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X3 Comfort AFib (HEM-7196-FLEO)
EUDAMEDClass IIa (EU MDR)
Ref HEM-7196-FLEOModel M7 Intelli IT AFib
Identity
- Trade Name
- X3 Comfort AFib (HEM-7196-FLEO) EUDAMED
- Device Name
- X3 Comfort AFib (HEM-7196-FLEO) EUDAMEDHEM-7380T1-EBK EUDAMED
- Model / Reference
- HEM-7196-FLEO EUDAMEDM7 Intelli IT AFib EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04015672114326 EUDAMED
- Basic UDI-DI
- 40156721143256 EUDAMED4015672113925K EUDAMED
- Direct Marketing DI
- 04015672114326 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
X3 Comfort AFib (HEM-7196-FLEO) 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 | 40156721143256 | 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 9455801b-88c4-40e8-93c4-a0dafbdacebc 61 fields · synced Jul 11, 2026
- EUDAMED e647e736-3e92-4a34-ad4c-cca077e2cebc 61 fields · synced Jul 11, 2026