IMPEDIMED LIMITED

Address:Unit 1, 50 Parker Court,Brisbane Queensland,AU

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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

Analyzer, Body Composition (MNW) (7) Monitor, Extracellular Fluid, Lymphedema, Extremity (OBH) (3)

Premarket Exempt

No Yes

Clear

L-Dex® U400 - B277222LDEXU4000 Catalog Number : 222-LDEXU400

Device Description : BIS Extra Cellular Fluid Analysis. It is designed to provide real-time, noninva

Device Class : 2

Duns Number: 757258843

Premarket Exempt : No

Product Code : OBH

Prescription Use : Yes

Device Count : 1

Imp DF50 - B277223DF500 Catalog Number : 223-DF50

Device Description : DF50 Single Frequency Bioimpedance; A bioimpedance (BIA) device to aid in the cl

Device Class : 2

Duns Number: 757258843

Premarket Exempt : No

Product Code : MNW

Prescription Use : No

Device Count : 1

Imp SFB7 - B277223SFB70 Catalog Number : 223-SFB7

Device Description : BIS Extra Cellular Fluid Analysis. It is designed to provide real-time, noninva

Device Class : 2

Duns Number: 757258843

Premarket Exempt : No

Product Code : MNW

Prescription Use : No

Device Count : 1

Imp DF50 - B277229DF500 Catalog Number : 229-DF50

Device Description : DF50 Single Frequency Bioimpedance; A bioimpedance (BIA) device to aid in the cl

Device Class : 2

Duns Number: 757258843

Premarket Exempt : No

Product Code : MNW

Prescription Use : No

Device Count : 1

Imp SFB7 - B277229SFB70 Catalog Number : 229-SFB7

Device Description : BIS Extra Cellular Fluid Analysis. It is designed to provide real-time, noninva

Device Class : 2

Duns Number: 757258843

Premarket Exempt : No

Product Code : MNW

Prescription Use : No

Device Count : 1

SOZO Body Fluid Analyzer - B27724269950 Catalog Number : 242-SOZO

Device Description : SOZO Body Fluid Analyzer working in conjunction with SOZOapp is designed to prov

Device Class : 2

Duns Number: 757258843

Premarket Exempt : No

Product Code : OBH

Prescription Use : Yes

Device Count : 1

L-Dex® U400 - B277242LDEXU4000 Catalog Number : 242-LDEXU400

Device Description : BIS Extra Cellular Fluid Analysis- refurbished. It is designed to provide real-

Device Class : 2

Duns Number: 757258843

Premarket Exempt : No

Product Code : OBH

Prescription Use : Yes

Device Count : 1

Imp DF50 - B277243DF500 Catalog Number : 229-DF50

Device Description : DF50 Single Frequency Bioimpedance; A bioimpedance (BIA) device to aid in the cl

Device Class : 2

Duns Number: 757258843

Premarket Exempt : No

Product Code : MNW

Prescription Use : No

Device Count : 1

Imp SFB7 - B277243SFB70 Catalog Number : 243-SFB7

Device Description : BIS Extra Cellular Fluid Analysis. It is designed to provide real-time, noninva

Device Class : 2

Duns Number: 757258843

Premarket Exempt : No

Product Code : MNW

Prescription Use : No

Device Count : 1

Imp DF50 - B277249DF500 Catalog Number : 229-DF50

Device Description : DF50 Single Frequency Bioimpedance; A bioimpedance (BIA) device to aid in the cl

Device Class : 2

Duns Number: 757258843

Premarket Exempt : No

Product Code : MNW

Prescription Use : No

Device Count : 1

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