Baymed Arm Blood Pressure Monitor AES-U111
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Identity
- Trade Name
- Baymed Arm Blood Pressure Monitor EUDAMEDBaymed Arm Blood Pressure Monitor FDA UDI
- Generic Name
- Automatic-inflation electronic sphygmomanometer, portable, arm/wrist FDA UDI
- Device Name
- Arm Blood Pressure Monitor EUDAMED
- Model / Reference
- AES-U111 EUDAMEDAES-U111-D FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06953775659352 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
- Spain EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
Yes
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
Yes
Expiration Date
No
Manufacturing Date
No
The Baymed Arm Blood Pressure Monitor is an active medical device designed to measure blood pressure. It functions as a diagnostic tool for monitoring cardiovascular health through arm-based readings.
This device is classified as Class IIa and is not sterile or implantable. It is manufactured by Alicn Medical Shenzhen, Inc and holds both FDA 510k and MDR authorizations. The unit is identified by reference code AES-U111 and is intended for standard use.
Frequently asked questions
Is the Baymed Arm Blood Pressure Monitor sterile?
No, the device is not sterile, as indicated by its technical specifications.
What is the regulatory status of this monitor?
The device is authorized under both FDA 510k and MDR regulatory frameworks.
Can this device be used for implantable applications?
No, the device is not implantable and is intended for external arm-based blood pressure monitoring.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Alicn Medical Shenzhen, Inc. AES-U111-D Baymed Arm Blood ..., Arm Blood Pressure Monitor 510(k) K180435 - FDA.report, System, Measurement, Blood-Pressure, Non-Invasive - RevMed, Alicn Medical Shenzhen, Inc. - RevMed Marketplace | Connecting ...
Authorization Coverage (2 countries)
Regulatory Authorizations
FDA_510K
FDA_510K
FDA_510K
FDA_510K
FDA_510K
FDA_510K
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K210563 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K221913 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K180435 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K212877 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K230649 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K231050 | Class IIa | Active |
| 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 (3)
- EUDAMED e9c28087-d5c8-44c8-a3ca-6f0780d162c8 61 fields · synced Oct 6, 2026
- FDA UDI 4da68f97-5d09-4c26-baba-644e4421742c 33 fields · synced May 30, 2026
- FDA 510(k) K210563 1 fields · synced May 18, 2026