Identity
- Trade Name
- BF212 (HBF-212-EW) EUDAMED
- Device Name
- BF212 EUDAMED
- Model / Reference
- HBF-212-EW EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04015672107038 EUDAMED
- Basic UDI-DI
- 40156721070357 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
Bf212 (hbf-212-Ew) 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 | 40156721070357 | 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 535bdfbb-2ee7-4414-abe0-52e08848cee5 61 fields · synced Jun 18, 2026