Identity
- Trade Name
- Autonomie et Bien être EUDAMED
- Device Name
- Wrist Electronic Blood Pressure Monitor EUDAMED
- Model / Reference
- U60EH EUDAMED06953825909048 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06953825909048 EUDAMED
- Basic UDI-DI
- B-06953825909048 EUDAMED
- EMDN Code
- Z1203020501 NON–INVASIVE OSCILLOMETRIC BLOOD PRESSURE GAUGES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Autonomie et Bien être by Shenzhen Urion Technology Co., Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06953825909048 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shenzhen Urion Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000018740
- Authorised Representative
- Wellkang Ltd XI-AR-000001836
Sources (1)
- EUDAMED 67a03070-f006-49d5-92f9-05b0993fc02e 61 fields · synced Jun 18, 2026