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X2 Smart (HEM-7143T2-ESL)
EUDAMEDClass IIa (EU MDR)
Ref HEM-7143T2-ESLRef HEM-7146T2-ESL
Identity
- Trade Name
- X2 Smart (HEM-7143T2-ESL) EUDAMED
- Device Name
- X2 Smart EUDAMEDX2 Smart+ EUDAMED
- Model / Reference
- HEM-7143T2-ESL EUDAMEDHEM-7146T2-ESL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04015672113053 EUDAMED04015672114005 EUDAMED
- Basic UDI-DI
- 4015672113054W EUDAMED4015672114004R 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
X2 Smart (HEM-7143T2-ESL) 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 | 4015672113054W | 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 0c8d2976-2029-4775-89c5-7101757f488a 61 fields · synced Oct 6, 2026
- EUDAMED 8ec2aae6-1359-4278-b18d-b44c8f4d87a2 61 fields · synced May 17, 2026