Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015136472

FEI Number

3015136472

Entity Name

SHENZHEN FINICARE CO., LTD.

City/State/Country

Shenzhen Guangdong, CN

Establishment Address

201 and 301 of Building A22, Building A22 and A23, No.4 Industrial Park, Tantou Community, Songgang Street, Bao an District, Shenzhen Guangdong 518105, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Shenzhen Finicare Co., Ltd. (Owner Number: 10059798)

Owner / Operator Contact Address

201 and 301 of Building A22, Building A22 and A23, No.4 Industrial Park, Tantou Community, Songgang Street, Bao an District, Shenzhen, CN-GD 518105, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K252769

PMA Number

N/A

All Registered Proprietary Names

Infrared thermometer FC-IR101 Infrared thermometer FC-IR400 Infrared thermometer FC-IR100 Infrared thermometer FC-IR200 Infrared thermometer FC-IR300 Non-contact Forehead Infrared Thermometer FC-IR205 Non-contact Forehead Infrared Thermometer FC-IR202 Non-contact Forehead Infrared Thermometer FC-IR206 Non-contact Forehead Infrared Thermometer FC-IR209 Non-contact Forehead Infrared Thermometer FC-IR207 Non-contact Forehead Infrared Thermometer FC-IR2000 Electronic Thermometer FC-TM131 Infrared Thermometer FC-IR1030 Electronic Thermometer FC-TM112 Infrared Thermometer FC-IR1011 Electronic Thermometer FC-TM120 Infrared Thermometer FC-IR1010 Electronic Thermometer FC-TM113 Infrared Thermometer FC-IR1013 Infrared Thermometer FC-IR117 Electronic Thermometer FC-TM100 Infrared Thermometer FC-IR105 Infrared Thermometer FC-IR109 Infrared Thermometer FC-IR211 Infrared Thermometer FC-IR301 Infrared Thermometer FC-IR2001 Electronic Thermometer FC-TM111 Infrared Thermometer FC-IR213 Electronic Thermometer FC-TM101 Infrared Thermometer FC-IR115 Infrared Thermometer FC-IR208 Electronic Thermometer FC-TM132 Infrared Thermometer FC-IR111 Electronic Thermometer FC-TM130 Infrared Thermometer FC-IR110 Electronic Thermometer FC-TM110 Infrared Thermometer FC-IR106 Infrared Thermometer FC-IR3010 Electronic Thermometer FC-TM121 Infrared Thermometer FC-IR1012 Infrared Thermometer FC-IR112 Infrared Thermometer FC-IR215 Infrared Thermometer FC-IR210 Infrared Thermometer FC-IR116 Infrared Thermometer FC-IR1020 FC-BP200 Wrist Electronic Blood Pressure Monitor FC-BP221 Wrist Electronic Blood Pressure Monitor FC-BP220 Wrist Electronic Blood Pressure Monitor FC-BP210 Wrist Electronic Blood Pressure Monitor FC-BP201 Wrist Electronic Blood Pressure Monitor FC-BP211 Wrist Electronic Blood Pressure Monitor FC-BP110 Upper Arm Electronic Blood Pressure Monitor FC-BP112 Upper Arm Electronic Blood Pressure Monitor FC-BP111 Upper Arm Electronic Blood Pressure Monitor FC-BP102 Upper Arm Electronic Blood Pressure Monitor FC-BP101 Upper Arm Electronic Blood Pressure Monitor FC-BP100 Upper Arm Electronic Blood Pressure Monitor One Step® FC-BP130 Upper Arm Electronic Blood Pressure Monitor FC-BP103 Upper Arm Electronic Blood Pressure Monitor FC-BP106 Upper Arm Electronic Blood Pressure Monitor FC-BP130 Upper Arm Electronic Blood Pressure Monitor FC-BP121 Upper Arm Electronic Blood Pressure Monitor FC-BP120 Upper Arm Electronic Blood Pressure Monitor ZOMEE FC-BP120 Upper Arm Electronic Blood Pressure Monitor FC-BP131 Upper Arm Electronic Blood Pressure Monitor VitalPulse FC-BP121 Upper Arm Electronic Blood Pressure Monitor FC-BP113 Upper Arm Electronic Blood Pressure Monitor VitalPulse FC-BP131 Upper Arm Electronic Blood Pressure Monitor FC-BP127 Upper Arm Electronic Blood Pressure Monitor FC-BP123 Upper Arm Electronic Blood Pressure Monitor FC-BP126 Upper Arm Electronic Blood Pressure Monitor FC-BP107 Upper Arm Electronic Blood Pressure Monitor FC-BP125 Upper Arm Electronic Blood Pressure Monitor FC-BP116 Upper Arm Electronic Blood Pressure Monitor

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	2019-02-24
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2025-02-27
SDV	Clinical Electronic Thermometer	General Hospital	Class 2	880.2910	2025-06-29
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2023-09-26
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2022-06-05
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2024-10-24
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2025-11-17

Official Correspondent

Frank He

US Agent Details

Robin Zhang Business: CTI US lnc. Email: robin.zhang@cti-cert.com Phone: (313) 2885666

Related Public Records

Same Entity

Shenzhen Finicare Co., Ltd.

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 3015136472. Last updated year: 2026. Please use registration number 3015136472 when referencing this establishment in official correspondence.