<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00810032660178</udiDi>
    <basicUdiDi>B-00810032660178</basicUdiDi>
    <tradeName>Posterior Mouthpiece</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zyris, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000034843</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q019001</emdnCode>
    <emdnDescription>SALIVA ASPIRATORS AND SALIVA ABSORBENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CIL0801</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:52:42.073Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810032660086</udiDi>
    <basicUdiDi>B-00810032660086</basicUdiDi>
    <tradeName>Posterior Mouthpiece</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zyris, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000034843</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q019001</emdnCode>
    <emdnDescription>SALIVA ASPIRATORS AND SALIVA ABSORBENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CIL0501</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:52:38.073Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810032660147</udiDi>
    <basicUdiDi>B-00810032660147</basicUdiDi>
    <tradeName>Posterior Mouthpiece</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zyris, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000034843</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q019001</emdnCode>
    <emdnDescription>SALIVA ASPIRATORS AND SALIVA ABSORBENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CIL0701</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:52:37.251Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810032660116</udiDi>
    <basicUdiDi>B-00810032660116</basicUdiDi>
    <tradeName>Posterior Mouthpiece</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zyris, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000034843</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q019001</emdnCode>
    <emdnDescription>SALIVA ASPIRATORS AND SALIVA ABSORBENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CIL0601</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:52:36.597Z</lastUpdated>
  </row>
  <row>
    <udiDi>00304040091579</udiDi>
    <basicUdiDi>B-00304040091579</basicUdiDi>
    <tradeName>Henry Schein</tradeName>
    <deviceName>Surgical Tips</deviceName>
    <manufacturerName>Henry Schein Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000021683</manufacturerSrn>
    <authorisedRepresentativeName>Henry Schein Services GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000008001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q019001</emdnCode>
    <emdnDescription>SALIVA ASPIRATORS AND SALIVA ABSORBENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9006996</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T13:09:19.521Z</lastUpdated>
  </row>
  <row>
    <udiDi>+D838336PASS4</udiDi>
    <basicUdiDi>B-+D838336PASS4</basicUdiDi>
    <tradeName>HVE suction tubes</tradeName>
    <deviceName>Dental Suction Tips</deviceName>
    <manufacturerName>Premium Plus International Limited</manufacturerName>
    <manufacturerSrn>HK-MF-000039905</manufacturerSrn>
    <authorisedRepresentativeName>Premium Plus Poland sp. z o.o.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PL-AR-000030110</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q019001</emdnCode>
    <emdnDescription>SALIVA ASPIRATORS AND SALIVA ABSORBENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>336PASS</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T04:34:09.305Z</lastUpdated>
  </row>
  <row>
    <udiDi>+D838335MASS4</udiDi>
    <basicUdiDi>B-+D838335MASS4</basicUdiDi>
    <tradeName>HVE suction tubes</tradeName>
    <deviceName>Dental Suction Tips</deviceName>
    <manufacturerName>Premium Plus International Limited</manufacturerName>
    <manufacturerSrn>HK-MF-000039905</manufacturerSrn>
    <authorisedRepresentativeName>Premium Plus Poland sp. z o.o.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PL-AR-000030110</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q019001</emdnCode>
    <emdnDescription>SALIVA ASPIRATORS AND SALIVA ABSORBENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>335MASS</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T04:34:08.509Z</lastUpdated>
  </row>
  <row>
    <udiDi>+D838335LASS4</udiDi>
    <basicUdiDi>B-+D838335LASS4</basicUdiDi>
    <tradeName>HVE suction tubes</tradeName>
    <deviceName>Dental Suction Tips</deviceName>
    <manufacturerName>Premium Plus International Limited</manufacturerName>
    <manufacturerSrn>HK-MF-000039905</manufacturerSrn>
    <authorisedRepresentativeName>Premium Plus Poland sp. z o.o.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PL-AR-000030110</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q019001</emdnCode>
    <emdnDescription>SALIVA ASPIRATORS AND SALIVA ABSORBENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>335LASS</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T04:34:04.505Z</lastUpdated>
  </row>
  <row>
    <udiDi>+D838308YELLOW4</udiDi>
    <basicUdiDi>B-+D838308YELLOW4</basicUdiDi>
    <tradeName>Disposable Oral Evacuators Vented S Cut</tradeName>
    <deviceName>Dental Suction Tips</deviceName>
    <manufacturerName>Premium Plus International Limited</manufacturerName>
    <manufacturerSrn>HK-MF-000039905</manufacturerSrn>
    <authorisedRepresentativeName>Premium Plus Poland sp. z o.o.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PL-AR-000030110</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q019001</emdnCode>
    <emdnDescription>SALIVA ASPIRATORS AND SALIVA ABSORBENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>308YELLOW</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T04:34:03.818Z</lastUpdated>
  </row>
  <row>
    <udiDi>+D838308LIME4</udiDi>
    <basicUdiDi>B-+D838308LIME4</basicUdiDi>
    <tradeName>Disposable Oral Evacuators Vented S Cut</tradeName>
    <deviceName>Dental Suction Tips</deviceName>
    <manufacturerName>Premium Plus International Limited</manufacturerName>
    <manufacturerSrn>HK-MF-000039905</manufacturerSrn>
    <authorisedRepresentativeName>Premium Plus Poland sp. z o.o.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PL-AR-000030110</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q019001</emdnCode>
    <emdnDescription>SALIVA ASPIRATORS AND SALIVA ABSORBENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>308LIME</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T04:33:48.447Z</lastUpdated>
  </row>
  <row>
    <udiDi>+D838308LBLUE4</udiDi>
    <basicUdiDi>B-+D838308LBLUE4</basicUdiDi>
    <tradeName>Disposable Oral Evacuators Vented S Cut</tradeName>
    <deviceName>Dental Suction Tips</deviceName>
    <manufacturerName>Premium Plus International Limited</manufacturerName>
    <manufacturerSrn>HK-MF-000039905</manufacturerSrn>
    <authorisedRepresentativeName>Premium Plus Poland sp. z o.o.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PL-AR-000030110</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q019001</emdnCode>
    <emdnDescription>SALIVA ASPIRATORS AND SALIVA ABSORBENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>308LBLUE</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T04:33:47.625Z</lastUpdated>
  </row>
  <row>
    <udiDi>+D838308GREEN4</udiDi>
    <basicUdiDi>B-+D838308GREEN4</basicUdiDi>
    <tradeName>Disposable Oral Evacuators Vented S Cut</tradeName>
    <deviceName>Dental Suction Tips</deviceName>
    <manufacturerName>Premium Plus International Limited</manufacturerName>
    <manufacturerSrn>HK-MF-000039905</manufacturerSrn>
    <authorisedRepresentativeName>Premium Plus Poland sp. z o.o.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PL-AR-000030110</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q019001</emdnCode>
    <emdnDescription>SALIVA ASPIRATORS AND SALIVA ABSORBENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>308GREEN</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T04:33:46.835Z</lastUpdated>
  </row>
  <row>
    <udiDi>+D838308ASS2</udiDi>
    <basicUdiDi>B-+D838308ASS2</basicUdiDi>
    <tradeName>Disposable Oral Evacuators Vented S Cut</tradeName>
    <deviceName>Dental Suction Tips</deviceName>
    <manufacturerName>Premium Plus International Limited</manufacturerName>
    <manufacturerSrn>HK-MF-000039905</manufacturerSrn>
    <authorisedRepresentativeName>Premium Plus Poland sp. z o.o.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PL-AR-000030110</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q019001</emdnCode>
    <emdnDescription>SALIVA ASPIRATORS AND SALIVA ABSORBENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>308ASS</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T04:33:46.033Z</lastUpdated>
  </row>
  <row>
    <udiDi>+D8383081LAV4</udiDi>
    <basicUdiDi>B-+D8383081LAV4</basicUdiDi>
    <tradeName>Disposable Oral Evacuators Vented S Cut</tradeName>
    <deviceName>Dental Suction Tips</deviceName>
    <manufacturerName>Premium Plus International Limited</manufacturerName>
    <manufacturerSrn>HK-MF-000039905</manufacturerSrn>
    <authorisedRepresentativeName>Premium Plus Poland sp. z o.o.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PL-AR-000030110</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q019001</emdnCode>
    <emdnDescription>SALIVA ASPIRATORS AND SALIVA ABSORBENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>308LAV</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T04:33:41.218Z</lastUpdated>
  </row>
  <row>
    <udiDi>+D838301YELLOW4</udiDi>
    <basicUdiDi>B-+D838301YELLOW4</basicUdiDi>
    <tradeName>Disposable Oral Evacuators Vented/Non-vented S Cut</tradeName>
    <deviceName>Dental Suction Tips</deviceName>
    <manufacturerName>Premium Plus International Limited</manufacturerName>
    <manufacturerSrn>HK-MF-000039905</manufacturerSrn>
    <authorisedRepresentativeName>Premium Plus Poland sp. z o.o.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PL-AR-000030110</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q019001</emdnCode>
    <emdnDescription>SALIVA ASPIRATORS AND SALIVA ABSORBENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>301YELLOW</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T04:33:40.437Z</lastUpdated>
  </row>
  <row>
    <udiDi>+D838301LIME4</udiDi>
    <basicUdiDi>B-+D838301LIME4</basicUdiDi>
    <tradeName>Disposable Oral Evacuators Vented/Non-vented S Cut</tradeName>
    <deviceName>Dental Suction Tips</deviceName>
    <manufacturerName>Premium Plus International Limited</manufacturerName>
    <manufacturerSrn>HK-MF-000039905</manufacturerSrn>
    <authorisedRepresentativeName>Premium Plus Poland sp. z o.o.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PL-AR-000030110</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q019001</emdnCode>
    <emdnDescription>SALIVA ASPIRATORS AND SALIVA ABSORBENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>301LIME</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T04:33:39.616Z</lastUpdated>
  </row>
  <row>
    <udiDi>+D838301LBLUE4</udiDi>
    <basicUdiDi>B-+D838301LBLUE4</basicUdiDi>
    <tradeName>Disposable Oral Evacuators Vented/Non-vented S Cut</tradeName>
    <deviceName>Disposable Oral Evacuators Vented/Non-vented S Cut</deviceName>
    <manufacturerName>Premium Plus International Limited</manufacturerName>
    <manufacturerSrn>HK-MF-000039905</manufacturerSrn>
    <authorisedRepresentativeName>Premium Plus Poland sp. z o.o.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PL-AR-000030110</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q019001</emdnCode>
    <emdnDescription>SALIVA ASPIRATORS AND SALIVA ABSORBENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>301LBLUE</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T04:33:38.819Z</lastUpdated>
  </row>
  <row>
    <udiDi>+D838301LAV4</udiDi>
    <basicUdiDi>B-+D838301LAV4</basicUdiDi>
    <tradeName>Disposable Oral Evacuators Vented/Non-vented S Cut</tradeName>
    <deviceName>Dental Suction Tips</deviceName>
    <manufacturerName>Premium Plus International Limited</manufacturerName>
    <manufacturerSrn>HK-MF-000039905</manufacturerSrn>
    <authorisedRepresentativeName>Premium Plus Poland sp. z o.o.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PL-AR-000030110</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q019001</emdnCode>
    <emdnDescription>SALIVA ASPIRATORS AND SALIVA ABSORBENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>301LAV</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T04:33:34.813Z</lastUpdated>
  </row>
  <row>
    <udiDi>+D838301GREEN4</udiDi>
    <basicUdiDi>B-+D838301GREEN4</basicUdiDi>
    <tradeName>Disposable Oral Evacuators Vented/Non-vented S Cut</tradeName>
    <deviceName>Dental Suction Tips</deviceName>
    <manufacturerName>Premium Plus International Limited</manufacturerName>
    <manufacturerSrn>HK-MF-000039905</manufacturerSrn>
    <authorisedRepresentativeName>Premium Plus Poland sp. z o.o.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PL-AR-000030110</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q019001</emdnCode>
    <emdnDescription>SALIVA ASPIRATORS AND SALIVA ABSORBENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>301GREEN</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T04:33:34.015Z</lastUpdated>
  </row>
  <row>
    <udiDi>+D838301ASS2</udiDi>
    <basicUdiDi>B-+D838301ASS2</basicUdiDi>
    <tradeName>Disposable Oral Evacuators Vented/Non-vented S Cut</tradeName>
    <deviceName>Dental Suction Tips</deviceName>
    <manufacturerName>Premium Plus International Limited</manufacturerName>
    <manufacturerSrn>HK-MF-000039905</manufacturerSrn>
    <authorisedRepresentativeName>Premium Plus Poland sp. z o.o.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PL-AR-000030110</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q019001</emdnCode>
    <emdnDescription>SALIVA ASPIRATORS AND SALIVA ABSORBENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>301ASS</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T04:33:33.214Z</lastUpdated>
  </row>
</eudamedExport>