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M1 EasyFit (HEM-7920-FLE)
EUDAMEDClass IIa (EU MDR)
Ref HEM-7920-FLEOModel HEM-7920-FLE
Identity
- Trade Name
- X1 EasyFit (HEM-7920-FLEO) EUDAMED
- Device Name
- M1 EasyFit (HEM-7920-FLE) EUDAMED
- Model / Reference
- HEM-7920-FLE EUDAMEDHEM-7920-FLEO EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04015672114661 EUDAMED
- Basic UDI-DI
- 4015672114655M EUDAMED
- Direct Marketing DI
- 04015672114661 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 8b1f7fed-a30a-4a23-b181-37ad1146e91e 61 fields · synced Oct 6, 2026
- EUDAMED 0e09b449-2ad3-4c23-8c71-6f0513f62edb 61 fields · synced Jul 28, 2026