Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3024064703

FEI Number

3024064703

Entity Name

SHANGHAI TKLEAN MEDTECH CO., LTD.

City/State/Country

Shanghai, CN

Establishment Address

Room 368, Sector 302, No. 211 North Fute Road, Shanghai Pilot Free Trade Zone, Shanghai 200131, CN

Establishment Type(s)

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

Owner / Operator

Shanghai Tklean Medtech CO., LTD. (Owner Number: 10089286)

Owner / Operator Contact Address

Room 368, Sector 302, No. 211 North Fute Road, Shanghai Pilot Free Trade Zone, Shanghai, CN-SH 200131, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FLG	Cleaner, Ultrasonic, Medical Instrument	General Hospital	Class 1	880.6150	2023-11-25

Official Correspondent

Tianren XU

US Agent Details

Scott Haralson Business: BrandMax INC Email: scott@brandmax.us Phone: (404) 5832577

Related Public Records

Same Entity

Shanghai Tklean Medtech CO., LTD.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0008-2025	Young Dental Manufacturing I, LLC	1	BIOTROL PURIT Clean-It General Purpose Ultrasonic Cleaner, REF PC016, net contents 16 fl. oz., makes 16 gallons of solution.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3024064703. Last updated year: 2026. Please use registration number 3024064703 when referencing this establishment in official correspondence.