Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9615551

FEI Number

3003254346

Entity Name

SHUNDE LUCAS INDUSTRIES

City/State/Country

Foshan City Guangdong, CN

Establishment Address

No.207-1, Liangxing Road, Honggang Community, Daliang Sub-District, Shunde District, Foshan City Guangdong 528300, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

The Lucas Group (Owner Number: 9035557)

Owner / Operator Contact Address

6027 Stitt St., Monroe, NC 28110, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

SHUNDE LUCAS examination gown surgical apparel Disposable Surgical Apparel SHUNDE LUCAS Disposable Bedding SHUNDE LUCAS surgical Drape SHUNDE LUCAS SURGICAL Dress SHUNDE LUCAS SURGICAL SUIT surgical apparel Disposable Surgical Apparel SHUNDE LUCAS HAND-CARRIED STRETCHER surgical apparel Disposable Surgical Apparel

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FME	Gown, Examination	General Hospital	Class 1	880.6265	1998-11-10
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2003-05-29
GAX	Tourniquet, Nonpneumatic	General, Plastic Surgery	Class 1	878.5900	2003-05-29
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2003-04-25
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2014-09-25
FYE	Dress, Surgical	General, Plastic Surgery	Class 1	878.4040	2010-11-03
FXO	Suit, Surgical	General, Plastic Surgery	Class 1	878.4040	2011-10-10
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2003-05-29
FPP	Stretcher, Hand-Carried	General Hospital	Class 1	880.6900	2011-09-13
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2003-05-29

Official Correspondent

Paul Lucas

US Agent Details

Paul Lucas Business: The Lucas Group Email: plucas@thelucasgroup.net Phone: (704) 6093574

Related Public Records

Same Entity

The Lucas Group

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
K914369	Deroyal Industries, Inc.	QUALTEX MAGNETIC INSTRUMENT DRAPE	1991-12-02
K812809	Abco Dealers, Inc.	STERILE ADHERENT DRAPES	1981-11-06
K910084	Biocor Medical, Inc.	SURGICAL DRAPE	1991-03-19

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9615551. Last updated year: 2026. Please use registration number 9615551 when referencing this establishment in official correspondence.