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Hyperthermic Perfusion Kit

by ThermaSolutions Europe BV Netherlands EUDAMED

Ref TSP1016

EMDN Z12040219

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-00851450007138 Basic UDI-DIDate26 Oct 2023RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/MDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Model / Reference
TSP1016
Primary DI / UDI-DI
00851450007138
Basic UDI-DI
B-00851450007138
EMDN Code
Z12040219 Regional perfusion units
Device Class
Class IIa
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
NL-MF-000022782

Other devices from ThermaSolutions Europe BV

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Administering Medicine
  • Measuring Function
Other properties (8)
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED a10d66a8-215c-43c7-9cac-1cbf564649ea 61 fields · synced 23 Oct 2026