<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>09555514008550</udiDi>
    <basicUdiDi>955551400LDDSH01JW</basicUdiDi>
    <tradeName>SanctuaryTM 5”X5” Latex Dental Dam-Green, Thin</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sanctuary Health Sdn Bhd</manufacturerName>
    <manufacturerSrn>MY-MF-000002197</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q019002</emdnCode>
    <emdnDescription>DENTISTRY DAMS AND HOOKS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DL511A-ECSH0</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T06:08:34.651Z</lastUpdated>
  </row>
  <row>
    <udiDi>09555514007669</udiDi>
    <basicUdiDi>955551400LDDSH01JW</basicUdiDi>
    <tradeName>SanctuaryTM 6”X6” Latex Dental Dam-Blue, Medium</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sanctuary Health Sdn Bhd</manufacturerName>
    <manufacturerSrn>MY-MF-000002197</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q019002</emdnCode>
    <emdnDescription>DENTISTRY DAMS AND HOOKS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DL622B-EBSH0</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T06:08:33.704Z</lastUpdated>
  </row>
  <row>
    <udiDi>09555514007652</udiDi>
    <basicUdiDi>955551400LDDSH01JW</basicUdiDi>
    <tradeName>SanctuaryTM 6”X6” Latex Dental Dam-Blue, Thin</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sanctuary Health Sdn Bhd</manufacturerName>
    <manufacturerSrn>MY-MF-000002197</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q019002</emdnCode>
    <emdnDescription>DENTISTRY DAMS AND HOOKS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DL612B-EBSH0</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T06:08:33.007Z</lastUpdated>
  </row>
  <row>
    <udiDi>09555514007539</udiDi>
    <basicUdiDi>955551400LDDSH01JW</basicUdiDi>
    <tradeName>SanctuaryTM 5”X5” Latex Dental Dam-Blue, Heavy</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sanctuary Health Sdn Bhd</manufacturerName>
    <manufacturerSrn>MY-MF-000002197</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q019002</emdnCode>
    <emdnDescription>DENTISTRY DAMS AND HOOKS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DL532B-ECSH0</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T06:08:32.516Z</lastUpdated>
  </row>
  <row>
    <udiDi>00840161302717</udiDi>
    <basicUdiDi>08401613000335</basicUdiDi>
    <tradeName>Insti-Dam® - Latex-Free Rubber Dam - Relaxed Fit - 20 Count</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zirc Dental Products Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000021065</manufacturerSrn>
    <authorisedRepresentativeName>Medicom GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005612</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q019002</emdnCode>
    <emdnDescription>DENTISTRY DAMS AND HOOKS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50Z457</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-24T23:29:50.640Z</lastUpdated>
  </row>
  <row>
    <udiDi>00840161304056</udiDi>
    <basicUdiDi>08401613000335</basicUdiDi>
    <tradeName>Insti-Dam® - Insti-Dam® Dispenser - White - 1 Count</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zirc Dental Products Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000021065</manufacturerSrn>
    <authorisedRepresentativeName>Medicom GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005612</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q019002</emdnCode>
    <emdnDescription>DENTISTRY DAMS AND HOOKS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50Z471</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-24T23:29:33.333Z</lastUpdated>
  </row>
  <row>
    <udiDi>00840161304780</udiDi>
    <basicUdiDi>08401613000335</basicUdiDi>
    <tradeName>Airway Armor® - Throat Guard - Variety Pack - 15 Count</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zirc Dental Products Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000021065</manufacturerSrn>
    <authorisedRepresentativeName>Medicom GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005612</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q019002</emdnCode>
    <emdnDescription>DENTISTRY DAMS AND HOOKS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50Z960TRI</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-24T23:29:15.037Z</lastUpdated>
  </row>
  <row>
    <udiDi>00840161304797</udiDi>
    <basicUdiDi>08401613000335</basicUdiDi>
    <tradeName>Airway Armor® - Throat Guard - Small - 25 Count</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zirc Dental Products Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000021065</manufacturerSrn>
    <authorisedRepresentativeName>Medicom GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005612</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q019002</emdnCode>
    <emdnDescription>DENTISTRY DAMS AND HOOKS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50Z960SM</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-24T23:29:15.011Z</lastUpdated>
  </row>
  <row>
    <udiDi>00840161304803</udiDi>
    <basicUdiDi>08401613000335</basicUdiDi>
    <tradeName>Airway Armor® - Throat Guard - Medium - 25 Count</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zirc Dental Products Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000021065</manufacturerSrn>
    <authorisedRepresentativeName>Medicom GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005612</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q019002</emdnCode>
    <emdnDescription>DENTISTRY DAMS AND HOOKS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50Z960MD</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-24T23:29:14.992Z</lastUpdated>
  </row>
  <row>
    <udiDi>00840161304810</udiDi>
    <basicUdiDi>08401613000335</basicUdiDi>
    <tradeName>Airway Armor® - Throat Guard - Large - 25 Count</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zirc Dental Products Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000021065</manufacturerSrn>
    <authorisedRepresentativeName>Medicom GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005612</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q019002</emdnCode>
    <emdnDescription>DENTISTRY DAMS AND HOOKS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50Z960LG</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-24T23:29:14.970Z</lastUpdated>
  </row>
  <row>
    <udiDi>00840161304827</udiDi>
    <basicUdiDi>08401613000335</basicUdiDi>
    <tradeName>Airway Armor® - Throat Guard - 3 Count Sample Pack</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zirc Dental Products Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000021065</manufacturerSrn>
    <authorisedRepresentativeName>Medicom GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005612</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q019002</emdnCode>
    <emdnDescription>DENTISTRY DAMS AND HOOKS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50Z960SMPL-INTL</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-24T23:29:14.953Z</lastUpdated>
  </row>
  <row>
    <udiDi>00840161307088</udiDi>
    <basicUdiDi>08401613000335</basicUdiDi>
    <tradeName>Airway Armor® - Throat Guard - Small - Sample</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zirc Dental Products Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000021065</manufacturerSrn>
    <authorisedRepresentativeName>Medicom GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005612</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q019002</emdnCode>
    <emdnDescription>DENTISTRY DAMS AND HOOKS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50Z960SMPL</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-24T23:29:10.252Z</lastUpdated>
  </row>
  <row>
    <udiDi>00840161311672</udiDi>
    <basicUdiDi>08401613000335</basicUdiDi>
    <tradeName>Insti-Dam® - Latex-Free Rubber Dam - Relaxed Fit - 1 Count Sample Pack</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zirc Dental Products Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000021065</manufacturerSrn>
    <authorisedRepresentativeName>Medicom GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005612</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q019002</emdnCode>
    <emdnDescription>DENTISTRY DAMS AND HOOKS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50Z457SMPL-INTL</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-24T23:28:47.640Z</lastUpdated>
  </row>
  <row>
    <udiDi>00840161311696</udiDi>
    <basicUdiDi>08401613000335</basicUdiDi>
    <tradeName>Insti-Dam® - Latex-Free Rubber Dam - 1 Count Sample Pack</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zirc Dental Products Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000021065</manufacturerSrn>
    <authorisedRepresentativeName>Medicom GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005612</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q019002</emdnCode>
    <emdnDescription>DENTISTRY DAMS AND HOOKS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50Z459SMPL-INTL</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-24T23:28:47.600Z</lastUpdated>
  </row>
  <row>
    <udiDi>00840161311894</udiDi>
    <basicUdiDi>08401613000335</basicUdiDi>
    <tradeName>Airway Armor® - Throat Guard - Large - 1 Count</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zirc Dental Products Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000021065</manufacturerSrn>
    <authorisedRepresentativeName>Medicom GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005612</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q019002</emdnCode>
    <emdnDescription>DENTISTRY DAMS AND HOOKS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5Z960LG</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-24T23:28:47.338Z</lastUpdated>
  </row>
  <row>
    <udiDi>00840161311900</udiDi>
    <basicUdiDi>08401613000335</basicUdiDi>
    <tradeName>Airway Armor® - Throat Guard - Medium - 1 Count</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zirc Dental Products Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000021065</manufacturerSrn>
    <authorisedRepresentativeName>Medicom GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005612</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q019002</emdnCode>
    <emdnDescription>DENTISTRY DAMS AND HOOKS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5Z960MD</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-24T23:28:47.305Z</lastUpdated>
  </row>
  <row>
    <udiDi>00840161311917</udiDi>
    <basicUdiDi>08401613000335</basicUdiDi>
    <tradeName>Airway Armor® - Throat Guard - Small - 1 Count</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zirc Dental Products Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000021065</manufacturerSrn>
    <authorisedRepresentativeName>Medicom GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005612</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q019002</emdnCode>
    <emdnDescription>DENTISTRY DAMS AND HOOKS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5Z960SM</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-24T23:28:47.276Z</lastUpdated>
  </row>
  <row>
    <udiDi>10732224002139</udiDi>
    <basicUdiDi>0732224DentalDamTX</basicUdiDi>
    <tradeName>Crosstex Dental Dams</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Crosstex International Inc</manufacturerName>
    <manufacturerSrn>US-MF-000009642</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q019002</emdnCode>
    <emdnDescription>DENTISTRY DAMS AND HOOKS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>19200</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T08:47:47.422Z</lastUpdated>
  </row>
  <row>
    <udiDi>10732224002146</udiDi>
    <basicUdiDi>0732224DentalDamTX</basicUdiDi>
    <tradeName>Crosstex Dental Dams</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Crosstex International Inc</manufacturerName>
    <manufacturerSrn>US-MF-000009642</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q019002</emdnCode>
    <emdnDescription>DENTISTRY DAMS AND HOOKS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>19201</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T08:47:47.366Z</lastUpdated>
  </row>
  <row>
    <udiDi>10732224002153</udiDi>
    <basicUdiDi>0732224DentalDamTX</basicUdiDi>
    <tradeName>Crosstex Dental Dams</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Crosstex International Inc</manufacturerName>
    <manufacturerSrn>US-MF-000009642</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q019002</emdnCode>
    <emdnDescription>DENTISTRY DAMS AND HOOKS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>19102</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T08:47:47.331Z</lastUpdated>
  </row>
</eudamedExport>