Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004215929

FEI Number

3004215929

Entity Name

COTRONIC TECHNOLOGY LIMITED

City/State/Country

SHENZHEN, GUANG DONG PROVINCE Guangdong, CN

Establishment Address

Floor 4-6, Block 7, West of ZhouShi Road, XiXiang Street, BaoAn Zone, SHENZHEN, GUANG DONG PROVINCE Guangdong 518126, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

COTRONIC TECHNOLOGY LIMITED (Owner Number: 9057884)

Owner / Operator Contact Address

FLOOR 4, BLOCK 4, FU YUAN IND, ZONE,JIU WEI,XING XIANG, BAO AN, SHEN ZHEN, CN-GD 518126, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K103407

PMA Number

N/A

All Registered Proprietary Names

Nasal Aspirator ASPI, ASPI 2, ASPI 3, ASPI 4, ASPI 5, ASPI-V Nasal Irrigation NI01, NI02, NI03, NI04, NI05, NI06, NI07, NI08, NI09, NI10 Digital soother thermometer model TM03 CR01, CR02, CR03, CR04, CR05, CR06, CR07, CR08, CR09, CR10 Gas Evacuation Tube DIGITAL ELECTRONIC THERMOM TM01, TM02/ TM08, TM09S, TM12FE, TM12F, MT804, TM13 Clinical Electronic Thermometer Model TM22 Clinical Electronic Thermometer Model TM12 & TM21

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KYZ	Syringe, Irrigating (Non Dental)	General Hospital	Class 1	880.6960	2018-05-11
KMA	Irrigator, Powered Nasal	Ear, Nose, Throat	Class 1	874.5550	2023-05-11
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2013-12-01
FFP	Dilator, Rectal	Gastroenterology, Urology	Class 1	876.5450	2023-05-11
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2003-11-14
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2011-05-24

Official Correspondent

No official correspondent registered.

US Agent Details

Charles Mack Business: IRC USA Email: ircfda@gmail.com Phone: (931) 6254938

Related Public Records

Same Entity

COTRONIC TECHNOLOGY 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
3012070313	Nupur Technologies	Buffalo, NY, US
3027473313	ZHEJIANG HOPE PHARMA LTD	Wenzhou Zhejiang, CN
3044994756	SUNMED AP, LTD., WAREHOUSE NO. 2	ZHUHAI Guangdong, CN
2084346	MARINA MEDICAL INSTRUMENTS, INC.	Davie, FL, US
1416980	BAXTER HEALTHCARE CORPORATION	ROUND LAKE, IL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004215929. Last updated year: 2026. Please use registration number 3004215929 when referencing this establishment in official correspondence.