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X2+ Connect (HEM-7188T1-LEO)
EUDAMEDClass IIa (EU MDR)
Ref HEM-7188T1-LEOModel HEM-7188-E
Identity
- Trade Name
- X2+ Connect (HEM-7188T1-LEO) EUDAMED
- Device Name
- X2+ Connect (HEM-7188T1-LEO) EUDAMEDM2 Essential (HEM-7188-E) EUDAMED
- Model / Reference
- HEM-7188T1-LEO EUDAMEDHEM-7188-E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04015672114296 EUDAMED
- Basic UDI-DI
- 4015672114295H EUDAMED40156721142559 EUDAMED
- Direct Marketing DI
- 04015672114296 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+ Connect (HEM-7188T1-LEO) 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 | 4015672114295H | 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 e5e6f4e7-43dd-4f96-adcb-6e7d7a426595 61 fields · synced Jun 18, 2026
- EUDAMED 499823eb-b518-4296-a30e-ec0aac553eca 61 fields · synced Jun 18, 2026