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BBLOVE Arm Blood Pressure Monitor
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref AES-U372Ref AES-U112Ref AES-U181
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-U372 EUDAMEDAES-U112 EUDAMEDAES-U181 EUDAMEDAES-U181-I FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06953775660143 EUDAMED06953775660129 EUDAMED06953775600071 EUDAMEDFDA UDI
- Basic UDI-DI
- 69537756U111UU EUDAMED
- 510(k) Number
- K180435 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
- Poland EUDAMEDIreland 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
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 (4)
- EUDAMED ffeecec1-6fed-4696-862f-421ea503bfd5 61 fields · synced Oct 6, 2026
- EUDAMED 849ed032-c8e1-41c8-ad87-fe40f451500d 61 fields · synced May 18, 2026
- EUDAMED 3abec780-c45a-425d-8421-47105508e981 61 fields · synced May 19, 2026
- FDA UDI 2d97f853-6d23-43e0-9ff0-f9efbcd2eba3 33 fields · synced May 30, 2026