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Spiro

by Fogless International AB 12 variants

Ref 711-5KModel 711

Spiro (711-5K) is a Class I device made by Fogless International Ab, registered in EUDAMED on 10 Jun 2026 (Basic UDI-DI 73500612300677), active as of 22 Oct 2026.

Active European Union

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number73500612300677 Basic UDI-DI Date10 Jun 2026RegisteredStatusActive

Official records

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device name
Speaking Valve
Model / reference
711, 711-5K
Primary DI / UDI-DI
27350061230159, 47350061230153
Basic UDI-DI
73500612300677
Unit of use DI
07350061231459
EMDN code
R90060202 Phonation valves for tracheostomy not for ventilator use
Device class
Class I
EU registration type
Standard device
EU market of registration
Sweden
Germany

Manufacturer details

EUDAMED SRN
SE-MF-000001616

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Properties

Other properties (14, all answered No)