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L2N Wrist Electronic Blood Pressure Monitor
EUDAMEDClass IIa (EU MDR)
Ref U63IModel U62GH, U65H, U61GH, U60H, U61H, U62H, U63H, U67H, U68H, U60BH, U60K, U60B, U60CH, U60C, U60EH, U60E, U60I, U62I, U63I, U60GH, U60G
Identity
- Trade Name
- L2N Wrist Electronic Blood Pressure Monitor EUDAMED
- Device Name
- Wrist Electronic Blood Pressure Monitor EUDAMED
- Model / Reference
- U62GH, U65H, U61GH, U60H, U61H, U62H, U63H, U67H, U68H, U60BH, U60K, U60B, U60CH, U60C, U60EH, U60E, U60I, U62I, U63I, U60GH, U60G EUDAMEDU63I EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06953825911133 EUDAMED
- Basic UDI-DI
- 69538259UWBP53 EUDAMED
- Direct Marketing DI
- 06953825911133 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
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
L2N Wrist Electronic Blood Pressure Monitor by Shenzhen Urion Technology 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 | 69538259UWBP53 | 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 49b2c583-48a8-435b-ba1b-5f37f41a7c52 61 fields · synced Jun 19, 2026