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hctronic

by Heater Cooler B.V. Netherlands EUDAMED

Ref HCS-1

EMDN Z12019080

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8720165944HCS15R Basic UDI-DIDate11 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 24M00085SUP01 Supplemented

    Quality management system EU MDR

    Notified body
    Notified body 1912
    Issued
    23 Apr 2026
    Expires
    6 Oct 2029
    Reason
    Other

Specification

EUDAMED · synced 22 Oct 2026

Device Name
HCTronic Heater-Cooler System
Model / Reference
HCS-1
Primary DI / UDI-DI
08720165944064
Basic UDI-DI
8720165944HCS15R
Direct Marketing DI
08720165944064
EMDN Code
Z12019080 Various instruments for general and multidisciplinary surgery - hardware accessories
Device Class
Class IIb
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
NL-MF-000000246

Properties & raw data

Show properties, registry sources and raw records
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

Sources (1)

  • EUDAMED 6ef7a62e-4693-4199-bc6a-9a2f3d84ff02 61 fields · synced 22 Oct 2026