Identity
- Trade Name
- M1 Basic (HEM-7090-E) EUDAMED
- Device Name
- M1 Basic (HEM-7090-E) EUDAMEDM2 Essential (HEM-7188-E) EUDAMED
- Model / Reference
- HEM-7090-E EUDAMEDHEM-7188-E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04015672114234 EUDAMED
- Basic UDI-DI
- 40156721142355 EUDAMED40156721142559 EUDAMED
- Direct Marketing DI
- 04015672114234 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
M1 Basic (HEM-7090-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 | 40156721142355 | 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 d00b33c6-bf03-4fa4-8326-ef61ffb316f0 61 fields · synced Jul 23, 2026
- EUDAMED 63ed9afa-88a9-46ab-8d8d-c28cdb7669c9 61 fields · synced Jul 23, 2026