCode>
    <emdnDescription>TOURNIQUETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K-002</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:14:34.059Z</lastUpdated>
  </row>
  <row>
    <udiDi>00690521000469</udiDi>
    <basicUdiDi>6905210INSTPRO1000V4</basicUdiDi>
    <tradeName>00690521000469</tradeName>
    <deviceName>Instrument Protectors (including Osteotome Protectors, Double Protectors, &amp; Retractor Protectors)</deviceName>
    <manufacturerName>Batrik Medical Manufacturing Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000007738</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V9099</emdnCode>
    <emdnDescription>VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DG-01</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:14:33.261Z</lastUpdated>
  </row>
  <row>
    <udiDi>00690521000162</udiDi>
    <basicUdiDi>6905210BITEB1000RK</basicUdiDi>
    <tradeName>00690521000162</tradeName>
    <deviceName>Bite Blocks</deviceName>
    <manufacturerName>Batrik Medical Manufacturing Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000007738</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G030804</emdnCode>
    <emdnDescription>GASTROINTESTINAL ENDOSCOPY AND ECHOENDOSCOPY, BITE BLOCKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BS</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:14:32.466Z</lastUpdated>
  </row>
  <row>
    <udiDi>07899439258310</udiDi>
    <basicUdiDi>B-07899439258310</basicUdiDi>
    <tradeName>SS Archwire Natural Lower 016X022 w/10</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Aditek do Brasil SA</manufacturerName>
    <manufacturerSrn>BR-MF-000018793</manufacturerSrn>
    <authorisedRepresentativeName>EC Certification Service GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>AT-AR-000006658</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09.05.0662</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:14:25.287Z</lastUpdated>
  </row>
</eudamedExport>