Identity
- Trade Name
- MYSOZO.com FDA UDI
- Generic Name
- Bioelectrical body composition analyser FDA UDI
- Device Name
- Multipurpose software application- impedance analysis software that supports the measurement of extracellular fluid volume differences between the limbs and in the whole body, to track changes in the fluid state overtime; impedance analysis software utilizing impedance ratios that are displayed as an L-Dex ratio, that supports the measurement of extracellular fluid volume differences between the limbs and is presented to the clinician on an L-Dex scale. FDA UDI
- Model / Reference
- V 5.0.0 FDA UDI
- Description
- Multipurpose software application- impedance analysis software that supports the measurement of extracellular fluid volume differences between the limbs and in the whole body, to track changes in the fluid state overtime; impedance analysis software utilizing impedance ratios that are displayed as an L-Dex ratio, that supports the measurement of extracellular fluid volume differences between the limbs and is presented to the clinician on an L-Dex scale. FDA UDI
Identifiers
- Catalog Number
- SFT-025 FDA UDI
- Primary DI / UDI-DI
- B277SFT0250 FDA UDI
- FDA Product Code
- DSB FDA UDIOBH FDA UDI
- GMDN Term
- Bioelectrical body composition analyser FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2770 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Bioelectrical body composition analyser
MYSOZO.com by Impedimed, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- CONAIR — CONAIR LLC. · Class II
- TANITA/Ironman Body Composition Analyzer — Tanita Corp. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Impedimed, Inc.
Sources (1)
- FDA UDI 70332b4b-8d4e-4d6f-9faf-2a72e7a8e794 35 fields · synced Jun 1, 2026