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M4 Connect AFib (HEM-7196T1-FLE)
EUDAMEDClass IIa (EU MDR)
Ref HEM-7196T1-FLEModel M7 Intelli IT AFib
Identity
- Trade Name
- M4 Connect AFib (HEM-7196T1-FLE) EUDAMED
- Device Name
- M4 Connect AFib (HEM-7196T1-FLE) EUDAMEDHEM-7380T1-EBK EUDAMED
- Model / Reference
- HEM-7196T1-FLE EUDAMEDM7 Intelli IT AFib EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04015672114333 EUDAMED
- Basic UDI-DI
- 40156721143358 EUDAMED4015672113925K EUDAMED
- Direct Marketing DI
- 04015672114333 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
M4 Connect AFib (HEM-7196T1-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 | 40156721143358 | 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 c50d367c-e5d0-453a-bfdd-017596484fea 61 fields · synced Oct 5, 2026
- EUDAMED 4b5503da-9a1b-4839-88cd-5b4156cac8ae 61 fields · synced Oct 5, 2026