Spiro
by Fogless International AB 12 variants
Ref 708-2KModel 707; 708
Spiro (708-2K) is a Class I device made by Fogless International Ab, registered in EUDAMED on 12 Jun 2026 (Basic UDI-DI 73500612300473), active as of 25 Oct 2026.
Active
CE MDR
Valid until
No date given
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number73500612300473 27350061230067 | Date12 Jun 2026 | StatusActive |
Official records
- EUDAMED public site 73500612300473
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device name
- Adaptor
- Model / reference
- 707, 708, 708-2K
- Primary DI / UDI-DI
- 27350061230067
- Basic UDI-DI
- 73500612300473
- Unit of use DI
- 07350061231336
- EMDN code
- R040299, R900680
- Device class
- Class I
- EU registration type
- Standard device
- EU market of registration
- Sweden
Manufacturer details
- EUDAMED SRN
- SE-MF-000001616
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