<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08434048485826</udiDi>
    <basicUdiDi>843404825APNEAAA</basicUdiDi>
    <tradeName>Set Monitorización Brizzy+10 SCR</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PRIM, S.A.</manufacturerName>
    <manufacturerSrn>ES-PR-000004648</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12080406</emdnCode>
    <emdnDescription>APNOEA MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NS010SCR</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T02:52:11.418Z</lastUpdated>
  </row>
  <row>
    <udiDi>08434048500949</udiDi>
    <basicUdiDi>843404825KITFRESADOORLKY</basicUdiDi>
    <tradeName>SET CENS RECTA SERRADA 3,5 MM</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PRIM, S.A.</manufacturerName>
    <manufacturerSrn>ES-PR-000004648</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q030302</emdnCode>
    <emdnDescription>ENT SURGERY BURS AND HANDPIECES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BA539</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T02:52:11.295Z</lastUpdated>
  </row>
  <row>
    <udiDi>08434048500987</udiDi>
    <basicUdiDi>843404825KITFRESADOORLKY</basicUdiDi>
    <tradeName>SET CENS RECTA SERRADA 4 MM</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PRIM, S.A.</manufacturerName>
    <manufacturerSrn>ES-PR-000004648</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q030302</emdnCode>
    <emdnDescription>ENT SURGERY BURS AND HANDPIECES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BA540</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T02:52:11.279Z</lastUpdated>
  </row>
  <row>
    <udiDi>08434048500994</udiDi>
    <basicUdiDi>843404825KITFRESADOORLKY</basicUdiDi>
    <tradeName>SET CENS 15º CONCAVA SERRADA DOBLE 4 MM</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PRIM, S.A.</manufacturerName>
    <manufacturerSrn>ES-PR-000004648</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q030302</emdnCode>
    <emdnDescription>ENT SURGERY BURS AND HANDPIECES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BA570</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T02:52:11.261Z</lastUpdated>
  </row>
  <row>
    <udiDi>08434048501007</udiDi>
    <basicUdiDi>843404825KITFRESADOORLKY</basicUdiDi>
    <tradeName>SET DCR SHAVER DIAMANTE CONCAVA 3 MM</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PRIM, S.A.</manufacturerName>
    <manufacturerSrn>ES-PR-000004648</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q030302</emdnCode>
    <emdnDescription>ENT SURGERY BURS AND HANDPIECES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BA650</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T02:52:11.244Z</lastUpdated>
  </row>
  <row>
    <udiDi>08434048501014</udiDi>
    <basicUdiDi>843404825ASPIRACIONORLDH</basicUdiDi>
    <tradeName>Set  Aspiración 70 mm con adaptador N</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PRIM, S.A.</manufacturerName>
    <manufacturerSrn>ES-PR-000004648</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A01020102</emdnCode>
    <emdnDescription>ASPIRATION FINE NEEDLES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EISET_01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T02:52:11.234Z</lastUpdated>
  </row>
  <row>
    <udiDi>08434048501021</udiDi>
    <basicUdiDi>843404825KITFRESADOORLKY</basicUdiDi>
    <tradeName>SET FRESA D_CARBURO 2.3 x 70 MM</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PRIM, S.A.</manufacturerName>
    <manufacturerSrn>ES-PR-000004648</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q030302</emdnCode>
    <emdnDescription>ENT SURGERY BURS AND HANDPIECES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BAC_070.23</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T02:52:11.225Z</lastUpdated>
  </row>
  <row>
    <udiDi>08434048504749</udiDi>
    <basicUdiDi>843404825APNEAAA</basicUdiDi>
    <tradeName>Set Monitorización Brizzy NJ Pk10</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PRIM, S.A.</manufacturerName>
    <manufacturerSrn>ES-PR-000004648</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12080406</emdnCode>
    <emdnDescription>APNOEA MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NS010NJ</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T02:52:11.213Z</lastUpdated>
  </row>
  <row>
    <udiDi>08434048511419</udiDi>
    <basicUdiDi>843404825APNEAAA</basicUdiDi>
    <tradeName>Kit Inicio Avance Mandibular</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PRIM, S.A.</manufacturerName>
    <manufacturerSrn>ES-PR-000004648</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12080406</emdnCode>
    <emdnDescription>APNOEA MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AG25-1009</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T02:52:11.081Z</lastUpdated>
  </row>
  <row>
    <udiDi>08434048530304</udiDi>
    <basicUdiDi>843404825KITLAPAROSIIBKB</basicUdiDi>
    <tradeName>Kit Obesidad + Hiato</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PRIM, S.A.</manufacturerName>
    <manufacturerSrn>ES-PR-000004648</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>K0201011102</emdnCode>
    <emdnDescription>LAPAROSCOPIC AND THORACOSCOPIC ELECTROSURGERY INSTRUMENT KITS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LAP-002X</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T02:52:10.810Z</lastUpdated>
  </row>
  <row>
    <udiDi>08434048530700</udiDi>
    <basicUdiDi>843404825SURGORL3P</basicUdiDi>
    <tradeName>SET MIRINGO DONALDSON SILICONA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PRIM, S.A.</manufacturerName>
    <manufacturerSrn>ES-PR-000004648</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P02010201</emdnCode>
    <emdnDescription>TRANSTYMPANIC DRAINAGE PROSTHESES (VENTILATION TUBES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SET3111</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T02:52:10.794Z</lastUpdated>
  </row>
  <row>
    <udiDi>08434048530717</udiDi>
    <basicUdiDi>843404825SURGORL3P</basicUdiDi>
    <tradeName>SET MIRINGO SHEPARD PEDIATRICO</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PRIM, S.A.</manufacturerName>
    <manufacturerSrn>ES-PR-000004648</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P02010201</emdnCode>
    <emdnDescription>TRANSTYMPANIC DRAINAGE PROSTHESES (VENTILATION TUBES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SET2138</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T02:52:10.785Z</lastUpdated>
  </row>
  <row>
    <udiDi>08434048535088</udiDi>
    <basicUdiDi>843404825APNEAAA</basicUdiDi>
    <tradeName>Set Inicio Apneaguard S/C</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PRIM, S.A.</manufacturerName>
    <manufacturerSrn>ES-PR-000004648</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12080406</emdnCode>
    <emdnDescription>APNOEA MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>25-100X</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T02:52:10.735Z</lastUpdated>
  </row>
  <row>
    <udiDi>08434048544059</udiDi>
    <basicUdiDi>843404825KITFRESADOORLKY</basicUdiDi>
    <tradeName>SET FRESA DIAMANTE 1.8 x 70 MM</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PRIM, S.A.</manufacturerName>
    <manufacturerSrn>ES-PR-000004648</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q030302</emdnCode>
    <emdnDescription>ENT SURGERY BURS AND HANDPIECES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BAD070_18</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T02:52:10.560Z</lastUpdated>
  </row>
  <row>
    <udiDi>08434048544066</udiDi>
    <basicUdiDi>843404825KITFRESADOORLKY</basicUdiDi>
    <tradeName>Set Fresa Diamante 2.3 x 70 MM</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PRIM, S.A.</manufacturerName>
    <manufacturerSrn>ES-PR-000004648</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q030302</emdnCode>
    <emdnDescription>ENT SURGERY BURS AND HANDPIECES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BAD070_23</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T02:52:10.549Z</lastUpdated>
  </row>
  <row>
    <udiDi>08434048544073</udiDi>
    <basicUdiDi>843404825KITFRESADOORLKY</basicUdiDi>
    <tradeName>Set Fresa Diamante 2.7 x 70 MM</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PRIM, S.A.</manufacturerName>
    <manufacturerSrn>ES-PR-000004648</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q030302</emdnCode>
    <emdnDescription>ENT SURGERY BURS AND HANDPIECES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BAD070_27</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T02:52:10.532Z</lastUpdated>
  </row>
  <row>
    <udiDi>08434048544080</udiDi>
    <basicUdiDi>843404825KITFRESADOORLKY</basicUdiDi>
    <tradeName>Set Fresa Diamante 3.1 x 70 MM</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PRIM, S.A.</manufacturerName>
    <manufacturerSrn>ES-PR-000004648</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q030302</emdnCode>
    <emdnDescription>ENT SURGERY BURS AND HANDPIECES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BAD070_31</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T02:52:10.518Z</lastUpdated>
  </row>
  <row>
    <udiDi>08434048544097</udiDi>
    <basicUdiDi>843404825KITFRESADOORLKY</basicUdiDi>
    <tradeName>Set Fresa Diamante 3.5 x 70 MM</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PRIM, S.A.</manufacturerName>
    <manufacturerSrn>ES-PR-000004648</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q030302</emdnCode>
    <emdnDescription>ENT SURGERY BURS AND HANDPIECES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BAD070_35</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T02:52:10.508Z</lastUpdated>
  </row>
  <row>
    <udiDi>08434048544103</udiDi>
    <basicUdiDi>843404825KITFRESADOORLKY</basicUdiDi>
    <tradeName>Set Fresa Diamante 4.0 x 70 MM</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PRIM, S.A.</manufacturerName>
    <manufacturerSrn>ES-PR-000004648</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q030302</emdnCode>
    <emdnDescription>ENT SURGERY BURS AND HANDPIECES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BAD070_40</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T02:52:10.493Z</lastUpdated>
  </row>
  <row>
    <udiDi>08434048544110</udiDi>
    <basicUdiDi>843404825KITFRESADOORLKY</basicUdiDi>
    <tradeName>Set Fresa Diamante 4.5 x 70 MM</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PRIM, S.A.</manufacturerName>
    <manufacturerSrn>ES-PR-000004648</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q030302</emdnCode>
    <emdnDescription>ENT SURGERY BURS AND HANDPIECES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BAD070_45</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T02:52:10.480Z</lastUpdated>
  </row>
</eudamedExport>