Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3023808185

FEI Number

3023808185

Entity Name

SURGAID MEDICAL (XIAMEN)CO.,LTD.

City/State/Country

Xiamen Fujian, CN

Establishment Address

Building 5 No. 18 Shanbianhong East Road, Haicang District, Xiamen Fujian 361026, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Surgaid Medical (Xiamen)Co.,Ltd. (Owner Number: 10085528)

Owner / Operator Contact Address

Building 5 No. 18 Shanbianhong East Road, Haicang District, Xiamen, CN-FJ 361026, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Single Use Sterile Hook

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GDG	Hook, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2025-05-27
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2022-06-29

Official Correspondent

Bingxin Chen

US Agent Details

Weian Huang Business: JOYSUN USA LLC Email: weian@isosh.com Phone: (949) 4624543

Related Public Records

Same Entity

Surgaid Medical (Xiamen)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
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

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.

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1421879	PHOENIX INSTRUMENTS, INC.	Lisle, IL, US
9681161	REBSTOCK INSTRUMENTS GMBH	DUERBHEIM Baden-Wurttemberg, DE
3003431869	HILBRO INTERNATIONAL (PVT) LIMITED	SIALKOT Punjab, PK

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3023808185. Last updated year: 2026. Please use registration number 3023808185 when referencing this establishment in official correspondence.