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Alphamed U19M
EUDAMEDClass IIa (EU MDR)
Ref 06953825910716Model U16H, U16L, U16P, U16W, U19M, U19R, U19S, and U19T
Identity
- Trade Name
- Alphamed U19M EUDAMED
- Device Name
- Wrist Watch Electronic Blood Pressure Monitor EUDAMED
- Model / Reference
- U16H, U16L, U16P, U16W, U19M, U19R, U19S, and U19T EUDAMED06953825910716 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06953825910716 EUDAMED
- Basic UDI-DI
- 69538259UWPM67 EUDAMED
- Direct Marketing DI
- 06953825910716 EUDAMED
- EMDN Code
- Z1203020501 NON–INVASIVE OSCILLOMETRIC BLOOD PRESSURE GAUGES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Northern Ireland 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
Alphamed U19M 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 | 69538259UWPM67 | 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 4ae05b0c-1693-44e6-b88f-7107ce591f73 61 fields · synced Aug 1, 2026