Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016864576

FEI Number

3016864576

Entity Name

SUZHOU MELODICARE MEDICAL TECHNOLOGY CO., LTD

City/State/Country

Suzhou Jiangsu, CN

Establishment Address

Room 301, Building F2, No. 32 Hongxi road, Suzhou high-tech zone,Jiangsu province., Suzhou Jiangsu 215000, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Suzhou Melodicare Medical Technology Co., Ltd (Owner Number: 10069005)

Owner / Operator Contact Address

Building Room 301, no. 32 Hongxi road, Suzhou high-tech zone, Suzhou, CN-JS 215151, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K191667

PMA Number

N/A

All Registered Proprietary Names

Infrared Thermometer, model Breeze-20 Infrared Thermometer, model Breeze Electronic Stethoscope,model:iSteso-D2 Electronic Stethoscope,model:smartho-D2

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	2020-04-11
DQD	Stethoscope, Electronic	Cardiovascular	Class 2	870.1875	2021-04-23

Official Correspondent

Fay Zou

US Agent Details

Roy Zhang Business: RGLM Consulting LLC Email: admin@rglm-fda.com Phone: (425) 2364274

Related Public Records

Same Entity

Suzhou Melodicare Medical Technology 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

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 3016864576. Last updated year: 2026. Please use registration number 3016864576 when referencing this establishment in official correspondence.