Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016838609

FEI Number

3016838609

Entity Name

SHENZHEN TAIKANG MEDICAL EQUIPMENT CO.,LTD.

City/State/Country

Shenzhen Guangdong, CN

Establishment Address

3F East, Building 4, Lanzhu East Road 8,Grand Industrial Park, Pingshan District, Shenzhen Guangdong 518015, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Shenzhen Taikang Medical Equipment Co.,Ltd. (Owner Number: 10084032)

Owner / Operator Contact Address

3F East, Building 4, Lanzhu East Road 8,Grand Industrial Park, Pingshan District, Shenzhen, CN-GD 518015, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K211940

PMA Number

N/A

All Registered Proprietary Names

Fetal Doppler Modle TK-T802CRBT.TK-T803CRBT.TK-T805CRBT.TK-T806CRBT.TK-T808CRBT Fetal Doppler Modle TK-T808,TK-T808R,TK-T808RBT,TK-T803,TK-T803R,TK-T803C,TK-T803CR,TK-T803RBT,TK-T803CBT, Fetal Doppler Modle TKT802CR.TK-T802R.TK-T802C.TKT802.TK-T806CR.TK-T806R.TK-T806C.TK-T806: Fetal Doppler Modle TKT805CR. Fetal Doppler Modle TK-T802BT.TK-T803BT.TK-T805BT.TK-T806BT.TK-T808BT

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KNG	Monitor, Ultrasonic, Fetal	Obstetrics/Gynecology	Class 2	884.2660	2022-01-11

Official Correspondent

Shigui Du

US Agent Details

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

Related Public Records

Same Entity

Shenzhen Taikang Medical Equipment Co.,Ltd.

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

View Entity Profile →

Similar Registrations

Registration Number	Establishment Name	Location
1061927	INTERNATIONAL STERILIZATION LABORATORY, LLC	GROVELAND, FL, US
3012725363	EASY HEALTHCARE CORPORATION	Darien, IL, US
3008756262	SHENZHEN BESTMAN INSTRUMENT CO.,LTD	Shenzhen Guangdong, CN
3030151584	IMEX, LLC	Fulton, MD, US
3008457078	Shenzhen Biocare Bio-Medical Equipment Co., Ltd.	Shenzhen Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016838609. Last updated year: 2026. Please use registration number 3016838609 when referencing this establishment in official correspondence.