Arjohuntleigh AB

Address:HANS MICHELSENSGATAN 10,MALMO Skane,SE

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Filters

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

Mattress, Flotation Therapy, Non-Powered (IKY) (5) Mattress, Air Flotation, Alternating Pressure (FNM) (4) SLEEVE, LIMB, COMPRESSIBLE (JOW) (1)

Premarket Exempt

No Yes

Clear

Auralis - 05059441200963 Catalog Number :

Device Description : AURALIS PLUS LONG SQUAB

Device Class : 2

Duns Number: 355804758

Premarket Exempt : Yes

Product Code : FNM

Prescription Use : No

Device Count : 1

Auralis - 05059441200994 Catalog Number :

Device Description : AURALIS PLUS SHORT SQUAB

Device Class : 2

Duns Number: 355804758

Premarket Exempt : Yes

Product Code : FNM

Prescription Use : No

Device Count : 1

Therarest - 05059441268475 Catalog Number :

Device Description : Therarest, - Reactive Mattress Replacement

Device Class : 1

Duns Number: 355804758

Premarket Exempt : Yes

Product Code : IKY

Prescription Use : No

Device Count : 1

Therarest - 05059441268482 Catalog Number :

Device Description : Therarest, - Reactive Mattress Replacement

Device Class : 1

Duns Number: 355804758

Premarket Exempt : Yes

Product Code : IKY

Prescription Use : No

Device Count : 1

Therarest - 05059441268499 Catalog Number :

Device Description : Therarest VE, - Reactive Mattress Replacement

Device Class : 1

Duns Number: 355804758

Premarket Exempt : Yes

Product Code : IKY

Prescription Use : No

Device Count : 1

Therarest - 05059441268505 Catalog Number :

Device Description : Therarest, - Reactive Mattress Replacement

Device Class : 1

Duns Number: 355804758

Premarket Exempt : Yes

Product Code : IKY

Prescription Use : No

Device Count : 1

Therarest - 05059441268512 Catalog Number :

Device Description : Therarest, - Reactive Mattress Replacement

Device Class : 1

Duns Number: 355804758

Premarket Exempt : Yes

Product Code : IKY

Prescription Use : No

Device Count : 1

AtmosAir Velaris - 05059441900535 Catalog Number :

Device Description : AtmosAir Velaris Mattress - Standard - 810 x 2000 x 180 mm (32 x 79 x 7 in) - T AtmosAir Velaris Mattress - Standard - 810 x 2000 x 180 mm (32 x 79 x 7 in) - Top Cover Reliant

Device Class : 2

Duns Number: 355804758

Premarket Exempt : Yes

Product Code : FNM

Prescription Use : No

Device Count : 1

AtmosAir Velaris - 05059441900542 Catalog Number :

Device Description : AtmosAir Velaris Mattress - Standard - 810 x 2000 x 180 mm (32 x 79 x 7 in) - T AtmosAir Velaris Mattress - Standard - 810 x 2000 x 180 mm (32 x 79 x 7 in) - Top Cover Premium

Device Class : 2

Duns Number: 355804758

Premarket Exempt : Yes

Product Code : FNM

Prescription Use : No

Device Count : 1

Flowtron - 15055982700679 Catalog Number :

Device Description : DVT Prevention Compression Garment -DVT10 CALF

Device Class :

Duns Number: 355804758

Premarket Exempt : No

Product Code : JOW

Prescription Use : Yes

Device Count : 10

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