Data / Medical devices / China / Alicn Medical Shenzhen, Inc
Alicn Medical Shenzhen, Inc: FDA-registered device maker in Shenzhen Guangdong, China, 9 510(k) clearances
Alicn Medical Shenzhen, Inc is registered with the FDA (registration 3009889471) in Shenzhen Guangdong, China. It lists 2 device types. The FDA files 9 510(k) clearances under its listings, the newest dated December 22, 2023. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3009889471
- Address
- Room 301, Building D, Chaojie Industrial Park, No. 1 Guanghui Road Jinsha Community, Kengzi Street, Pingshan District, Shenzhen Guangdong, China, 518122
- Owner or operator
- Alicn Medical Shenzhen, Inc (10045880)
- Roles
- Manufacturer
- First device listed
- October 28, 2021
- Registered through
- 2027
- Brand names listed
- Arm Blood Pressure Monitor, models of AES-U111, AES-U121, AES-U131, AES-U141, AES-U151, AES-U161, AES-U181, AES-U191, Arm Blood Pressure Monitor, models of AES-U112, AES-U122, AES-U132, AES-U312, AES-U322, AES-U332, Arm Blood Pressure Monitor, models of AES-U211, AES-U212, AES-U213, AES-U214, Arm Blood Pressure Monitor, models of AES-U231, AES-U371, AES-U372, AES-U373, AES-U381, AES-U382, Arm Blood Pressure Monitor, models of AES-U261, Arm Blood Pressure Monitor, models of AES-U311, AES-U321, AES-U331, AES-U341, AES-U351, AES-U361, Arm Blood Pressure Monitor, models of AES-U391, AES-U392, AES-U393, AES-U301, AES-U302, Arm Blood Pressure Monitor, models of AES-U511, AES-U521, AES-U531, AES-U532, AES-U572, AES-U611, AES-U621, AES-U631 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Continuous Measurement Thermometer | FLL | 2 | Manufacturer | accessdata.fda.gov |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 22, 2023 | K232338 | Electronic Thermometer, Model: AET-F331, AET-F332, AET-F333, AET-F344, AET-F345, AET-F346, AET-F354, AET-F355, AET-F356, AET-F361, AET-F362, AET-F363, AET-F371, AET-F372, AET-F373, AET-F381, AET-F382, AET-F383 | FLL | Substantially Equivalent | Alicn Medical Shenzhen, Inc. | accessdata.fda.gov |
| October 11, 2023 | K231050 | Arm Blood Pressure Monitor | DXN | Substantially Equivalent | Alicn Medical Shenzhen, Inc. | accessdata.fda.gov |
| September 7, 2023 | K230649 | Arm Blood Pressure Monitor | DXN | Substantially Equivalent | Alicn Medical Shenzhen, Inc. | accessdata.fda.gov |
| June 7, 2023 | K222248 | Infrared Thermometer | FLL | Substantially Equivalent | Alicn Medical Shenzhen, Inc. | accessdata.fda.gov |
| October 12, 2022 | K221913 | Arm Blood Pressure Monitor | DXN | Substantially Equivalent | Alicn Medical Shenzhen, Inc. | accessdata.fda.gov |
| May 12, 2022 | K210937 | Electronic Thermometer, Model: AET-F101, AET-F221, AET-F231, AET-F241 | FLL | Substantially Equivalent | Alicn Medical Shenzhen, Inc. | accessdata.fda.gov |
| May 5, 2022 | K210565 | Infrared Thermometer, Model: AET-R1B1, AET-R161, AET-R171, AET-R1D1, AET-R1D2, AET-R1F1, AET-R701, AET-R711 | FLL | Substantially Equivalent | Alicn Medical Shenzhen, Inc. | accessdata.fda.gov |
| January 7, 2022 | K210564 | Infrared Thermometer | FLL | Substantially Equivalent | Alicn Medical Shenzhen, Inc. | accessdata.fda.gov |
| October 15, 2021 | K210563 | Arm Blood Pressure Monitor | DXN | Substantially Equivalent | Alicn Medical Shenzhen, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Continuous Measurement Thermometer
- All makers of System, Measurement, Blood-Pressure, Non-Invasive
Updated December 22, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.