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Alphamed Upper Arm Electronic Blood Pressure Monitor
EUDAMEDClass IIa (EU MDR)
Ref U63IModel U80CH series, 80H series, U80M series, U80NH series, U81X series, U81RH series, U83Z series, U86E series, U90E series Total: 69 models
Identity
- Trade Name
- Alphamed Upper Arm Electronic Blood Pressure Monitor EUDAMED
- Device Name
- Upper Arm Electronic Blood Pressure Monitor EUDAMED
- Model / Reference
- U80CH series, 80H series, U80M series, U80NH series, U81X series, U81RH series, U83Z series, U86E series, U90E series Total: 69 models EUDAMEDU63I EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06953825911096 EUDAMED
- Basic UDI-DI
- 69538259UBP8K EUDAMED
- Direct Marketing DI
- 06953825911096 EUDAMED
- EMDN Code
- Z1203020501 NON–INVASIVE OSCILLOMETRIC BLOOD PRESSURE GAUGES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Sweden 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 Upper Arm 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 | 69538259UBP8K | 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 67667f2b-14aa-4bf6-9c83-45b6ac42f3a4 61 fields · synced Jul 9, 2026