<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>03701459807338</udiDi>
    <basicUdiDi>B-03701459807338</basicUdiDi>
    <tradeName>AB THERMO - T2/B</tradeName>
    <deviceName>AB THERMO</deviceName>
    <manufacturerName>GROUPE SOBER SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000017818</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>M030504</emdnCode>
    <emdnDescription>IMMOBILISATION SYSTEMS, MOULDABLE UNDER COLD AND HOT TEMPRATURES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AB THERMO</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-24T20:28:57.258Z</lastUpdated>
  </row>
  <row>
    <udiDi>03701459807321</udiDi>
    <basicUdiDi>B-03701459807321</basicUdiDi>
    <tradeName>AB THERMO - T1/B</tradeName>
    <deviceName>AB THERMO</deviceName>
    <manufacturerName>GROUPE SOBER SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000017818</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>M030504</emdnCode>
    <emdnDescription>IMMOBILISATION SYSTEMS, MOULDABLE UNDER COLD AND HOT TEMPRATURES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AB THERMO</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-24T20:28:56.541Z</lastUpdated>
  </row>
  <row>
    <udiDi>03701459801138</udiDi>
    <basicUdiDi>B-03701459801138</basicUdiDi>
    <tradeName>ACH THERMO</tradeName>
    <deviceName>ACH THERMO</deviceName>
    <manufacturerName>GROUPE SOBER SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000017818</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>M030504</emdnCode>
    <emdnDescription>IMMOBILISATION SYSTEMS, MOULDABLE UNDER COLD AND HOT TEMPRATURES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ACH THERMO</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-24T12:22:26.101Z</lastUpdated>
  </row>
  <row>
    <udiDi>03701459801121</udiDi>
    <basicUdiDi>B-03701459801121</basicUdiDi>
    <tradeName>ACH THERMO</tradeName>
    <deviceName>ACH THERMO</deviceName>
    <manufacturerName>GROUPE SOBER SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000017818</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>M030504</emdnCode>
    <emdnDescription>IMMOBILISATION SYSTEMS, MOULDABLE UNDER COLD AND HOT TEMPRATURES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ACH THERMO</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-24T12:22:25.303Z</lastUpdated>
  </row>
  <row>
    <udiDi>03701459801114</udiDi>
    <basicUdiDi>B-03701459801114</basicUdiDi>
    <tradeName>ACH THERMO</tradeName>
    <deviceName>ACH THERMO</deviceName>
    <manufacturerName>GROUPE SOBER SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000017818</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>M030504</emdnCode>
    <emdnDescription>IMMOBILISATION SYSTEMS, MOULDABLE UNDER COLD AND HOT TEMPRATURES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ACH THERMO</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-24T12:22:24.509Z</lastUpdated>
  </row>
  <row>
    <udiDi>03701459801107</udiDi>
    <basicUdiDi>B-03701459801107</basicUdiDi>
    <tradeName>ACH THERMO</tradeName>
    <deviceName>ACH THERMO</deviceName>
    <manufacturerName>GROUPE SOBER SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000017818</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>M030504</emdnCode>
    <emdnDescription>IMMOBILISATION SYSTEMS, MOULDABLE UNDER COLD AND HOT TEMPRATURES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ACH THERMO</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-24T12:22:20.503Z</lastUpdated>
  </row>
  <row>
    <udiDi>03701459810666</udiDi>
    <basicUdiDi>37014598TECCRY004STKZ</basicUdiDi>
    <tradeName>CRYOSTAB COMBO</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GROUPE SOBER SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000017818</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>M030504</emdnCode>
    <emdnDescription>IMMOBILISATION SYSTEMS, MOULDABLE UNDER COLD AND HOT TEMPRATURES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CRYOSTAB COMBO</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-24T12:18:23.653Z</lastUpdated>
  </row>
  <row>
    <udiDi>03701459810741</udiDi>
    <basicUdiDi>37014598TECCRY004STKZ</basicUdiDi>
    <tradeName>CRYOSTAB 14X14 CP</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GROUPE SOBER SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000017818</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>M030504</emdnCode>
    <emdnDescription>IMMOBILISATION SYSTEMS, MOULDABLE UNDER COLD AND HOT TEMPRATURES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CRYOSTAB 14X14 CP</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-24T12:18:23.459Z</lastUpdated>
  </row>
  <row>
    <udiDi>03701459810758</udiDi>
    <basicUdiDi>37014598TECCRY004STKZ</basicUdiDi>
    <tradeName>CRYOSTAB SET GENOU</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GROUPE SOBER SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000017818</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>M030504</emdnCode>
    <emdnDescription>IMMOBILISATION SYSTEMS, MOULDABLE UNDER COLD AND HOT TEMPRATURES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CRYOSTAB SET GENOU</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-24T12:18:23.436Z</lastUpdated>
  </row>
  <row>
    <udiDi>03701459810789</udiDi>
    <basicUdiDi>37014598TECCRY004STKZ</basicUdiDi>
    <tradeName>CRYOSTAB PACK GENOU</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GROUPE SOBER SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000017818</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>M030504</emdnCode>
    <emdnDescription>IMMOBILISATION SYSTEMS, MOULDABLE UNDER COLD AND HOT TEMPRATURES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CRYOSTAB PACK GENOU</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-24T12:18:23.415Z</lastUpdated>
  </row>
  <row>
    <udiDi>03701459806782</udiDi>
    <basicUdiDi>B-03701459806782</basicUdiDi>
    <tradeName>ARM THERMO - T3</tradeName>
    <deviceName>ARM THERMO</deviceName>
    <manufacturerName>GROUPE SOBER SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000017818</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>M030504</emdnCode>
    <emdnDescription>IMMOBILISATION SYSTEMS, MOULDABLE UNDER COLD AND HOT TEMPRATURES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ARM THERMO</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-23T20:19:31.546Z</lastUpdated>
  </row>
  <row>
    <udiDi>03701459806775</udiDi>
    <basicUdiDi>B-03701459806775</basicUdiDi>
    <tradeName>ARM THERMO - T2</tradeName>
    <deviceName>ARM THERMO</deviceName>
    <manufacturerName>GROUPE SOBER SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000017818</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>M030504</emdnCode>
    <emdnDescription>IMMOBILISATION SYSTEMS, MOULDABLE UNDER COLD AND HOT TEMPRATURES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ARM THERMO</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-23T20:19:30.759Z</lastUpdated>
  </row>
  <row>
    <udiDi>03701459806768</udiDi>
    <basicUdiDi>B-03701459806768</basicUdiDi>
    <tradeName>ARM THERMO - T1</tradeName>
    <deviceName>ARM THERMO</deviceName>
    <manufacturerName>GROUPE SOBER SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000017818</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>M030504</emdnCode>
    <emdnDescription>IMMOBILISATION SYSTEMS, MOULDABLE UNDER COLD AND HOT TEMPRATURES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ARM THERMO</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-23T20:19:29.939Z</lastUpdated>
  </row>
  <row>
    <udiDi>10768627002131</udiDi>
    <basicUdiDi>0768627CSTACC-1002-QD</basicUdiDi>
    <tradeName>Preferred</tradeName>
    <deviceName></deviceName>
    <manufacturerName>North Coast Medical Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000009087</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>M030504</emdnCode>
    <emdnDescription>IMMOBILISATION SYSTEMS, MOULDABLE UNDER COLD AND HOT TEMPRATURES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NC12793-1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T08:47:37.244Z</lastUpdated>
  </row>
  <row>
    <udiDi>10768627002179</udiDi>
    <basicUdiDi>0768627CSTACC-1027-R6</basicUdiDi>
    <tradeName>Omega Max</tradeName>
    <deviceName></deviceName>
    <manufacturerName>North Coast Medical Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000009087</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>M030504</emdnCode>
    <emdnDescription>IMMOBILISATION SYSTEMS, MOULDABLE UNDER COLD AND HOT TEMPRATURES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NC12798-1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T08:47:37.095Z</lastUpdated>
  </row>
  <row>
    <udiDi>10768627002438</udiDi>
    <basicUdiDi>0768627CSTACC-2386-SZ</basicUdiDi>
    <tradeName>Prism</tradeName>
    <deviceName></deviceName>
    <manufacturerName>North Coast Medical Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000009087</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>M030504</emdnCode>
    <emdnDescription>IMMOBILISATION SYSTEMS, MOULDABLE UNDER COLD AND HOT TEMPRATURES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NC12956-1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T08:47:36.996Z</lastUpdated>
  </row>
  <row>
    <udiDi>10768627002452</udiDi>
    <basicUdiDi>0768627CSTACC-2386-SZ</basicUdiDi>
    <tradeName>Prism</tradeName>
    <deviceName></deviceName>
    <manufacturerName>North Coast Medical Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000009087</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>M030504</emdnCode>
    <emdnDescription>IMMOBILISATION SYSTEMS, MOULDABLE UNDER COLD AND HOT TEMPRATURES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NC12957-1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T08:47:36.945Z</lastUpdated>
  </row>
  <row>
    <udiDi>10768627002469</udiDi>
    <basicUdiDi>0768627CSTACC-2386-SZ</basicUdiDi>
    <tradeName>Prism</tradeName>
    <deviceName></deviceName>
    <manufacturerName>North Coast Medical Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000009087</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>M030504</emdnCode>
    <emdnDescription>IMMOBILISATION SYSTEMS, MOULDABLE UNDER COLD AND HOT TEMPRATURES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NC12958-1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T08:47:36.887Z</lastUpdated>
  </row>
  <row>
    <udiDi>10768627002483</udiDi>
    <basicUdiDi>0768627CSTACC-2386-SZ</basicUdiDi>
    <tradeName>Prism</tradeName>
    <deviceName></deviceName>
    <manufacturerName>North Coast Medical Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000009087</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>M030504</emdnCode>
    <emdnDescription>IMMOBILISATION SYSTEMS, MOULDABLE UNDER COLD AND HOT TEMPRATURES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NC12964-1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T08:47:36.630Z</lastUpdated>
  </row>
  <row>
    <udiDi>03701422907232</udiDi>
    <basicUdiDi>37014229NOVASPINELM</basicUdiDi>
    <tradeName>03701422907232</tradeName>
    <deviceName>NOVASPINE</deviceName>
    <manufacturerName>NOVATEX MEDICAL SA</manufacturerName>
    <manufacturerSrn>FR-MF-000014276</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>M030504</emdnCode>
    <emdnDescription>IMMOBILISATION SYSTEMS, MOULDABLE UNDER COLD AND HOT TEMPRATURES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>03701422907232</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-22T19:58:11.910Z</lastUpdated>
  </row>
</eudamedExport>