Identity
- Trade Name
- SPIRO EUDAMED
- Device Name
- SPIRO Speaking Valve EUDAMED
- Model / Reference
- 711 EUDAMED711-5K EUDAMED
Identifiers
- Primary DI / UDI-DI
- 17350061230152 EUDAMED
- Basic UDI-DI
- 73500612300677 EUDAMED
- EMDN Code
- R900602 PHONATION VALVES FOR TRACHEOSTOMY 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 | 73500612300677 | Class I | Active |
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Manufacturer
- Manufacturer
- Fogless International AB
- EUDAMED SRN
- SE-MF-000001616
Sources (1)
- EUDAMED 5e8eb5f2-8af3-4877-991c-b4f83c010833 61 fields · synced May 25, 2026