Identity
- Trade Name
- InBody970 EUDAMEDInBody FDA UDI
- Generic Name
- Bioelectrical body composition analyser FDA UDI
- Device Name
- ANALYZER, BODY COMPOSITION EUDAMEDBody composition analyzer which is not intended to diagnose or treat any medical condition. FDA UDI
- Model / Reference
- InBody970 EUDAMEDFDA UDII4 EUDAMED
- Description
- Body composition analyzer which is not intended to diagnose or treat any medical condition. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809209590846 EUDAMEDFDA UDI
- Basic UDI-DI
- 880920959I4YQ EUDAMED
- Direct Marketing DI
- 08809209590846 EUDAMED
- FDA Product Code
- PUH 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
Yes
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
InBody970 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 | 880920959I4YQ | 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 2247655f-0c06-4c0e-9e72-8d09b30395f3 61 fields · synced Jul 9, 2026
- FDA UDI 24579168-53f1-44a3-92e6-56b35294c752 34 fields · synced May 30, 2026