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BBLOVE Arm Blood Pressure Monitor
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref AES-U392
Identity
- Trade Name
- BBLOVE Arm Blood Pressure Monitor EUDAMEDFDA UDI
- Generic Name
- Automatic-inflation electronic sphygmomanometer, portable, arm/wrist FDA UDI
- Device Name
- Arm Blood Pressure Monitor EUDAMED
- Model / Reference
- AES-U392 EUDAMEDAES-U392-A FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06953775633345 EUDAMEDFDA UDI
- Basic UDI-DI
- 69537756U111UU EUDAMED
- 510(k) Number
- K231050 FDA UDI
- FDA Product Code
- DXN FDA UDI
- EMDN Code
- Z1203020302 NON–INVASIVE BLOOD PRESSURE MONITORING INSTRUMENTS EUDAMED
- GMDN Term
- Automatic-inflation electronic sphygmomanometer, portable, arm/wrist FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1130 FDA UDI
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
BBLOVE Arm Blood Pressure Monitor by Alicn Medical Shenzhen, Inc — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69537756U111UU | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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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 750bfa6c-8134-4f84-b72a-01578cfd3cbb 61 fields · synced Oct 6, 2026
- FDA UDI 94b938ed-4801-4dbb-811c-244cf5dea733 33 fields · synced May 30, 2026