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Faros Pro

by Bittium Biosignals Oy Finland EUDAMED

Ref S0000035721

EMDN Z12050403

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number643003522Cardiac3Z Basic UDI-DIDate29 Jun 2023RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Bittium MINI UL
Model / Reference
S0000035721
Primary DI / UDI-DI
06430035220878
Basic UDI-DI
643003522Cardiac3Z
Direct Marketing DI
06430035220878
EMDN Code
Z12050403 ECG holter recorders
Device Class
Class IIa
Market of Registration
Finland

Manufacturer details

EUDAMED SRN
FI-MF-000013983

Other devices from Bittium Biosignals, Ltd.

See all devices from Bittium Biosignals, Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Measuring Function
Other properties (12)
  • 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
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED d4535186-b75b-475b-b3ca-2c0cd3c4243b 61 fields · synced 24 Oct 2026