Identity
- Device Name
- HEM-FL33 EUDAMED
- Model / Reference
- HEM-FL33-CAP EUDAMEDHEM-FL33-CE EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04975479499418 EUDAMED04015672114678 EUDAMED
- Basic UDI-DI
- 497547949941QK EUDAMED4015672114675R EUDAMED
- EMDN Code
- Z1203020302 NON–INVASIVE BLOOD PRESSURE MONITORING INSTRUMENTS 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Hem-Fl33 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 | 497547949941QK | 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 (2)
- EUDAMED cabc26b7-f27e-4acc-a1ed-956c315722ea 61 fields · synced Oct 5, 2026
- EUDAMED 8e64498d-1c7b-4112-a5fb-3205486fe7f6 61 fields · synced Jul 16, 2026