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Cardiomax

by Instramed Indústria Médico Hospitalar Ltda. EUDAMED

Active European Union

Ref Cardiomax

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-789850904CARDIOMAXYTM6 Basic UDI-DIDate29 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED

Model / Reference
Cardiomax
Primary DI / UDI-DI
D-789850904CARDIOMAXYTM6
Basic UDI-DI
B-789850904CARDIOMAXYTM6
EMDN Code
C020499 External cardioversion and defibrillation devices - other
Device Class
Class IIb
Market of Registration
Bulgaria

Manufacturer details

EUDAMED SRN
BR-MF-000033452
Authorised representative
Obelis s.a. BE-AR-000000106

Other devices from Instramed Indústria Médico Hospitalar Ltda.

Properties

  • Measuring Function

Other properties (10)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Incorporates Medicinal Product: No