FDA device listing
Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MW1-4B
FDA device listing 2033111377 · MICROLIFE CORP.
Key facts
| Proprietary names | Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MW1-4B |
|---|---|
| Owner/operator | MICROLIFE CORP. |
| Owner/operator number | 8020605 |
| Premarket submissions | K153077 |
| Product codes | DXN |
| Device names | DXN - System, Measurement, Blood-Pressure, Non-Invasive |
| Device class | Class II |
| Classification regulations (21 CFR) | 870.1130 |
| Review panels | Cardiovascular |
| Registered establishments | MICROLIFE CORP., ONBO ELECTRONIC (SHENZHEN) CO. LTD., ONFU electronics Co., LTD. |
| Establishment registrations | 8020605, 9680225, 3016867013 |
| FEI numbers | 3003010579, 3003079707, 3016867013 |
| Establishment operations | Contract Manufacturer, Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database