Identity
- Trade Name
- M1 EasyFit (HEM-7920-FLE) EUDAMED
- Device Name
- M1 EasyFit (HEM-7920-FLE) EUDAMED
- Model / Reference
- HEM-7920-FLE EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04015672114654 EUDAMED
- Basic UDI-DI
- 4015672114655M EUDAMED
- Direct Marketing DI
- 04015672114654 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 EasyFit (HEM-7920-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 | 4015672114655M | 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 45734cf2-1f46-4fa5-beb4-457d48aa271d 61 fields · synced Jun 20, 2026
- EUDAMED 7bf38d07-5301-4a91-9224-652a9632818a 61 fields · synced Jun 20, 2026