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L2n
EUDAMEDClass IIa (EU MDR)
Ref 06953825909208Model U81QRef 06953825909505Model U87ERef 06953825909215Model U63IRef 06953825910297Model U80MRef 06953825911140
Identity
- Trade Name
- L2N EUDAMED
- Device Name
- Upper Arm Electronic Blood Pressure Monitor EUDAMEDWrist Electronic Blood Pressure Monitor EUDAMED
- Model / Reference
- U81Q EUDAMED06953825909208 EUDAMEDU87E EUDAMED06953825909505 EUDAMEDU63I EUDAMED06953825909215 EUDAMEDU80M EUDAMED06953825910297 EUDAMED06953825911140 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06953825909208 EUDAMED06953825909505 EUDAMED06953825909215 EUDAMED06953825910297 EUDAMED06953825911140 EUDAMED
- Basic UDI-DI
- B-06953825909208 EUDAMEDB-06953825909505 EUDAMEDB-06953825909215 EUDAMEDB-06953825910297 EUDAMEDB-06953825911140 EUDAMED
- EMDN Code
- Z1203020599 NON-INVASIVE BLOOD PRESSURE GAUGES - OTHER EUDAMEDZ1203020501 NON–INVASIVE OSCILLOMETRIC BLOOD PRESSURE GAUGES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France EUDAMEDNorthern Ireland 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
L2n 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-06953825909208 | 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 (5)
- EUDAMED b3377458-c12a-4e00-95f1-9e07eb9e2758 61 fields · synced Aug 2, 2026
- EUDAMED 520770fe-152f-41b7-950a-2564b29ff0c7 61 fields · synced May 16, 2026
- EUDAMED dbb0bc3a-cd13-4370-a44e-11aa9763f570 61 fields · synced May 17, 2026
- EUDAMED 11487dfd-cb81-4165-a093-b888a4b1e513 61 fields · synced May 18, 2026
- EUDAMED c9100aad-4c14-4b9d-b494-9656c642a425 61 fields · synced Aug 2, 2026