Identity
- Trade Name
- H20/H20B EUDAMEDInBody FDA UDI
- Generic Name
- Bioelectrical body composition analyser FDA UDI
- Device Name
- ANALYZER, BODY COMPOSITION EUDAMEDBody Composition Analyzer FDA UDI
- Model / Reference
- InBody H20B EUDAMEDFDA UDIG5 EUDAMED
- Description
- Body Composition Analyzer FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809209590280 EUDAMEDFDA UDI
- Basic UDI-DI
- 880920959G5YL EUDAMED
- Direct Marketing DI
- 08809209590280 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
H20/H20b 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 | 880920959G5YL | 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 (2)
- EUDAMED a2b3bc1e-c776-49c2-8128-3da5dde5e3e9 61 fields · synced Jun 19, 2026
- FDA UDI 99188b98-45da-456b-9a90-3c91ac16ced2 36 fields · synced May 29, 2026