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InBody580
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref R6Model InBody580Ref V8Model InBody280
Identity
- Trade Name
- InBody580 EUDAMEDInBody280 EUDAMEDInBody FDA UDI
- Generic Name
- Bioelectrical body composition analyser FDA UDI
- Device Name
- ANALYZER, BODY COMPOSITION EUDAMEDBody Composition Analyzer FDA UDI
- Model / Reference
- InBody580 EUDAMEDR6 EUDAMEDInBody280 EUDAMEDV8 EUDAMEDInBody 580 FDA UDI
- Description
- Body Composition Analyzer FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809209591683 EUDAMEDFDA UDI08809209592321 EUDAMED
- Basic UDI-DI
- 880920959R6ZP EUDAMED880920959V82A EUDAMED
- Direct Marketing DI
- 08809209591683 EUDAMED08809209592321 EUDAMED
- 510(k) Number
- K141483 FDA UDI
- FDA Product Code
- MNW FDA UDI
- EMDN Code
- Z12040104 EQUIPMENT FOR DIAGNOSIS OF THE BIOELECTRIC FUNCTIONAL STATE EUDAMED
- GMDN Term
- Bioelectrical body composition analyser FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2770 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
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
Yes
FDA UDI
InBody580 by InBody Co., Ltd. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 880920959R6ZP | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- InBody Co., Ltd.
- EUDAMED SRN
- KR-MF-000011833
- Authorised Representative
- InBody Europe B.V. NL-AR-000011789
Sources (3)
- EUDAMED a6df1e1a-d51c-4ea5-ba6a-66a8ddd3f82c 61 fields · synced Jul 14, 2026
- FDA UDI b5b1f982-09fd-4c7c-84f8-6daffa6edfed 36 fields · synced May 30, 2026
- EUDAMED 19346998-38bb-42d0-842e-f496f248d26d 61 fields · synced Jul 11, 2026