← Back to catalogue
E3 Intense (HV-F021-ESL)
EUDAMEDClass IIa (EU MDR)
Ref E3 Intense (HV-F021-ESL)Model HV-F021-ES
Identity
- Trade Name
- E3 Intense (HV-F021-ESL) EUDAMED
- Device Name
- E3 Intense EUDAMED
- Model / Reference
- HV-F021-ES EUDAMEDE3 Intense (HV-F021-ESL) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04015672109537 EUDAMED
- Basic UDI-DI
- 4015672109535Y EUDAMED
- EMDN Code
- Z12062899 NEUROMUSCULAR STIMULATION EQUIPMENT - OTHER 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
E3 Intense (HV-F021-ESL) by OMRON Healthcare 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 | 4015672109535Y | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- OMRON Healthcare Co., Ltd.
- EUDAMED SRN
- JP-MF-000007213
- Authorised Representative
- OMRON Healthcare Europe B.V. NL-AR-000002683
Sources (1)
- EUDAMED fdcbacdc-09c7-4686-a68b-10d6d0ea2063 61 fields · synced Jun 20, 2026