Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010683392

FEI Number

3010683392

Entity Name

JIANGSU KEHUA MEDICAL INSTRUMENT TECHNOLOGY CO., LTD.

City/State/Country

Dongtai Jiangsu, CN

Establishment Address

West Industrial Park ,Wulie Town, Dongtai Jiangsu 224200, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

JIANGSU KEHUA MEDICAL INSTRUMENT TECHNOLOGY CO., LTD. (Owner Number: 10050521)

Owner / Operator Contact Address

West Industrial Park ,Wulie Town, Dongtai, CN-JS 224200, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

capillary blood collector; capillary pipette; capillary tubes; micropipette; sample transfer pipets; transfer pipette Extraction test tubes, plastic droppers, buffer vial, saliva collection SD Ezi Tube+ plastic pipette, POCT ampule, pre-filled tube plastic inverted cup , buffer solution

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JRC	Micro Pipette	Clinical Chemistry	Class 1	862.2050	2015-11-28

Official Correspondent

Fang Chen

US Agent Details

James H. Liao Email: james@sino2us.com Phone: (310) 3758169

Related Public Records

Same Entity

JIANGSU KEHUA MEDICAL INSTRUMENT TECHNOLOGY CO., LTD.

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010683392. Last updated year: 2026. Please use registration number 3010683392 when referencing this establishment in official correspondence.