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Body Comp Monitor BF511 Blue (HBF-511B-E)
EUDAMEDClass I (EU MDR)
Ref HBF-511B-E
Identity
- Trade Name
- Body Comp Monitor BF511 Blue (HBF-511B-E) EUDAMED
- Device Name
- Body Comp Monitor BF511 Blue EUDAMED
- Model / Reference
- HBF-511B-E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04015672104051 EUDAMED
- Basic UDI-DI
- 4015672104054U EUDAMED
- EMDN Code
- Z12099001 BODY IMPEDANCE ANALYSERS EUDAMED
Classification
- Device Class
- Class I 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
Body Comp Monitor BF511 Blue (HBF-511B-E) by OMRON Healthcare Co., Ltd. — Class I — 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 | 4015672104054U | Class I | Active |
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Manufacturer
- Manufacturer
- OMRON Healthcare Co., Ltd.
- EUDAMED SRN
- JP-MF-000007213
- Authorised Representative
- OMRON Healthcare Europe B.V. NL-AR-000002683
Sources (1)
- EUDAMED 04485ad1-14ba-4c6d-a74c-80c3c8269406 61 fields · synced Oct 7, 2026