<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>04260650335884</udiDi>
    <basicUdiDi>B-04260650335884</basicUdiDi>
    <tradeName>CARESTO heal Carotid Stent Set</tradeName>
    <deviceName>CARESTO heal Carotid Stent Set</deviceName>
    <manufacturerName>Acandis GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006259</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0799</emdnCode>
    <emdnDescription>VASCULAR AND CARDIAC PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01-005311</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-28T08:21:59.588Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260650335860</udiDi>
    <basicUdiDi>B-04260650335860</basicUdiDi>
    <tradeName>CARESTO heal Carotid Stent Set</tradeName>
    <deviceName>CARESTO heal Carotid Stent Set</deviceName>
    <manufacturerName>Acandis GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006259</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0799</emdnCode>
    <emdnDescription>VASCULAR AND CARDIAC PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01-005302</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-28T08:21:44.240Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260650335853</udiDi>
    <basicUdiDi>B-04260650335853</basicUdiDi>
    <tradeName>CARESTO heal Carotid Stent Set</tradeName>
    <deviceName>CARESTO heal Carotid Stent Set</deviceName>
    <manufacturerName>Acandis GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006259</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0799</emdnCode>
    <emdnDescription>VASCULAR AND CARDIAC PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01-005301</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-28T08:21:42.645Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260650335846</udiDi>
    <basicUdiDi>B-04260650335846</basicUdiDi>
    <tradeName>CARESTO heal Carotid Stent Set - Tapered</tradeName>
    <deviceName>CARESTO heal Carotid Stent Set - Tapered</deviceName>
    <manufacturerName>Acandis GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006259</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0799</emdnCode>
    <emdnDescription>VASCULAR AND CARDIAC PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01-005352</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-28T08:21:41.839Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260650335839</udiDi>
    <basicUdiDi>B-04260650335839</basicUdiDi>
    <tradeName>CARESTO heal Carotid Stent Set - Tapered</tradeName>
    <deviceName>CARESTO heal Carotid Stent Set - Tapered</deviceName>
    <manufacturerName>Acandis GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006259</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0799</emdnCode>
    <emdnDescription>VASCULAR AND CARDIAC PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01-005351</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-28T08:21:40.238Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260650335822</udiDi>
    <basicUdiDi>B-04260650335822</basicUdiDi>
    <tradeName>CARESTO heal Carotid Stent Set</tradeName>
    <deviceName>CARESTO heal Carotid Stent Set</deviceName>
    <manufacturerName>Acandis GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006259</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0799</emdnCode>
    <emdnDescription>VASCULAR AND CARDIAC PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01-005324</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-28T08:21:37.838Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260650335815</udiDi>
    <basicUdiDi>B-04260650335815</basicUdiDi>
    <tradeName>CARESTO heal Carotid Stent Set</tradeName>
    <deviceName>CARESTO heal Carotid Stent Set</deviceName>
    <manufacturerName>Acandis GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006259</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0799</emdnCode>
    <emdnDescription>VASCULAR AND CARDIAC PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01-005323</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-28T08:21:36.237Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260650335808</udiDi>
    <basicUdiDi>B-04260650335808</basicUdiDi>
    <tradeName>CARESTO heal Carotid Stent Set</tradeName>
    <deviceName>CARESTO heal Carotid Stent Set</deviceName>
    <manufacturerName>Acandis GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006259</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0799</emdnCode>
    <emdnDescription>VASCULAR AND CARDIAC PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01-005322</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-28T08:21:35.437Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260650335792</udiDi>
    <basicUdiDi>B-04260650335792</basicUdiDi>
    <tradeName>CARESTO heal Carotid Stent Set</tradeName>
    <deviceName>CARESTO heal Carotid Stent Set</deviceName>
    <manufacturerName>Acandis GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006259</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0799</emdnCode>
    <emdnDescription>VASCULAR AND CARDIAC PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01-005321</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-28T08:21:33.831Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260650335785</udiDi>
    <basicUdiDi>B-04260650335785</basicUdiDi>
    <tradeName>CARESTO heal Carotid Stent Set</tradeName>
    <deviceName>CARESTO heal Carotid Stent Set</deviceName>
    <manufacturerName>Acandis GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006259</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0799</emdnCode>
    <emdnDescription>VASCULAR AND CARDIAC PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01-005314</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-28T08:21:31.440Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260650335778</udiDi>
    <basicUdiDi>B-04260650335778</basicUdiDi>
    <tradeName>CARESTO heal Carotid Stent Set</tradeName>
    <deviceName>CARESTO heal Carotid Stent Set</deviceName>
    <manufacturerName>Acandis GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006259</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0799</emdnCode>
    <emdnDescription>VASCULAR AND CARDIAC PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01-005313</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-28T08:21:29.827Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260650332913</udiDi>
    <basicUdiDi>B-04260650332913</basicUdiDi>
    <tradeName>CARESTO heal Carotid Stent Set - Tapered</tradeName>
    <deviceName>CARESTO heal Carotid Stent Set - Tapered</deviceName>
    <manufacturerName>Acandis GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006259</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0799</emdnCode>
    <emdnDescription>VASCULAR AND CARDIAC PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01-005362</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-28T08:21:29.040Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260650332906</udiDi>
    <basicUdiDi>B-04260650332906</basicUdiDi>
    <tradeName>CARESTO heal Carotid Stent Set - Tapered</tradeName>
    <deviceName>CARESTO heal Carotid Stent Set - Tapered</deviceName>
    <manufacturerName>Acandis GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006259</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0799</emdnCode>
    <emdnDescription>VASCULAR AND CARDIAC PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01-005361</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-28T08:21:27.430Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260650332890</udiDi>
    <basicUdiDi>B-04260650332890</basicUdiDi>
    <tradeName>CARESTO heal Carotid Stent Set - Tapered</tradeName>
    <deviceName>CARESTO heal Carotid Stent Set - Tapered</deviceName>
    <manufacturerName>Acandis GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006259</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0799</emdnCode>
    <emdnDescription>VASCULAR AND CARDIAC PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01-005353</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-28T08:21:25.030Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817508012806</udiDi>
    <basicUdiDi>081750801DynamXVIR4F</basicUdiDi>
    <tradeName>DynamX Sirolimus Eluting Coronary Bioadaptor System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Elixir Medical Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000013041</manufacturerSrn>
    <authorisedRepresentativeName>Acorn Regulatory Consultancy Services Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000592</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>P07040199</emdnCode>
    <emdnDescription>VASCULAR ENDOPROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VIR2218</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-26T14:51:39.047Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817508012813</udiDi>
    <basicUdiDi>081750801DynamXVIR4F</basicUdiDi>
    <tradeName>DynamX Sirolimus Eluting Coronary Bioadaptor System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Elixir Medical Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000013041</manufacturerSrn>
    <authorisedRepresentativeName>Acorn Regulatory Consultancy Services Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000592</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>P07040199</emdnCode>
    <emdnDescription>VASCULAR ENDOPROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VIR2223</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-26T14:51:39.029Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817508012820</udiDi>
    <basicUdiDi>081750801DynamXVIR4F</basicUdiDi>
    <tradeName>DynamX Sirolimus Eluting Coronary Bioadaptor System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Elixir Medical Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000013041</manufacturerSrn>
    <authorisedRepresentativeName>Acorn Regulatory Consultancy Services Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000592</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>P07040199</emdnCode>
    <emdnDescription>VASCULAR ENDOPROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VIR2228</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-26T14:51:39.010Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817508012837</udiDi>
    <basicUdiDi>081750801DynamXVIR4F</basicUdiDi>
    <tradeName>DynamX Sirolimus Eluting Coronary Bioadaptor System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Elixir Medical Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000013041</manufacturerSrn>
    <authorisedRepresentativeName>Acorn Regulatory Consultancy Services Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000592</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>P07040199</emdnCode>
    <emdnDescription>VASCULAR ENDOPROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VIR2232</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-26T14:51:38.992Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817508012844</udiDi>
    <basicUdiDi>081750801DynamXVIR4F</basicUdiDi>
    <tradeName>DynamX Sirolimus Eluting Coronary Bioadaptor System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Elixir Medical Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000013041</manufacturerSrn>
    <authorisedRepresentativeName>Acorn Regulatory Consultancy Services Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000592</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>P07040199</emdnCode>
    <emdnDescription>VASCULAR ENDOPROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VIR2238</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-26T14:51:38.971Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817508012851</udiDi>
    <basicUdiDi>081750801DynamXVIR4F</basicUdiDi>
    <tradeName>DynamX Sirolimus Eluting Coronary Bioadaptor System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Elixir Medical Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000013041</manufacturerSrn>
    <authorisedRepresentativeName>Acorn Regulatory Consultancy Services Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000592</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>P07040199</emdnCode>
    <emdnDescription>VASCULAR ENDOPROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VIR2514</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-26T14:51:38.943Z</lastUpdated>
  </row>
</eudamedExport>