Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3044854644

FEI Number

3044854644

Entity Name

HOMEDICA LIMITED

City/State/Country

KL, HK

Establishment Address

UNIT 3,6/F KAM HON INDUSTRIAL BUILDING 8 WANG KWUN ROAD KOWLOON BAY, KL 999073, HK

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

HOMEDICA LIMITED (Owner Number: 10095486)

Owner / Operator Contact Address

Room 2106, Xingyao Building, Binjiang District, Hangzhou, CN-ZJ 310051, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K243136

PMA Number

N/A

All Registered Proprietary Names

Goodbaby, Thermometer, model FC-IR100 Goodbaby, Thermometer, model FC-IR202 Goodbaby, Thermometer, model FC-IR2000

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	2026-03-19
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2026-03-19

Official Correspondent

Sherry Zhang

US Agent Details

Simin Lin Email: simin_lin123@126.com Phone: (415) 6026843

Related Public Records

Same Entity

HOMEDICA LIMITED

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

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 3044854644. Last updated year: 2026. Please use registration number 3044854644 when referencing this establishment in official correspondence.