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Spiro

by Fogless International AB 13 variants

Ref 702-5KModel 702

Spiro (702-5K) is a Class IIa device made by Fogless International Ab, registered in EUDAMED on 10 Jun 2026 (Basic UDI-DI B-27350061230029), active as of 24 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-27350061230029 Basic UDI-DI Date10 Jun 2026RegisteredStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Active

Specification

EUDAMED

Device name
Humidifier
Model / reference
702, 702-5K
Primary DI / UDI-DI
27350061230029, 47350061230023
Basic UDI-DI
B-27350061230029, B-47350061230023
EMDN code
R040201 Tracheostomy humidifiers
Device class
Class IIa
EU registration type
Legacy device (under a directive)
EU market of registration
Sweden
Germany

Manufacturer details

EUDAMED SRN
SE-MF-000001616

Similar devices in this category

Other devices filed under TRACHEOSTOMY HUMIDIFIERS.

Other devices from Fogless International Ab

See all devices from Fogless International Ab →

Properties

Other properties (12, all answered No)