Identity
- Device Name
- Faros 360 EUDAMED
- Model / Reference
- 360 EUDAMED9404300 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-Faros360X9 EUDAMED
- Basic UDI-DI
- B-Faros360X9 EUDAMED
- EMDN Code
- Z12050403 ECG HOLTER RECORDERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Finland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Faros 360 by Bittium Biosignals Oy — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-Faros360X9 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Bittium Biosignals Oy
- EUDAMED SRN
- FI-MF-000013983
Sources (1)
- EUDAMED 152868f7-d162-43ab-9197-f80c25d3fe70 61 fields · synced May 21, 2026