Identity
- Trade Name
- Complete (HEM-7440T1-FLE) EUDAMED
- Device Name
- Complete (HEM-7440T1-FLE) EUDAMED
- Model / Reference
- HEM-7440T1-FLE EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04015672114531 EUDAMED
- Basic UDI-DI
- 4015672114535E EUDAMED
- Direct Marketing DI
- 04015672114531 EUDAMED
- EMDN Code
- Z1203020302 NON–INVASIVE BLOOD PRESSURE MONITORING INSTRUMENTS 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
Complete (HEM-7440T1-FLE) 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 | 4015672114535E | 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 (2)
- EUDAMED 67161be4-c577-42e0-b729-93bc7be3c612 61 fields · synced Jun 19, 2026
- EUDAMED ef00fe89-1f87-42fe-83fb-a9e08bcd673a 61 fields · synced Jun 19, 2026