Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3042255021

FEI Number

3042255021

Entity Name

DONGGUAN SENMED MEDICAL INSTRUMENT CO., LTD.

City/State/Country

Dongguar City Guangdong, CN

Establishment Address

Room 201&301, Building 1, No. 48-1, Chang'an Xinhong Road, Chang'an Town,, Dongguar City Guangdong 523850, 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

Dongguan Senmed Medical Instrument Co., Ltd. (Owner Number: 10094170)

Owner / Operator Contact Address

Room 201&301, Building 1, No. 48-1, Chang'an Xinhong Road, Chang'an Town,, Dongguar City, CN-GD 523850, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Retractor LaproClear Suture Passer LaproClose

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2025-11-17
MNL	Accessories, Cleaning Brushes, For Endoscope	Gastroenterology, Urology	Class 1	876.1500	2025-11-18
HWQ	Passer	Orthopedic	Class 1	888.4540	2025-11-17

Official Correspondent

Joshua. tseng

US Agent Details

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

Related Public Records

Same Entity

Dongguan Senmed Medical Instrument 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.

Similar Registrations

Registration Number	Establishment Name	Location
3011050528	FREEHOLD SURGICAL, INC.	New Hope, PA, US
3021006167	KIMS MED CO., LTD.	Gwangju, KR
3045009502	WISDOM MEDICAL TECHNOLOGY (SHANGHAI) CO., LTD	Shanghai, CN
3032847175	BIOPHYX SURGICAL, INC.	Edgewater, MD, US
9681129	BEMA-GMBH & CO. KG	EMMINGEN Baden-Wurttemberg, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3042255021. Last updated year: 2026. Please use registration number 3042255021 when referencing this establishment in official correspondence.