Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006750986

FEI Number

3006750986

Entity Name

Zhangjiagang Xiehe Medical Apparatus & Instruments Co., Ltd.

City/State/Country

ZHANGJIAGANG Jiangsu, CN

Establishment Address

No.7th Middle Xinzha Road, Zhashang Industrial Zone,Yangshe Town, ZHANGJIAGANG Jiangsu 215600, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Zhangjiagang Xiehe Medical Apparatus & Instruments Co., Ltd. (Owner Number: 9105619)

Owner / Operator Contact Address

No.7th Middle Xinzha Road, Zhashang Industrial Zone, Yangshe Town, ZHANGJIAGANG, CN-JS 215600, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Face Mask SPADE STRETCHER AMBULANCE STRETCHER ORTHOSIS, CERVICAL Stretcher, patient restraint Wheeled Stretcher Protective Mask KN95 Tourniquet HEAD IMMOBILIZER traction splint Scissors

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	2023-03-08
FPP	Stretcher, Hand-Carried	General Hospital	Class 1	880.6900	2007-08-09
IQK	Orthosis, Cervical	Physical Medicine	Class 1	890.3490	2012-06-21
NZD	Stretcher, Patient Restraint	General Hospital	Class 1	880.6900	2012-06-22
FPO	Stretcher, Wheeled	General Hospital	Class 2	880.6910	2010-08-31
MSH	Respirator, Surgical	General, Plastic Surgery	Class 2	878.4040	2023-03-08
GAX	Tourniquet, Nonpneumatic	General, Plastic Surgery	Class 1	878.5900	2020-07-06
MRI	Orthosis, Truncal/Orthosis, Limb	Physical Medicine	Class 1	890.3490	2009-10-21
HSP	Splint, Traction	Orthopedic	Class 1	888.5890	2013-06-04
LRW	Scissors, General, Surgical	General, Plastic Surgery	Class 1	878.4800	2020-07-06

Official Correspondent

WEIMING CHU

US Agent Details

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

Related Public Records

Same Entity

Zhangjiagang Xiehe Medical Apparatus & Instruments 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

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0006-2025	Ossur H F Grjothals 5 Reykjavik Iceland	1	Miami J Select Collar, Catalog: MJS-101; Miami J Select Collar Set, Catalog: MJSR-101
Z-0023-05	Stryker Medical	2	Stryker brand Rugged EZ-Pro R4 Ambulance Cot, model 6092.

Similar Registrations

Registration Number	Establishment Name	Location
9680454	EMPRESAS IAI S DE RL DE C.V.	H. MATAMOROS Tamaulipas, MX
3010227982	Tianjin Zhengtian Medical Instrument Co., Ltd.	Tianjin, CN
3016871880	PRIMEX DESIGN & FABRICATION	Richmond, IN, US
3005360866	QEL DOMINICANA S.A.	ESPERANZA Valverde, DO
3010601984	Jiangsu Haize Medical Scientific Development Co.,Ltd.	Wuxi Jiangsu, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006750986. Last updated year: 2026. Please use registration number 3006750986 when referencing this establishment in official correspondence.