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Spiro

by Fogless International AB 13 variants

Ref 710R-2KModel 710R

Spiro (710R-2K) is a Class IIa device made by Fogless International Ab, registered in EUDAMED on 11 Jun 2026 (Basic UDI-DI B-47350061230115), active as of 25 Oct 2026.

Active European Union

CE MDD

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-47350061230115 Basic UDI-DI 47350061230115UDI-DIDate11 Jun 2026RegisteredStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Active

Specification

EUDAMED

Device name
Speaking Valve with oxygen nipple
Model / reference
710R, 710R-2K
Primary DI / UDI-DI
47350061230115
Basic UDI-DI
B-47350061230115
EMDN code
R90060202 Phonation valves for tracheostomy not for ventilator use
Device class
Class IIa
EU registration type
Legacy device (under a directive)
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
SE-MF-000001616

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Properties

Other properties (12, all answered No)