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M2+ Connect (HEM-7188T1-LE)
EUDAMEDClass IIa (EU MDR)
Ref HEM-7188T1-LEModel HEM-7188-E
Identity
- Trade Name
- M2+ Connect (HEM-7188T1-LE) EUDAMED
- Device Name
- M2+ Connect (HEM-7188T1-LE) EUDAMEDM2 Essential (HEM-7188-E) EUDAMED
- Model / Reference
- HEM-7188T1-LE EUDAMEDHEM-7188-E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04015672114289 EUDAMED
- Basic UDI-DI
- 4015672114285F EUDAMED40156721142559 EUDAMED
- Direct Marketing DI
- 04015672114289 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
M2+ Connect (HEM-7188T1-LE) 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 | 4015672114285F | 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 ec89cfbe-6acc-4fcf-a15c-601dcfbe52ab 61 fields · synced Oct 6, 2026
- EUDAMED 29c8afa7-abdb-49cb-a4b2-1dc751c6f193 61 fields · synced Jul 9, 2026