Identity
- Trade Name
- M2 Essential (HEM-7188-E) EUDAMED
- Device Name
- M2 Essential (HEM-7188-E) EUDAMED
- Model / Reference
- HEM-7188-E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04015672114258 EUDAMED
- Basic UDI-DI
- 40156721142559 EUDAMED
- Direct Marketing DI
- 04015672114258 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
M2 Essential (HEM-7188-E) 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 | 40156721142559 | Class IIa | 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 275ad80f-547d-49e7-b7ea-6bf6c441226b 61 fields · synced Oct 6, 2026
- EUDAMED 2545d887-b5ee-4125-95fe-7bb4218e9389 61 fields · synced Jul 10, 2026