Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014931612

FEI Number

3014931612

Entity Name

DONGGUAN TONDAUS MEDITECH CO.,LTD.

City/State/Country

Dongguan Guangdong, CN

Establishment Address

3rd Floor, No.27, Rd.Guantai, Chiling Community, Houjie Town, Dongguan Guangdong 523900, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Dongguan Tondaus Meditech Co.,ltd. (Owner Number: 10058320)

Owner / Operator Contact Address

3rd Floor, No.27, Rd.Guantai, Chiling Community, Houjie Town, Dongguan, CN-GD 523900, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

IN2HC Tip Cleaners T3023 TR04-1 TF03 TR03 TS01 TR03-1 TR04 TS02 TD01 TS02-1 TF02-1 TF01-1 TR01-1 TS03 TS04 T3023-1 TS05-1 TD01-1 TS05 TS01-1 TF01 TS03-1 TF02 TR02 TR01

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2020-08-15
FZZ	Marker, Skin	General, Plastic Surgery	Class 1	878.4660	2018-08-22

Official Correspondent

No official correspondent registered.

US Agent Details

Zhengxing Ke Email: xidileo@hotmail.com Phone: (718) 6662872

Related Public Records

Same Entity

Dongguan Tondaus Meditech 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
K970809	Somnus Medical Technologies, Inc.	BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL	1997-06-18
K222793	C.R. Bard, Inc.	WavelinQ Generator	2022-10-17
K002257	Tecno Instruments (Pvt.) , Ltd.	TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100	2000-10-19
K193591	Bowa-Electronics GmbH & Co. KG	ARC 400	2020-04-02
K192128	Sutter Medizintechnik GmbH	Sutter Arrowtip Monopolar Electrodes	2019-10-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0031-06	Rita Medical Systems	2	Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826

Similar Registrations

Registration Number	Establishment Name	Location
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3020623326	TRIWORKS GROUP S.R.L.	Palata Campobasso, IT
3012616488	BRERA MEDICAL INCORPORATED	Northborough, MA, US
3012940012	Sutter Medical Technologies USA Inc.	Alpharetta, GA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014931612. Last updated year: 2026. Please use registration number 3014931612 when referencing this establishment in official correspondence.