Identity
- Trade Name
- SPIRO EUDAMED
- Device Name
- Shower Protector (for Humidifier) EUDAMED
- Model / Reference
- 703 EUDAMED703-2K EUDAMED
Identifiers
- Primary DI / UDI-DI
- 17350061230305 EUDAMED
- Basic UDI-DI
- 7350061230026X EUDAMED
- EMDN Code
- R040201 TRACHEOSTOMY HUMIDIFIERS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Sweden EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Spiro by Fogless International Ab — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 7350061230026X | Class I | Active |
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Manufacturer
- Manufacturer
- Fogless International AB
- EUDAMED SRN
- SE-MF-000001616
Sources (1)
- EUDAMED d57f9bf8-7080-4ce8-9163-09a6525a0a60 61 fields · synced May 23, 2026