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Intelli Cuff HEM-FL31 (HEM-FL31-E)
EUDAMEDClass I (EU MDR)
Ref Intelli Cuff HEM-FL31 (HEM-FL31-E)Model HEM-FL31-E
Identity
- Trade Name
- Intelli Cuff HEM-FL31 (HEM-FL31-E) EUDAMED
- Device Name
- Intelli Cuff HEM-FL31 EUDAMED
- Model / Reference
- HEM-FL31-E EUDAMEDIntelli Cuff HEM-FL31 (HEM-FL31-E) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04015672109056 EUDAMED
- Basic UDI-DI
- 4015672109055M EUDAMED
- EMDN Code
- Z1203020302 NON–INVASIVE BLOOD PRESSURE MONITORING INSTRUMENTS EUDAMED
Classification
- Device Class
- Class I 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Intelli Cuff HEM-FL31 (HEM-FL31-E) by OMRON Healthcare Co., Ltd. — Class I — 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 | 4015672109055M | Class I | 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 (1)
- EUDAMED 647893cb-a3a2-4b89-9f8e-2ef889fdff67 61 fields · synced Jun 18, 2026