Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012416077

FEI Number

3012416077

Entity Name

Smart Technology Co., Ltd.

City/State/Country

Foshan Guangdong, CN

Establishment Address

No. 422 Hai Tian Avenue, Gaoming District, Foshan Guangdong 528500, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

SMART TECHNOLOGY CO LTD (Owner Number: 10051751)

Owner / Operator Contact Address

No. 422 Hai Tian Avenue, Gaoming District, Foshan, CN-GD -, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K203731

PMA Number

N/A

All Registered Proprietary Names

KCP/SYRINGE, ENT Probe Cover KYZ/ SYRINGE, IRRIGATING (NON DENTAL) KYX/ DISPENSER, LIQUID MEDICATION Digital Thermometer (DT100, TH093, TH111, TH074, TH112, TH114)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KCP	Syringe, Ent	Ear, Nose, Throat	Class 1	874.5220	2020-03-09
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2025-12-09
KYZ	Syringe, Irrigating (Non Dental)	General Hospital	Class 1	880.6960	2019-03-03
KYX	Dispenser, Liquid Medication	General Hospital	Class 1	880.6430	2019-02-26
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2021-09-26

Official Correspondent

Mag M Mei

US Agent Details

Mag Mei Business: SMARTEK INC Email: smartek@smtechnology.cn Phone: (812) 5528486

Related Public Records

Same Entity

SMART 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

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1720747	SONTEC INSTRUMENTS, INC.	CENTENNIAL, CO, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012416077. Last updated year: 2026. Please use registration number 3012416077 when referencing this establishment in official correspondence.