Skip to content

ThermoHuman

by Pema Thermo Group S.L. EUDAMED

Withdrawn European Union

Ref CAT TH 001

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8437025397THERMOHUMANYZ Basic UDI-DIDate19 Dec 2022RegisteredStatusWithdrawn

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Withdrawn

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Specification

EUDAMED

Model / Reference
CAT TH 001
Primary DI / UDI-DI
08437025397006
Basic UDI-DI
8437025397THERMOHUMANYZ
EMDN Code
Z119092 Various bioimaging and radiotherapy instruments - medical device software
Device Class
Class I
Special Device Type
Software
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
ES-MF-000021785

Properties

Other properties (13)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No