Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009518322

FEI Number

3009518322

Entity Name

KANG ZE INDUSTRIAL CO., LTD.

City/State/Country

Dongguan Guangdong, CN

Establishment Address

3rd Floor, No. 21, Hongfu North Road, Qingshuiao, Jianshazhou Community, Wanjiang Street, Dongguan Guangdong 523063, CN

Establishment Type(s)

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

Owner / Operator

KANG ZE INDUSTRIAL CO., LTD (Owner Number: 10039351)

Owner / Operator Contact Address

3rd Floor, No. 21, Hongfu North Road, Qingshuiao, Jianshazhou Community, Wanjiang Street, Dongguan, CN-GD 523063, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Disposable Thermometer cover and probe cover; Oral Disposable Thermometer Sheaths Probe Cover Disposable Digital Oral Thermometer Sheaths Digital Thermometer Probe Cover

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FLK	Thermometer, Clinical Mercury	General Hospital	Class 2	880.2920	2011-12-29
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2011-12-29
KIA	Cover, Cast	General Hospital	Class 1	880.6185	2025-08-13

Official Correspondent

Rongkang Mo

US Agent Details

Peter Yang Business: JIAMEI CONSULTING INC. Email: info@jiameiconsulting.com Phone: (310) 2168437

Related Public Records

Same Entity

KANG ZE INDUSTRIAL 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
3006897996	HOSPITAL & HOMECARE IMP. & EXP. CO., LTD	NANJING Jiangsu, CN
3012314549	NINGBO TIANBO FIRST AID PRODUCT CO., LTD.	Ningbo Zhejiang, CN
8043685	CHINA (SHENYANG) MED-LAND IMP/EXP CORP., LTD.	Shanghai, CN
3011137372	Teleflex Medical LLC	Morrisville, NC, US
3031700059	P BHOGILAL PVT LTD	Kolkata West Bengal, IN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009518322. Last updated year: 2026. Please use registration number 3009518322 when referencing this establishment in official correspondence.