Identity
- Trade Name
- Ozeri FDA UDI
- Generic Name
- Bioelectrical body composition analyser FDA UDI
- Device Name
- Bathroom scale body fat analyzer. Support up to 8 users. Scale supports TARE function. Default unit is LB. Units - kg/lb/st. Batteries included. Utilizes 4 high precision GX sensors to weigh up to 440 pounds (200 kilograms) in 0.2 lbs or 0.1 kg increments with Step On technology. Elegant reflective surface is made of high quality impact-resistant tempered glass, which is 4 times stronger than normal glass. Color- White. This scale is not for clinical or diagnostic use. FDA UDI
- Model / Reference
- ZB13-W FDA UDI
- Description
- Bathroom scale body fat analyzer. Support up to 8 users. Scale supports TARE function. Default unit is LB. Units - kg/lb/st. Batteries included. Utilizes 4 high precision GX sensors to weigh up to 440 pounds (200 kilograms) in 0.2 lbs or 0.1 kg increments with Step On technology. Elegant reflective surface is made of high quality impact-resistant tempered glass, which is 4 times stronger than normal glass. Color- White. This scale is not for clinical or diagnostic use. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00815817012333 FDA UDI
- FDA Product Code
- MNW 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
Ozeri by Commonpath Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- 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
- Commonpath Llc
Sources (1)
- FDA UDI 495a746e-1388-43ad-9978-ec577df9b9be 34 fields · synced May 31, 2026