BODYSTAT LTD

Address:Ballakaap, Ballafletcher Road,Isle of Man,IM

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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

Analyzer, Body Composition (MNW) (4) Analyzer, Body Composition, Exempt (PUH) (2)

Premarket Exempt

No Yes

Clear

Bodystat - 05060502140005 Catalog Number :

Device Description : Bodystat 500 using Bioelectrical Impedance

Device Class : 2

Duns Number: 232767004

Premarket Exempt : Yes

Product Code : PUH

Prescription Use : No

Device Count : 1

Bodystat - 05060502140012 Catalog Number :

Device Description : Bodystat 1000 Body Composition Monitoring Unit using Bioelectrical Impedance Ana Bodystat 1000 Body Composition Monitoring Unit using Bioelectrical Impedance Analysis (BIA)

Device Class : 2

Duns Number: 232767004

Premarket Exempt : Yes

Product Code : PUH

Prescription Use : No

Device Count : 1

Bodystat - 05060502140029 Catalog Number :

Device Description : Bodystat 1500 Body Composition Monitoring Unit using Bioelectrical Impedance Ana Bodystat 1500 Body Composition Monitoring Unit using Bioelectrical Impedance Analysis (BIA)

Device Class : 2

Duns Number: 232767004

Premarket Exempt : No

Product Code : MNW

Prescription Use : No

Device Count : 1

Bodystat - 05060502140036 Catalog Number :

Device Description : Bodystat 1500MDD Body Composition & Fluid Monitoring Unit using Bioelectrical Im Bodystat 1500MDD Body Composition & Fluid Monitoring Unit using Bioelectrical Impedance Analysis (BIA)

Device Class : 2

Duns Number: 232767004

Premarket Exempt : No

Product Code : MNW

Prescription Use : No

Device Count : 1

Bodystat - 05060502140043 Catalog Number :

Device Description : Bodystat QuadScan 4000 Body Composition & Fluid Monitoring Unit using Bioelectri Bodystat QuadScan 4000 Body Composition & Fluid Monitoring Unit using Bioelectrical Impedance Analysis (BIA)

Device Class : 2

Duns Number: 232767004

Premarket Exempt : No

Product Code : MNW

Prescription Use : No

Device Count : 1

Bodystat - 05060502140050 Catalog Number :

Device Description : Bodystat MultiScan 5000 Body Composition & Fluid Monitoring Unit using Bioelectr Bodystat MultiScan 5000 Body Composition & Fluid Monitoring Unit using Bioelectrical Impedance

Device Class : 2

Duns Number: 232767004

Premarket Exempt : No

Product Code : MNW

Prescription Use : No

Device Count : 1

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