Fogless International AB

Address:Storgatan 24,Vaggeryd Jonkoping,SE

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Condenser, Heat And Moisture (Artificial Nose) (BYD) (1) Tube Tracheostomy And Tube Cuff (JOH) (1)

Premarket Exempt

Yes No

Clear

SPIRO - 07350061231282 Catalog Number : 770

Device Description : SPIRO Basic Set Humidifier

Device Class : 1

Duns Number: 356432815

Premarket Exempt : Yes

Product Code : BYD

Prescription Use : Yes

Device Count : 1

SPIRO - 07350061231350 Catalog Number : 740-25; 740-100

Device Description : SPIRO Filter

Device Class :

Duns Number: 356432815

Premarket Exempt : No

Product Code : JOH

Prescription Use : Yes

Device Count : 1

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