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Hem-7380t1-Ebk
EUDAMEDClass IIa (EU MDR)
Ref HEM-7380T1-EBKModel M7 Intelli IT AFib
Identity
- Trade Name
- M7 Intelli IT AFib (HEM-7380T1-EBK) EUDAMED
- Device Name
- HEM-7380T1-EBK EUDAMED
- Model / Reference
- M7 Intelli IT AFib EUDAMEDHEM-7380T1-EBK EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04015672113923 EUDAMED
- Basic UDI-DI
- 4015672113925K 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-Ebk 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 | 4015672113925K | 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 2f54f2d2-26cc-4f79-9e12-f0ef6f34f00b 61 fields · synced Oct 6, 2026
- EUDAMED 5e35f8e5-dd19-44a4-b3a7-471e06bdfa7c 61 fields · synced Jul 12, 2026