Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9680410

FEI Number

3002808150

Entity Name

SUZHOU HUANQIU ACUPUNCTURE MEDICAL APPLIANCE CO., LTD

City/State/Country

XIANGCHENG DISTRICT SUZHOU CITY Jiangsu, CN

Establishment Address

NO. 8, CHUANGXIN INDUSTRIAL ZONE, WEITANG TOWN, XIANGCHENG DISTRICT SUZHOU CITY Jiangsu 215134, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

SUZHOU HUANQIU ACUPUNCTURE MEDICAL APPLIANCE CO., LTD (Owner Number: 9008809)

Owner / Operator Contact Address

NO. 8, CHUANGXIN INDUSTRIAL ZONE, WEITANG TOWN, XIANGCHENG DISTRICT SUZHOU CITY, CN-JS 215134, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K011242

PMA Number

N/A

All Registered Proprietary Names

HUAN QIU AND SUPER (TWO BRAND YI SHEN BIAN QUE Super HUAN QIU

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MQX	Needle, Acupuncture, Single Use	General Hospital	Class 2	880.5580	2000-01-28

Official Correspondent

CHUANJIAN TU

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

SUZHOU HUANQIU ACUPUNCTURE MEDICAL APPLIANCE CO., LTD

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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9680410. Last updated year: 2026. Please use registration number 9680410 when referencing this establishment in official correspondence.