Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3020468145

FEI Number

3020468145

Entity Name

SHANGHAI LEJOY CO., LTD

City/State/Country

Shanghai, CN

Establishment Address

757 Guangfu Road, Minmetals Building, Shanghai 200070, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

Shanghai Lejoy Co., LTD (Owner Number: 10088511)

Owner / Operator Contact Address

757 Guangfu Road, Minmetals Building, Shanghai, CN-SH 200070, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

SUPPORT, PATIENT POSITION Light, surgical, accessories NON-SURGICAL ISOLATION GOWN TRAY, SURGICAL, INSTRUMENT CONTAINER, LIQUID MEDICATION, GRADUATED MARKER, SKIN HANDLE, SCALPEL BASIN, EMESIS Electrosurgical, cutting & coagulation & accessories Electrosurgical, cutting & coagulation & accessories Surgical Absorbent Mats Kit, surgical instrument, disposable NEEDLE, SUTURING, DISPOSABLE COMPONENT, TRACTION, NON-INVASIVE SYRINGE, IRRIGATING (NON DENTAL) CATHETER AND TIP, SUCTION

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CCX	Support, Patient Position	Anesthesiology	Class 1	868.6820	2023-11-03
FTA	Light, Surgical, Accessories	General, Plastic Surgery	Class 2	878.4580	2023-11-03
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2023-11-03
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2023-11-03
KYW	Container, Liquid Medication, Graduated	General Hospital	Class 1	880.6430	2023-11-03
FZZ	Marker, Skin	General, Plastic Surgery	Class 1	878.4660	2023-11-03
GDZ	Handle, Scalpel	General, Plastic Surgery	Class 1	878.4800	2023-11-03
FNY	Basin, Emesis	General Hospital	Class 1	880.6730	2023-11-03
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2023-11-03
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2023-11-03
FRL	Fiber, Medical, Absorbent	General Hospital	Class 1	880.5300	2023-08-21
KDD	Kit, Surgical Instrument, Disposable	General, Plastic Surgery	Class 1	878.4800	2023-11-03
GAB	Needle, Suturing, Disposable	General, Plastic Surgery	Class 1	878.4800	2023-11-03
KQZ	Component, Traction, Non-Invasive	Orthopedic	Class 1	888.5890	2023-11-03
KYZ	Syringe, Irrigating (Non Dental)	General Hospital	Class 1	880.6960	2023-11-03
JOL	Catheter And Tip, Suction	General Hospital	Class 2	880.6740	2023-11-03

Official Correspondent

Peter Chen

US Agent Details

Paul Lloyd Business: XODUS MEDICAL INC Email: plloyd@xodusmedical.com Phone: (724) 3375500

Related Public Records

Same Entity

Shanghai Lejoy 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
K970809	Somnus Medical Technologies, Inc.	BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL	1997-06-18
K222793	C.R. Bard, Inc.	WavelinQ Generator	2022-10-17
K002257	Tecno Instruments (Pvt.) , Ltd.	TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100	2000-10-19
K193591	Bowa-Electronics GmbH & Co. KG	ARC 400	2020-04-02
K192128	Sutter Medizintechnik GmbH	Sutter Arrowtip Monopolar Electrodes	2019-10-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2016	Zimmer, Inc.	1	Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.
Z-0039-2018	Teleflex Medical	1	Pilling Knife Handles: a) REF 352950 b) REF 352953 c) REF 352951 d) REF 352957 e) REF 352952 : Reusable surgical knife handles, which are intended for use with blades which are inserted into a slot in the handle.
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-0007-2013	Invuity, Inc.	2	BriteField illuminated Suction Device; Model numbers 8Fr, 10Fr and 12Fr, Kit (included 8Fr, 10Fr and 12Fr and a sterilization tray. The Invuity Brite Field Illuminated Suction Device is intended to aspirate from the surgical site and to provide illumination from a high intensity light source.

Similar Registrations

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3004777218	U.S. SURGITECH, INC.	Carol Stream, IL, US
3007441485	MOSER-BAER AG	Sumiswald Bern, CH
3003495693	EMERALD NONWOVENS INTL. CO., LTD.	Phetchaburi, TH
3012226300	AVILIGN MEDICAL	Sialkot Punjab, PK

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3020468145. Last updated year: 2026. Please use registration number 3020468145 when referencing this establishment in official correspondence.