Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009889471

FEI Number

3009889471

Entity Name

ALICN MEDICAL SHENZHEN, INC

City/State/Country

Shenzhen Guangdong, CN

Establishment Address

Room 301, Building D, Chaojie Industrial Park, No. 1 Guanghui Road, Jinsha Community, Kengzi Street, Pingshan District,, Shenzhen Guangdong 518122, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Alicn Medical Shenzhen, Inc (Owner Number: 10045880)

Owner / Operator Contact Address

Room 301, Building D, Chaojie Industrial Park, No. 1 Guanghui Road, Jinsha Community,Kengzi Street, Pingshan District, Shenzhen, CN-GD 518122, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K232338

PMA Number

N/A

All Registered Proprietary Names

Infrared Thermometer, Models of AET-R612W, AET-R612G, AET-R612P, AET-R612A, AET-R612B, AET-R612C Arm Blood Pressure Monitor, models of AES-U112, AES-U122, AES-U132, AES-U312, AES-U322, AES-U332 Electronic Thermometer, models of AET-F101,AET-F221,AET-F231,AET-F241 Arm Blood Pressure Monitor, models of AES-U511, AES-U521, AES-U531, AES-U532, AES-U572, AES-U611, AES-U621, AES-U631 Arm Blood Pressure Monitor, models of AES-U211, AES-U212, AES-U213, AES-U214 Arm Blood Pressure Monitor, models of AES-U512, AES-U522, AES-U612, AES-U622, AES-U632 Arm Blood Pressure Monitor, models of AES-U261 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-U311, AES-U321, AES-U331, AES-U341, AES-U351, AES-U361 Infrared Thermometer, Models of AET-R1B1,AET-R161,AET-R171,AET-R1D1,AET-R1D2,AET-R1F1,AET-R701,AET-R711 Infrared Thermometer, Models of AET-R721,AET-R731,AET-R1B6 Infrared Thermometer, models of AET-R101, AET-R1A2, AET-R151, AET-R1A3, AET-R1A6, AET-R1C1 Infrared Thermometer, models of AET-R811, AET-R832, AET-R834, AET-R842, AET-R852, AET-R862 Electronic Thermometer, models of AET-F344, AET-F345, AET-F346, AET-F354, AET-F355, AET-F356 Electronic Thermometer, models of AET-F371, AET-F372, AET-F373, AET-F381, AET-F382, AET-F383 Electronic Thermometer, models of AET-F331, AET-F332, AET-F333, AET-F361, AET-F362, AET-F363

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2023-06-08
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2023-09-10
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2022-05-15
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2022-10-18
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2021-10-28
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2022-05-08
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2022-01-07
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2023-12-24

Official Correspondent

Renxiong Huang

US Agent Details

Hector Matos Business: Retro Consultants, LLC Email: drugs@fdaregistrationassistance.com Phone: (928) 2758333

Related Public Records

Same Entity

Alicn Medical Shenzhen, Inc

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K010462	Avita Corporation	AVITA PICCOLO/EXATO INFARED EAR THERMOMETER (TS2 & TS4 SERIES)	2001-04-11
K760421	Arbrook Mfg. Corp.	THERMOMETER, SURVALENT-ELECTRONIC	1976-08-23
K813409	Yellow Springs Instrument Co., Inc.	MODEL 2100 DUAL-DISPLAY TELE-THERMOMETER	1981-12-18
K830039	Science Development Corp.	SDC RECTAL TEMP. PROBE PRODUCT #1020	1983-02-23
K842199	Sharp Electronics Corp.	ELEC. DIGITAL THERMOMETER MT-20 & 30	1984-07-18

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0032-2025	MEDLINE INDUSTRIES, LP Northfield	2	MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001
Z-0033-2025	MEDLINE INDUSTRIES, LP Northfield	2	MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001U.
Z-0034-2025	MEDLINE INDUSTRIES, LP Northfield	2	MEDLINE Automatic Digital Blood Pressure Monitor, REF MDS1001UT.

Similar Registrations

Registration Number	Establishment Name	Location
1062836	DIGICARE BIOMEDICAL TECHNOLOGY, INC.	BOYNTON BEACH, FL, US
3009487317	SHENZHEN JUZHONG TECHNOLOGY CO.,LTD	shenzhen Guangdong, CN
9681837	ME CENTER OF TERUMO CORP.	FUJINOMIYA Shizuoka, JP
3038761440	Corsano Health SA	Plan-les-Ouates Geneve, CH
3016595211	DYNAMIC EMS LTD	Dalgety Bay Fife, GB

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009889471. Last updated year: 2026. Please use registration number 3009889471 when referencing this establishment in official correspondence.