Identity
- Trade Name
- Mediana Co., Ltd. Body Composition Analyzer I55 FDA UDI
- Generic Name
- Bioelectrical body composition analyser FDA UDI
- Model / Reference
- I55M-XBXUS FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800003466412 FDA UDI
- FDA Product Code
- PUH 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
Yes
FDA UDI
Prescription Use
No
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Bioelectrical body composition analyser
Mediana Co., Ltd. Body Composition Analyzer I55 by Mediana.CO.LTD — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Bioelectrical body composition analyser.
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- RENPHO Body Composition Scale — JOICOM CORPORATION · Class II
- Etekcity — ETEKCITY CORPORATION · Class II
- truME — Shenzhen Belter Health Measurement and Analysis Technology Co., Ltd. · Class II
- CONAIR — CONAIR LLC. · 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
- Mediana.CO.LTD
Sources (1)
- FDA UDI cc63f565-458d-49a6-864e-8d0545af99cc 32 fields · synced May 29, 2026