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Hidroxa SE30

by Hidroxa Medical AB

Ref SE30-011

Active European Union

CE MDR

Valid until

4 Jun 2031

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier SLOVENIAN INSTITUTE OF QUALITY AND METROLOGY - SIQ

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberMDR-0042 Date5 Jun 2026IssuedStatusActive expires 4 Jun 2031

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference
SE30-011
Primary DI / UDI-DI
07350151970008
Basic UDI-DI
735015197HidroxaSE30YC
Direct Marketing DI
07350151970008
EMDN Code
Z120604 Iontophoresis equipment
Device Class
Class IIa
EU market of registration
Sweden

Manufacturer details

EUDAMED SRN
SE-MF-000048119

Other devices from Hidroxa Medical AB

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