<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00385640001380</udiDi>
    <basicUdiDi>B-00385640001380</basicUdiDi>
    <tradeName>Baxter Bevel Button, FP, 1.27 mm</tradeName>
    <deviceName>Otological Ventilation Tubes</deviceName>
    <manufacturerName>Summit Medical, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000026771</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q03040199</emdnCode>
    <emdnDescription>EAR DRAINAGE AND VENTILATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VT-0602-01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T06:56:51.349Z</lastUpdated>
  </row>
  <row>
    <udiDi>00385640001342</udiDi>
    <basicUdiDi>B-00385640001342</basicUdiDi>
    <tradeName>Modified Armstrong Grommet, FP, 1.14 mm</tradeName>
    <deviceName>Otological Ventilation Tubes</deviceName>
    <manufacturerName>Summit Medical, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000026771</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q03040199</emdnCode>
    <emdnDescription>EAR DRAINAGE AND VENTILATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VT-0508-01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T06:56:50.565Z</lastUpdated>
  </row>
  <row>
    <udiDi>00385640001304</udiDi>
    <basicUdiDi>B-00385640001304</basicUdiDi>
    <tradeName>Armstrong Grommet, FP, 1.14 mm</tradeName>
    <deviceName>Otological Ventilation Tubes</deviceName>
    <manufacturerName>Summit Medical, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000026771</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q03040199</emdnCode>
    <emdnDescription>EAR DRAINAGE AND VENTILATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VT-0503-01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T06:56:45.738Z</lastUpdated>
  </row>
  <row>
    <udiDi>00385640001267</udiDi>
    <basicUdiDi>B-00385640001267</basicUdiDi>
    <tradeName>Armstrong Beveled Straight Shank, FP, 1.14 mm</tradeName>
    <deviceName>Otological Ventilation Tubes</deviceName>
    <manufacturerName>Summit Medical, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000026771</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q03040199</emdnCode>
    <emdnDescription>EAR DRAINAGE AND VENTILATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VT-0501-01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T06:56:44.942Z</lastUpdated>
  </row>
  <row>
    <udiDi>00385640001243</udiDi>
    <basicUdiDi>B-00385640001243</basicUdiDi>
    <tradeName>Armstrong Beveled Straight Shank, SI, 1.14 mm</tradeName>
    <deviceName>Otological Ventilation Tubes</deviceName>
    <manufacturerName>Summit Medical, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000026771</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q03040199</emdnCode>
    <emdnDescription>EAR DRAINAGE AND VENTILATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VT-0500-01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T06:56:44.146Z</lastUpdated>
  </row>
  <row>
    <udiDi>00385640001229</udiDi>
    <basicUdiDi>B-00385640001229</basicUdiDi>
    <tradeName>8.0mm x 9.8mm SuperSoft™ T-Tube, SI, 1.14 mm</tradeName>
    <deviceName>Otological Ventilation Tubes</deviceName>
    <manufacturerName>Summit Medical, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000026771</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q03040199</emdnCode>
    <emdnDescription>EAR DRAINAGE AND VENTILATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VT-0410-01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T06:56:43.342Z</lastUpdated>
  </row>
  <row>
    <udiDi>00385640001205</udiDi>
    <basicUdiDi>B-00385640001205</basicUdiDi>
    <tradeName>12mm x 9.8mm SuperSoft™ T-Tube, SI, 1.14 mm</tradeName>
    <deviceName>Otological Ventilation Tubes</deviceName>
    <manufacturerName>Summit Medical, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000026771</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q03040199</emdnCode>
    <emdnDescription>EAR DRAINAGE AND VENTILATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VT-0409-01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T06:56:39.356Z</lastUpdated>
  </row>
  <row>
    <udiDi>00385640001182</udiDi>
    <basicUdiDi>B-00385640001182</basicUdiDi>
    <tradeName>Touma II T-Tube, SI, 1.12 mm</tradeName>
    <deviceName>Otological Ventilation Tubes</deviceName>
    <manufacturerName>Summit Medical, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000026771</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q03040199</emdnCode>
    <emdnDescription>EAR DRAINAGE AND VENTILATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VT-0408-01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T06:56:38.556Z</lastUpdated>
  </row>
  <row>
    <udiDi>00385640001168</udiDi>
    <basicUdiDi>B-00385640001168</basicUdiDi>
    <tradeName>8.0mm x 5.6mm T-Tube, SI, 1.14 mm</tradeName>
    <deviceName>Otological Ventilation Tubes</deviceName>
    <manufacturerName>Summit Medical, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000026771</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q03040199</emdnCode>
    <emdnDescription>EAR DRAINAGE AND VENTILATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VT-0407-01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T06:56:37.742Z</lastUpdated>
  </row>
  <row>
    <udiDi>00385640001144</udiDi>
    <basicUdiDi>B-00385640001144</basicUdiDi>
    <tradeName>4.8mm x 4.1mm T-Tube, SI, 1.14mm</tradeName>
    <deviceName>Otological Ventilation Tubes</deviceName>
    <manufacturerName>Summit Medical, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000026771</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q03040199</emdnCode>
    <emdnDescription>EAR DRAINAGE AND VENTILATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VT-0406-01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T06:56:36.940Z</lastUpdated>
  </row>
  <row>
    <udiDi>00385640001120</udiDi>
    <basicUdiDi>B-00385640001120</basicUdiDi>
    <tradeName>Touma T-Tube, SI, 1.14 mm</tradeName>
    <deviceName>Otological Ventilation Tubes</deviceName>
    <manufacturerName>Summit Medical, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000026771</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q03040199</emdnCode>
    <emdnDescription>EAR DRAINAGE AND VENTILATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VT-0405-01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T06:56:32.130Z</lastUpdated>
  </row>
  <row>
    <udiDi>00385640001106</udiDi>
    <basicUdiDi>B-00385640001106</basicUdiDi>
    <tradeName>T-Tube Grommet, SI, 1.27 mm</tradeName>
    <deviceName>Otological Ventilation Tubes</deviceName>
    <manufacturerName>Summit Medical, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000026771</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q03040199</emdnCode>
    <emdnDescription>EAR DRAINAGE AND VENTILATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VT-0403-01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T06:56:31.331Z</lastUpdated>
  </row>
  <row>
    <udiDi>00385640001083</udiDi>
    <basicUdiDi>B-00385640001083</basicUdiDi>
    <tradeName>4.8mm x 7.9mm T-Tube, SI, 1.14 mm</tradeName>
    <deviceName>Otological Ventilation Tubes</deviceName>
    <manufacturerName>Summit Medical, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000026771</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q03040199</emdnCode>
    <emdnDescription>EAR DRAINAGE AND VENTILATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VT-0401-01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T06:56:30.530Z</lastUpdated>
  </row>
  <row>
    <udiDi>00385640001069</udiDi>
    <basicUdiDi>B-00385640001069</basicUdiDi>
    <tradeName>12mm x 9.8mm T-Tube, SI, 1.14 mm</tradeName>
    <deviceName>Otological Ventilation Tubes</deviceName>
    <manufacturerName>Summit Medical, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000026771</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q03040199</emdnCode>
    <emdnDescription>EAR DRAINAGE AND VENTILATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VT-0400-01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T06:56:29.759Z</lastUpdated>
  </row>
  <row>
    <udiDi>00385640001038</udiDi>
    <basicUdiDi>B-00385640001038</basicUdiDi>
    <tradeName>Parapella II, SI, 1.42 mm</tradeName>
    <deviceName>Otological Ventilation Tubes</deviceName>
    <manufacturerName>Summit Medical, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000026771</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q03040199</emdnCode>
    <emdnDescription>EAR DRAINAGE AND VENTILATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VT-0301-01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T06:56:25.721Z</lastUpdated>
  </row>
  <row>
    <udiDi>00385640000994</udiDi>
    <basicUdiDi>B-00385640000994</basicUdiDi>
    <tradeName>Parapella I, SI, 1.14 mm</tradeName>
    <deviceName>Otological Ventilation Tubes</deviceName>
    <manufacturerName>Summit Medical, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000026771</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q03040199</emdnCode>
    <emdnDescription>EAR DRAINAGE AND VENTILATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VT-0300-01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T06:56:24.921Z</lastUpdated>
  </row>
  <row>
    <udiDi>00385640000901</udiDi>
    <basicUdiDi>B-00385640000901</basicUdiDi>
    <tradeName>Shepard, FP, 1.00 mm</tradeName>
    <deviceName>Otological Ventilation Tubes</deviceName>
    <manufacturerName>Summit Medical, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000026771</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q03040199</emdnCode>
    <emdnDescription>EAR DRAINAGE AND VENTILATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VT-0204-01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T06:56:24.154Z</lastUpdated>
  </row>
  <row>
    <udiDi>00385640000895</udiDi>
    <basicUdiDi>B-00385640000895</basicUdiDi>
    <tradeName>Shepard, FP, 1.00 mm</tradeName>
    <deviceName>Otological Ventilation Tubes</deviceName>
    <manufacturerName>Summit Medical, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000026771</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q03040199</emdnCode>
    <emdnDescription>EAR DRAINAGE AND VENTILATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VT-0203-01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T06:56:23.331Z</lastUpdated>
  </row>
  <row>
    <udiDi>00385640000628</udiDi>
    <basicUdiDi>B-00385640000628</basicUdiDi>
    <tradeName>Shepard, FP, 1.14 mm</tradeName>
    <deviceName>Otological Ventilation Tubes</deviceName>
    <manufacturerName>Summit Medical, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000026771</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q03040199</emdnCode>
    <emdnDescription>EAR DRAINAGE AND VENTILATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VT-0202-01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T06:56:18.516Z</lastUpdated>
  </row>
  <row>
    <udiDi>00385640000604</udiDi>
    <basicUdiDi>B-00385640000604</basicUdiDi>
    <tradeName>Shepard, FP, 1.14 mm</tradeName>
    <deviceName>Otological Ventilation Tubes</deviceName>
    <manufacturerName>Summit Medical, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000026771</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q03040199</emdnCode>
    <emdnDescription>EAR DRAINAGE AND VENTILATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VT-0201-01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T06:56:17.717Z</lastUpdated>
  </row>
</eudamedExport>