Identity
- Trade Name
- seca 525 FDA UDI
- Generic Name
- Bioelectrical body composition analyser FDA UDI
- Device Name
- The seca 525 medical Body Composition Analyzer is mainly used in hospitals, medical practices and inpatient care facilities in accordance with national regulations. The medical Body Composition Analyzer seca 525 records weight, height and bioelectric impedance measurements and automatically calculates parameters such as fat-free mass (FFM) which can be derived from them. The results are displayed in graphical form and assist the attending physician with the following medical issues: • determining energy expenditure and energy reserves as a basis for nutritional advice • assessing metabolic activity and the success of a training program, e.g. within the framework of rehabilitation or physiotherapy • determining a patient's fluids status The seca 525 is not a diagnostic device. To make an accurate diagnosis, the physician needs to commission specific examinations and take their results into account in addition to the results of the seca 525. The device is not intended for use on children. For North America: the device is intended for use on healthy individuals from 18 years of age upwards. FDA UDI
- Model / Reference
- 525 FDA UDI
- Description
- The seca 525 medical Body Composition Analyzer is mainly used in hospitals, medical practices and inpatient care facilities in accordance with national regulations. The medical Body Composition Analyzer seca 525 records weight, height and bioelectric impedance measurements and automatically calculates parameters such as fat-free mass (FFM) which can be derived from them. The results are displayed in graphical form and assist the attending physician with the following medical issues: • determining energy expenditure and energy reserves as a basis for nutritional advice • assessing metabolic activity and the success of a training program, e.g. within the framework of rehabilitation or physiotherapy • determining a patient's fluids status The seca 525 is not a diagnostic device. To make an accurate diagnosis, the physician needs to commission specific examinations and take their results into account in addition to the results of the seca 525. The device is not intended for use on children. For North America: the device is intended for use on healthy individuals from 18 years of age upwards. FDA UDI
Identifiers
- Catalog Number
- 5250021139 FDA UDI
- Primary DI / UDI-DI
- 04012030016926 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 525 by Seca Corp. — 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
- Seca Corp.
Sources (1)
- FDA UDI 0e8e43be-3270-4f3f-a761-ad210478c4b6 35 fields · synced May 29, 2026