Identity
- Trade Name
- SPIRO EUDAMED
- Device Name
- SPIRO Shower Protector (for Speaking Valve) EUDAMED
- Model / Reference
- 730 EUDAMED730-2K EUDAMED
Identifiers
- Primary DI / UDI-DI
- 17350061230343 EUDAMED
- Basic UDI-DI
- 73500612300779 EUDAMED
- EMDN Code
- R900680 PHONATION VALVES - ACCESSORIES 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 | 73500612300779 | Class I | Active |
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Manufacturer
- Manufacturer
- Fogless International AB
- EUDAMED SRN
- SE-MF-000001616
Sources (1)
- EUDAMED 7ce95a05-944d-4fad-991e-1328f9cce05f 61 fields · synced May 23, 2026