<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>05903641500111</udiDi>
    <basicUdiDi>590364150IMM2C9</basicUdiDi>
    <tradeName>Impactis M+</tradeName>
    <deviceName>Shock wave physiotherapy unit Impactis M+</deviceName>
    <manufacturerName>ASTAR spółka z ograniczoną odpowiedzialnością</manufacturerName>
    <manufacturerSrn>PL-MF-000010564</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12139001</emdnCode>
    <emdnDescription>SHOCK WAVE THERAPY EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A-UF-AST-IMM+</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T10:06:25.531Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260507450043</udiDi>
    <basicUdiDi>42605074500000005VK</basicUdiDi>
    <tradeName>LiKAWAVE VARIO® 3i</tradeName>
    <deviceName>Shockwave therapy device</deviceName>
    <manufacturerName>Likamed GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006475</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12139001</emdnCode>
    <emdnDescription>SHOCK WAVE THERAPY EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30-01-21</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T23:04:01.035Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260484571106</udiDi>
    <basicUdiDi>426048457OW100OW100SZB</basicUdiDi>
    <tradeName>dermagold100</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MTS Medical AG (Aktiengesellschaft)</manufacturerName>
    <manufacturerSrn>DE-MF-000005447</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12139001</emdnCode>
    <emdnDescription>SHOCK WAVE THERAPY EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1000002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T23:01:30.446Z</lastUpdated>
  </row>
  <row>
    <udiDi>B108844POPRMEU00</udiDi>
    <basicUdiDi>++B108844POPRM5B</basicUdiDi>
    <tradeName>BTL-6000 RSWT Pro</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BTL Industries Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000034894</manufacturerSrn>
    <authorisedRepresentativeName>BTL ITALIA S.r.l.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000020508</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12139001</emdnCode>
    <emdnDescription>SHOCK WAVE THERAPY EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>844-POPRMA-M/844-POPREA-M</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:51:32.178Z</lastUpdated>
  </row>
  <row>
    <udiDi>B108844POELMEU00</udiDi>
    <basicUdiDi>++B108844POELM32</basicUdiDi>
    <tradeName>BTL-6000 RSWT Elite</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BTL Industries Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000034894</manufacturerSrn>
    <authorisedRepresentativeName>BTL ITALIA S.r.l.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000020508</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12139001</emdnCode>
    <emdnDescription>SHOCK WAVE THERAPY EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>844-POELMA-M/844-POELEA-M</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:51:31.545Z</lastUpdated>
  </row>
  <row>
    <udiDi>B108844POEAMEU00</udiDi>
    <basicUdiDi>++B108844POJX</basicUdiDi>
    <tradeName>BTL-6000 RSWT Easy</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BTL Industries Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000034894</manufacturerSrn>
    <authorisedRepresentativeName>BTL ITALIA S.r.l.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000020508</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12139001</emdnCode>
    <emdnDescription>SHOCK WAVE THERAPY EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>844-POEAEA-M</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:51:27.377Z</lastUpdated>
  </row>
  <row>
    <udiDi>B108844APMAMEU00</udiDi>
    <basicUdiDi>++B108844APMAMW8</basicUdiDi>
    <tradeName>Applicator Magnum</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BTL Industries Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000034894</manufacturerSrn>
    <authorisedRepresentativeName>BTL ITALIA S.r.l.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000020508</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12139001</emdnCode>
    <emdnDescription>SHOCK WAVE THERAPY EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>844-APMA-M</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:51:26.580Z</lastUpdated>
  </row>
  <row>
    <udiDi>B108844APEAMEU00</udiDi>
    <basicUdiDi>++B108844APEAMUY</basicUdiDi>
    <tradeName>Applicator Easy</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BTL Industries Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000034894</manufacturerSrn>
    <authorisedRepresentativeName>BTL ITALIA S.r.l.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000020508</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12139001</emdnCode>
    <emdnDescription>SHOCK WAVE THERAPY EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>844-APEA-M</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:51:25.775Z</lastUpdated>
  </row>
  <row>
    <udiDi>B108294PADLBOXMEU00</udiDi>
    <basicUdiDi>++B108294PAD8E</basicUdiDi>
    <tradeName>Coupling pad BTL-294-CP3F Large</tradeName>
    <deviceName>FSWT Coupling pads</deviceName>
    <manufacturerName>BTL Industries Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000034894</manufacturerSrn>
    <authorisedRepresentativeName>BTL ITALIA S.r.l.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000020508</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12139001</emdnCode>
    <emdnDescription>SHOCK WAVE THERAPY EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P094.013</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:51:14.009Z</lastUpdated>
  </row>
  <row>
    <udiDi>B108294APMEU00</udiDi>
    <basicUdiDi>++B108294APEUXH</basicUdiDi>
    <tradeName>FSWT applicator BTL-294-1</tradeName>
    <deviceName>FSWT applicator BTL-294-1</deviceName>
    <manufacturerName>BTL Industries Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000034894</manufacturerSrn>
    <authorisedRepresentativeName>BTL ITALIA S.r.l.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000020508</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12139001</emdnCode>
    <emdnDescription>SHOCK WAVE THERAPY EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P094.002</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:51:12.171Z</lastUpdated>
  </row>
  <row>
    <udiDi>B108214BUM15FMEU00</udiDi>
    <basicUdiDi>++B108214BUMEUTD</basicUdiDi>
    <tradeName>15 mm focused transmitter</tradeName>
    <deviceName>Transmitters</deviceName>
    <manufacturerName>BTL Industries Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000034894</manufacturerSrn>
    <authorisedRepresentativeName>BTL ITALIA S.r.l.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000020508</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12139001</emdnCode>
    <emdnDescription>SHOCK WAVE THERAPY EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P014.014</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:50:45.404Z</lastUpdated>
  </row>
  <row>
    <udiDi>B108094POMEU00</udiDi>
    <basicUdiDi>++B108094POEUZK</basicUdiDi>
    <tradeName>BTL-6000 FSWT</tradeName>
    <deviceName>BTL-6000 FSWT</deviceName>
    <manufacturerName>BTL Industries Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000034894</manufacturerSrn>
    <authorisedRepresentativeName>BTL ITALIA S.r.l.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000020508</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12139001</emdnCode>
    <emdnDescription>SHOCK WAVE THERAPY EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P094.001</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:50:44.635Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF0000138282500PT</udiDi>
    <basicUdiDi>B-CNMF0000138282500PT</basicUdiDi>
    <tradeName>Electrical Extracorporeal Shock  Wave Therapy Device</tradeName>
    <deviceName>Electrical Extracorporeal Shock Wave Therapy Device</deviceName>
    <manufacturerName>Guangzhou Longest Science &amp; Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013828</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12139001</emdnCode>
    <emdnDescription>SHOCK WAVE THERAPY EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NA</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-13T02:12:06.924Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800066600082</udiDi>
    <basicUdiDi>B-08800066600082</basicUdiDi>
    <tradeName>Zeus Wave</tradeName>
    <deviceName>Zeus Wave(Piezo-Type+Pneumatic-Type)</deviceName>
    <manufacturerName>Wever Instruments. Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000008615</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12139001</emdnCode>
    <emdnDescription>SHOCK WAVE THERAPY EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZW-IFU-01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T02:12:58.550Z</lastUpdated>
  </row>
  <row>
    <udiDi>08680050920361</udiDi>
    <basicUdiDi>B-08680050920361</basicUdiDi>
    <tradeName>Extracorporeal Shockwave Therapy (ESWT)</tradeName>
    <deviceName>Extracorporeal Shockwave Therapy</deviceName>
    <manufacturerName>İnceler Medikal Sağlık Hizmetleri Sanayi Ticaret Limited Şirketi</manufacturerName>
    <manufacturerSrn>TR-MF-000024864</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12139001</emdnCode>
    <emdnDescription>SHOCK WAVE THERAPY EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IMED-850</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-08T00:06:56.065Z</lastUpdated>
  </row>
  <row>
    <udiDi>08680050920224</udiDi>
    <basicUdiDi>B-08680050920224</basicUdiDi>
    <tradeName>Extracorporeal Shockwave Therapy (ESWT)</tradeName>
    <deviceName>Extracorporeal Shockwave Therapy (ESWT)</deviceName>
    <manufacturerName>İnceler Medikal Sağlık Hizmetleri Sanayi Ticaret Limited Şirketi</manufacturerName>
    <manufacturerSrn>TR-MF-000024864</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12139001</emdnCode>
    <emdnDescription>SHOCK WAVE THERAPY EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IMET-800</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-08T00:06:35.212Z</lastUpdated>
  </row>
  <row>
    <udiDi>08051499970147</udiDi>
    <basicUdiDi>B-08051499970147</basicUdiDi>
    <tradeName>PulsWave Plus</tradeName>
    <deviceName>PULSWAVE PLUS</deviceName>
    <manufacturerName>Mectronic Medicale srl</manufacturerName>
    <manufacturerSrn>IT-MF-000040989</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12139001</emdnCode>
    <emdnDescription>SHOCK WAVE THERAPY EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11MMP.PW.0,2JF10</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T16:12:55.629Z</lastUpdated>
  </row>
  <row>
    <udiDi>07630039101398</udiDi>
    <basicUdiDi>B-07630039101398</basicUdiDi>
    <tradeName>DUOLITH SD1 T-Top</tradeName>
    <deviceName>DUOLITH SD1 T-Top</deviceName>
    <manufacturerName>STORZ MEDICAL AG</manufacturerName>
    <manufacturerSrn>CH-MF-000014374</manufacturerSrn>
    <authorisedRepresentativeName>STORZ MEDICAL Deutschland GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000009017</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12139001</emdnCode>
    <emdnDescription>SHOCK WAVE THERAPY EQUIPMENT</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>21362.0102</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:57:32.854Z</lastUpdated>
  </row>
  <row>
    <udiDi>07630039101213</udiDi>
    <basicUdiDi>B-07630039101213</basicUdiDi>
    <tradeName>D-ACTOR ONE</tradeName>
    <deviceName>D-ACTOR ONE</deviceName>
    <manufacturerName>STORZ MEDICAL AG</manufacturerName>
    <manufacturerSrn>CH-MF-000014374</manufacturerSrn>
    <authorisedRepresentativeName>STORZ MEDICAL Deutschland GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000009017</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12139001</emdnCode>
    <emdnDescription>SHOCK WAVE THERAPY EQUIPMENT</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>30943.0002</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:57:26.461Z</lastUpdated>
  </row>
  <row>
    <udiDi>07630039101169</udiDi>
    <basicUdiDi>B-07630039101169</basicUdiDi>
    <tradeName>MASTERPULS ONE</tradeName>
    <deviceName>MASTERPULS ONE</deviceName>
    <manufacturerName>STORZ MEDICAL AG</manufacturerName>
    <manufacturerSrn>CH-MF-000014374</manufacturerSrn>
    <authorisedRepresentativeName>STORZ MEDICAL Deutschland GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000009017</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12139001</emdnCode>
    <emdnDescription>SHOCK WAVE THERAPY EQUIPMENT</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>27800.0012</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:57:18.461Z</lastUpdated>
  </row>
</eudamedExport>