Identity
- Trade Name
- Hauwute EUDAMED
- Device Name
- Arm Blood Pressure Monitor EUDAMED
- Model / Reference
- AES-U612 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06953775662352 EUDAMED06953775662567 EUDAMED
- Basic UDI-DI
- 69537756U111UU EUDAMED
- EMDN Code
- Z1203020302 NON–INVASIVE BLOOD PRESSURE MONITORING INSTRUMENTS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- 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
Hauwute by Alicn Medical Shenzhen, Inc — 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 | 69537756U111UU | Class IIa | Active |
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Manufacturer
- Manufacturer
- Alicn Medical Shenzhen, Inc
- EUDAMED SRN
- CN-MF-000001920
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (2)
- EUDAMED 71b97961-987e-4652-aa44-873a43e14653 61 fields · synced Aug 2, 2026
- EUDAMED 0972874c-3d04-404e-a733-8bd88028607b 61 fields · synced Jul 9, 2026