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M1 Basic (HEM-7090-LE)
EUDAMEDClass IIa (EU MDR)
Ref HEM-7090-LEModel HEM-7188-E
Identity
- Trade Name
- M1 Basic (HEM-7090-LE) EUDAMED
- Device Name
- M1 Basic (HEM-7090-LE) EUDAMEDM2 Essential (HEM-7188-E) EUDAMED
- Model / Reference
- HEM-7090-LE EUDAMEDHEM-7188-E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04015672114241 EUDAMED
- Basic UDI-DI
- 40156721142457 EUDAMED40156721142559 EUDAMED
- Direct Marketing DI
- 04015672114241 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-LE) 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 | 40156721142457 | 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 a4e09175-282f-4dae-b4ae-4719057c5c26 61 fields · synced Jul 15, 2026
- EUDAMED d3adfd9d-ac0a-419d-86bb-808fb6ae5938 61 fields · synced Jul 15, 2026