Identity
- Trade Name
- SPIRO Humidifier EUDAMED
- Device Name
- SPIRO Humidifier EUDAMED
- Model / Reference
- 702 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07350061230001 EUDAMED
- Basic UDI-DI
- B-07350061230001 EUDAMED
- EMDN Code
- R040201 TRACHEOSTOMY HUMIDIFIERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Sweden 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
SPIRO Humidifier by Fogless International Ab — 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-07350061230001 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Fogless International AB
- EUDAMED SRN
- SE-MF-000001616
Sources (1)
- EUDAMED 32cf2bcb-bdbb-46ec-90d5-d8c60c6096a1 61 fields · synced Jun 11, 2026