Identity
- Trade Name
- InBody970S EUDAMED
- Device Name
- ANALYZER, BODY COMPOSITION EUDAMED
- Model / Reference
- InBody970S EUDAMEDU9 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809209592253 EUDAMED
- Basic UDI-DI
- 880920959U929 EUDAMED
- Direct Marketing DI
- 08809209592253 EUDAMED
- EMDN Code
- Z12040104 EQUIPMENT FOR DIAGNOSIS OF THE BIOELECTRIC FUNCTIONAL STATE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
InBody970S by InBody Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 880920959U929 | 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 (1)
- EUDAMED 35ae5152-cdb8-404d-a179-3ae196092cf7 61 fields · synced Jun 17, 2026