Identity
- Trade Name
- InBody M20 EUDAMEDInBody FDA UDI
- Generic Name
- Bioelectrical body composition analyser FDA UDI
- Device Name
- ANALYZER, BODY COMPOSITION EUDAMEDBody Composition Analyzer FDA UDI
- Model / Reference
- InBody M20 EUDAMEDFDA UDIP5 EUDAMED
- Description
- Body Composition Analyzer FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809209590969 EUDAMEDFDA UDI
- Basic UDI-DI
- 880920959P5ZF EUDAMED
- Direct Marketing DI
- 08809209590969 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
- 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
InBody M20 by InBody Co., Ltd. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K200560 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K200442 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 880920959P5ZF | Class IIa | Active |
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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 1a79befe-7128-49b5-9171-bce62f9a509e 61 fields · synced Jul 14, 2026
- FDA UDI 2e3a6c53-a3ba-4aa7-8a1f-2055c53bac8d 36 fields · synced May 30, 2026
- FDA 510(k) K200560 1 fields · synced May 18, 2026