Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010601984

FEI Number

3010601984

Entity Name

Jiangsu Haize Medical Scientific Development Co.,Ltd.

City/State/Country

Wuxi Jiangsu, CN

Establishment Address

No.99, Furongzhongsan Road, Xishan Economical Development Zone, Wuxi Jiangsu 214192, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Jiangsu Haize Medical Scientific Development Co.,Ltd. (Owner Number: 10045402)

Owner / Operator Contact Address

No.99, Furongzhongsan Road, Xishan Economical Development Zone, Wuxi, CN-JS 214192, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K161421

PMA Number

N/A

All Registered Proprietary Names

ACCESSORY, SURGICAL APPAREL ViClean Respirator, surgical RETRACTOR Victan CONTAINER, LIQUID MEDICATION, GRADUATED Single Use Surgical Suction Irrigator

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2020-03-25
KGW	Ring (Wound Protector), Drape Retention, Internal	General, Plastic Surgery	Class 2	878.4370	2017-05-24
MSH	Respirator, Surgical	General, Plastic Surgery	Class 2	878.4040	2020-04-13
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2013-11-12
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2023-06-01
KYW	Container, Liquid Medication, Graduated	General Hospital	Class 1	880.6430	2018-12-04
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2017-05-24

Official Correspondent

Jianmin Qian

US Agent Details

Xiaobo Zhang Xiaobo Zhang Email: zhangxb16@haizemed.net Phone: (703) 3092993

Related Public Records

Same Entity

Jiangsu Haize Medical Scientific Development 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
K102092	Prestige Ameritech	PRO GEAR N95 PARTICULATE FILTER RESPIRATOR & SURGICAL MASK, REGULAR SIZE MODEL RP CERIES	2010-10-06
K922626	Andronic Devices, Ltd.	ADEPT INSTRUMENT POSITIONING ACCESSORY	1992-10-19
K820290	The Anspach Effort, Inc.	SELF RETAINING RETRACTOR FOR HAND SURG	1982-03-05
K760422	Cutter Laboratories, Inc.	SURGICAL RETRACTOR	1976-08-23
K970809	Somnus Medical Technologies, Inc.	BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL	1997-06-18

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0031-2014	Aesculap, Inc.	1	UNITRAC Pneumatic Retraction Arm. A support arm used to hold surgical instruments during surgical procedures.
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
Z-0027-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Banding Kit, REF: K0398 Contains: (2) C0Q04, 5x100mm Threaded Kii Access System (1) C0604, 15x100mm Non-Threaded Separator System w/Universal Seal, for laparoscopic procedures.
Z-0028-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Banding Kit, REF: K0406 Contains: (1) C0658, 11x100mm Threaded Shielded Trocar w/Universal Seal (1) C0522, 5x100mm Threaded Premium Flat Blade (1) C2202, 150mm Insufflation needle (1) C0605, 15x100mm Threaded Separator Access System (1) CB030, 5mm x 35cm Direct Drive Disposable Scissors (2) C4120, 5mm x 38cm Direct Drive Grasper Reposable Cartridge, for laparoscopic procedures.
Z-0029-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Roux-EN-Y Kit, REF: K2129 Contains: (1) C0Q04, 5x100mm Threaded Kii Access System (1) C0130, 12x100mm Optical Separator System, Non-handled (2) C0Q10, 5x100mm Threaded Kii Cannula and Seal (1) C0605, 15mmx100mm Threaded Cannula System, for laparoscopic procedures.

Similar Registrations

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3005360866	QEL DOMINICANA S.A.	ESPERANZA Valverde, DO
3013351831	ANHUI NEWTOSHI CLEANING PRODUCTS CO., LTD.	Tianchang Anhui, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010601984. Last updated year: 2026. Please use registration number 3010601984 when referencing this establishment in official correspondence.