<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06951233721887</udiDi>
    <basicUdiDi>B-06951233721887</basicUdiDi>
    <tradeName>palaJet ® AC Power Adapter UK</tradeName>
    <deviceName>Accessory: AC Power Supply for Disposable Electronically Pulsed Lavage Suction Apparatus (AC Power Adapter UK)</deviceName>
    <manufacturerName>Guangzhou Clean Medical Products Manufacturing Corp.</manufacturerName>
    <manufacturerSrn>CN-MF-000008926</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A03040299</emdnCode>
    <emdnDescription>IRRIGATION KITS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5206240</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-06T03:59:31.334Z</lastUpdated>
  </row>
  <row>
    <udiDi>06951233720873</udiDi>
    <basicUdiDi>B-06951233720873</basicUdiDi>
    <tradeName>ic-lavage set with nozzles and splash shield</tradeName>
    <deviceName>Disposable Electronically Pulsed Lavage Suction Apparatus</deviceName>
    <manufacturerName>Guangzhou Clean Medical Products Manufacturing Corp.</manufacturerName>
    <manufacturerSrn>CN-MF-000008926</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A03040299</emdnCode>
    <emdnDescription>IRRIGATION KITS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>00678001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-05T22:02:57.280Z</lastUpdated>
  </row>
  <row>
    <udiDi>06951233721849</udiDi>
    <basicUdiDi>B-06951233721849</basicUdiDi>
    <tradeName>palaJet ® AC Power Adapter</tradeName>
    <deviceName>Accessory: AC Power Supply for Disposable Electronically Pulsed Lavage Suction Apparatus (AC Power Adapter)</deviceName>
    <manufacturerName>Guangzhou Clean Medical Products Manufacturing Corp.</manufacturerName>
    <manufacturerSrn>CN-MF-000008926</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A03040299</emdnCode>
    <emdnDescription>IRRIGATION KITS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5203576</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-05T11:37:26.642Z</lastUpdated>
  </row>
  <row>
    <udiDi>06951233721832</udiDi>
    <basicUdiDi>B-06951233721832</basicUdiDi>
    <tradeName>palaJet® Femoral Nozzle</tradeName>
    <deviceName>Accessory: Femoral Nozzle (Long Nozzle)</deviceName>
    <manufacturerName>Guangzhou Clean Medical Products Manufacturing Corp.</manufacturerName>
    <manufacturerSrn>CN-MF-000008926</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A03040299</emdnCode>
    <emdnDescription>IRRIGATION KITS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5202878</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-05T11:37:25.854Z</lastUpdated>
  </row>
  <row>
    <udiDi>06951233721825</udiDi>
    <basicUdiDi>B-06951233721825</basicUdiDi>
    <tradeName>palaJet®Fan Spray Nozzle / Knee</tradeName>
    <deviceName>Accessory: Fan Spray Nozzle (Short Nozzle)</deviceName>
    <manufacturerName>Guangzhou Clean Medical Products Manufacturing Corp.</manufacturerName>
    <manufacturerSrn>CN-MF-000008926</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A03040299</emdnCode>
    <emdnDescription>IRRIGATION KITS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5202875</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-05T11:37:21.863Z</lastUpdated>
  </row>
  <row>
    <udiDi>06951233720965</udiDi>
    <basicUdiDi>B-06951233720965</basicUdiDi>
    <tradeName>PulsaClean® AC Power Adapter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Guangzhou Clean Medical Products Manufacturing Corp.</manufacturerName>
    <manufacturerSrn>CN-MF-000008926</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A03040299</emdnCode>
    <emdnDescription>IRRIGATION KITS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LD 1510</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-05T11:37:21.024Z</lastUpdated>
  </row>
  <row>
    <udiDi>06951233720941</udiDi>
    <basicUdiDi>B-06951233720941</basicUdiDi>
    <tradeName>palaJet® Large Splash Shield</tradeName>
    <deviceName>Accessory: Large Splash Shield</deviceName>
    <manufacturerName>Guangzhou Clean Medical Products Manufacturing Corp.</manufacturerName>
    <manufacturerSrn>CN-MF-000008926</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A03040299</emdnCode>
    <emdnDescription>IRRIGATION KITS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5167809</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-05T11:37:20.242Z</lastUpdated>
  </row>
  <row>
    <udiDi>06951233720934</udiDi>
    <basicUdiDi>B-06951233720934</basicUdiDi>
    <tradeName>palaJet® Shower Spray Nozzle</tradeName>
    <deviceName>Accessory: Shower Spray Nozzle (Short Nozzle)</deviceName>
    <manufacturerName>Guangzhou Clean Medical Products Manufacturing Corp.</manufacturerName>
    <manufacturerSrn>CN-MF-000008926</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A03040299</emdnCode>
    <emdnDescription>IRRIGATION KITS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5167808</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-05T11:37:19.442Z</lastUpdated>
  </row>
  <row>
    <udiDi>06951233720927</udiDi>
    <basicUdiDi>B-06951233720927</basicUdiDi>
    <tradeName>palaJet® Femoral Brush Nozzle</tradeName>
    <deviceName>Accessory: Femoral Brush Nozzle (Long Nozzle)</deviceName>
    <manufacturerName>Guangzhou Clean Medical Products Manufacturing Corp.</manufacturerName>
    <manufacturerSrn>CN-MF-000008926</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A03040299</emdnCode>
    <emdnDescription>IRRIGATION KITS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5167807</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-05T11:37:15.507Z</lastUpdated>
  </row>
  <row>
    <udiDi>06951233720880</udiDi>
    <basicUdiDi>B-06951233720880</basicUdiDi>
    <tradeName>ic-lavage femoral brush with suction</tradeName>
    <deviceName>Accessory: Femoral Brush Nozzle (Long Nozzle)</deviceName>
    <manufacturerName>Guangzhou Clean Medical Products Manufacturing Corp.</manufacturerName>
    <manufacturerSrn>CN-MF-000008926</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A03040299</emdnCode>
    <emdnDescription>IRRIGATION KITS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>00678003</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-05T11:37:14.649Z</lastUpdated>
  </row>
  <row>
    <udiDi>06951233720675</udiDi>
    <basicUdiDi>B-06951233720675</basicUdiDi>
    <tradeName>AC Power Adapter</tradeName>
    <deviceName>Accessory: AC Power Supply for Disposable Electronically Pulsed Lavage Suction Apparatus (AC Power Adapter)</deviceName>
    <manufacturerName>Guangzhou Clean Medical Products Manufacturing Corp.</manufacturerName>
    <manufacturerSrn>CN-MF-000008926</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A03040299</emdnCode>
    <emdnDescription>IRRIGATION KITS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W-205-01B</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-05T11:37:13.839Z</lastUpdated>
  </row>
  <row>
    <udiDi>06951233720583</udiDi>
    <basicUdiDi>B-06951233720583</basicUdiDi>
    <tradeName>PulsaClean® Fan Spray Nozzle</tradeName>
    <deviceName>Accessory: Fan Spray Nozzle (Short Nozzle)</deviceName>
    <manufacturerName>Guangzhou Clean Medical Products Manufacturing Corp.</manufacturerName>
    <manufacturerSrn>CN-MF-000008926</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A03040299</emdnCode>
    <emdnDescription>IRRIGATION KITS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LD 1020</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-05T11:37:13.035Z</lastUpdated>
  </row>
  <row>
    <udiDi>06951233720576</udiDi>
    <basicUdiDi>B-06951233720576</basicUdiDi>
    <tradeName>PulsaClean® Femoral Brush Nozzle</tradeName>
    <deviceName>Accessory: Femoral Brush Nozzle (Long Nozzle)</deviceName>
    <manufacturerName>Guangzhou Clean Medical Products Manufacturing Corp.</manufacturerName>
    <manufacturerSrn>CN-MF-000008926</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A03040299</emdnCode>
    <emdnDescription>IRRIGATION KITS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LD 1010</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-05T11:37:08.235Z</lastUpdated>
  </row>
  <row>
    <udiDi>06951233720569</udiDi>
    <basicUdiDi>B-06951233720569</basicUdiDi>
    <tradeName>PulsaClean® Disposable Pulse Lavage System</tradeName>
    <deviceName>Disposable Electronically Pulsed Lavage Suction Apparatus</deviceName>
    <manufacturerName>Guangzhou Clean Medical Products Manufacturing Corp.</manufacturerName>
    <manufacturerSrn>CN-MF-000008926</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A03040299</emdnCode>
    <emdnDescription>IRRIGATION KITS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LD 1000</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-05T11:37:07.436Z</lastUpdated>
  </row>
  <row>
    <udiDi>06951233720460</udiDi>
    <basicUdiDi>B-06951233720460</basicUdiDi>
    <tradeName>Large Splash Shield</tradeName>
    <deviceName>Accessory: Large Splash Shield</deviceName>
    <manufacturerName>Guangzhou Clean Medical Products Manufacturing Corp.</manufacturerName>
    <manufacturerSrn>CN-MF-000008926</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A03040299</emdnCode>
    <emdnDescription>IRRIGATION KITS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W-202-P11(EC)</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-05T11:37:06.624Z</lastUpdated>
  </row>
  <row>
    <udiDi>06951233720453</udiDi>
    <basicUdiDi>B-06951233720453</basicUdiDi>
    <tradeName>Femoral Brush Nozzle (Long Nozzle)</tradeName>
    <deviceName>Accessory: Femoral Brush Nozzle (Long Nozzle)</deviceName>
    <manufacturerName>Guangzhou Clean Medical Products Manufacturing Corp.</manufacturerName>
    <manufacturerSrn>CN-MF-000008926</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A03040299</emdnCode>
    <emdnDescription>IRRIGATION KITS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W-202-P3(EC)</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-05T11:37:05.832Z</lastUpdated>
  </row>
  <row>
    <udiDi>06951233720897</udiDi>
    <basicUdiDi>B-06951233720897</basicUdiDi>
    <tradeName>PALABOWL ® Bone Cement Mixing System</tradeName>
    <deviceName>Bone Cement Mixing System</deviceName>
    <manufacturerName>Guangzhou Clean Medical Products Manufacturing Corp.</manufacturerName>
    <manufacturerSrn>CN-MF-000008926</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P099002</emdnCode>
    <emdnDescription>ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5050166</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-05T03:45:49.373Z</lastUpdated>
  </row>
  <row>
    <udiDi>06951233720644</udiDi>
    <basicUdiDi>B-06951233720644</basicUdiDi>
    <tradeName>EASYMIX® bowl</tradeName>
    <deviceName>Bone Cement Mixing System</deviceName>
    <manufacturerName>Guangzhou Clean Medical Products Manufacturing Corp.</manufacturerName>
    <manufacturerSrn>CN-MF-000008926</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P099002</emdnCode>
    <emdnDescription>ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LD2000</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-04T03:55:34.735Z</lastUpdated>
  </row>
  <row>
    <udiDi>06951233720712</udiDi>
    <basicUdiDi>B-06951233720712</basicUdiDi>
    <tradeName>Disposable Electronically Pulsed Lavage Suction Apparatus</tradeName>
    <deviceName>Disposable Electronically Pulsed Lavage Suction Apparatus</deviceName>
    <manufacturerName>Guangzhou Clean Medical Products Manufacturing Corp.</manufacturerName>
    <manufacturerSrn>CN-MF-000008926</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A03040299</emdnCode>
    <emdnDescription>IRRIGATION KITS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W-205-02-B(EC)</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T06:40:25.644Z</lastUpdated>
  </row>
  <row>
    <udiDi>06951233720699</udiDi>
    <basicUdiDi>B-06951233720699</basicUdiDi>
    <tradeName>Disposable Electronically Pulsed Lavage Suction Apparatus</tradeName>
    <deviceName>Disposable Electronically Pulsed Lavage Suction Apparatus</deviceName>
    <manufacturerName>Guangzhou Clean Medical Products Manufacturing Corp.</manufacturerName>
    <manufacturerSrn>CN-MF-000008926</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A03040299</emdnCode>
    <emdnDescription>IRRIGATION KITS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W-205-02-A(EC)</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T06:40:24.931Z</lastUpdated>
  </row>
</eudamedExport>