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Hem-7380t1-Eosl
EUDAMEDClass IIa (EU MDR)
Ref HEM-7380T1-EOSLModel X7 Smart AFib Model M7 Intelli IT AFib
Identity
- Trade Name
- X7 Smart AFib (HEM-7380T1-EOSL) EUDAMED
- Device Name
- HEM-7380T1-EOSL EUDAMEDHEM-7380T1-EBK EUDAMED
- Model / Reference
- X7 Smart AFib EUDAMEDHEM-7380T1-EOSL EUDAMEDM7 Intelli IT AFib EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04015672113930 EUDAMED
- Basic UDI-DI
- 4015672113935M EUDAMED4015672113925K EUDAMED
- Direct Marketing DI
- 04015672113930 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
Hem-7380t1-Eosl 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 | 4015672113935M | 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 f19d605e-05ef-46f5-8694-d9a1ba2c3819 61 fields · synced Oct 6, 2026
- EUDAMED 168655f8-bc35-4bd3-89b6-7773139527ec 61 fields · synced Jul 22, 2026