Identity
- Trade Name
- seca mBCA 545 FDA UDI
- Generic Name
- Bioelectrical body composition analyser FDA UDI
- Device Name
- The BIA handle supports physicians in decision-making regarding diagnosis or therapy based on results of bioelectrical impedance measurements. The BIA handle can be combined with optional accessories and devices to enable the measurements of further parameters. FDA UDI
- Model / Reference
- 545 FDA UDI
- Description
- The BIA handle supports physicians in decision-making regarding diagnosis or therapy based on results of bioelectrical impedance measurements. The BIA handle can be combined with optional accessories and devices to enable the measurements of further parameters. FDA UDI
Identifiers
- Catalog Number
- 5450017009 FDA UDI
- Primary DI / UDI-DI
- 04012030022026 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
No
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
seca mBCA 545 by Seca Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bioelectrical body composition analyser.
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- CONAIR — CONAIR LLC. · Class II
- 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
- Seca Corp.
Sources (1)
- FDA UDI 1dd3910f-3752-41b5-8e85-b42cccc979a6 35 fields · synced May 30, 2026