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OMRON Connect
EUDAMEDClass IIa (EU MDR)
Ref OMRON ConnectModel OMRON connect US/CAN/EMEA
Identity
- Device Name
- OMRON Connect EUDAMED
- Model / Reference
- OMRON connect US/CAN/EMEA EUDAMEDOMRON Connect EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04015672113862 EUDAMED
- Basic UDI-DI
- 4015672113865Q EUDAMED
- EMDN Code
- Z12050392 ELECTROCARDIOGRAPHS - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Special Device Type
- Software 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
OMRON Connect 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 | 4015672113865Q | 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 (1)
- EUDAMED 78caf1d1-6028-4882-b311-a3c167721cfc 61 fields · synced Oct 7, 2026