Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003903031

FEI Number

3003903031

Entity Name

WELL LEAD MEDICAL CO. LTD

City/State/Country

GUANGZHOU Guangdong, CN

Establishment Address

C-4 JINHU INDUSTRIAL ESTATE, HUALONG, PAN YU, GUANGZHOU Guangdong 511434, CN

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer),Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

WELL LEAD MEDICAL CO. LTD (Owner Number: 9045441)

Owner / Operator Contact Address

No.47 Guomao Avenue South, HUALONG, PAN YU, GUANGZHOU, CN-GD 511434, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

WELL LEAD SILICONE AND LATEX FOLEY CATHETERS Silicone Foley Catheter Well Lead Foley Catheters Latex Foley Catheter Evacuator Silicone Reservoir Red Urethral Catheter Anesthesia Breathing Circuit Kit Oropharyngeal Airway Laryngeal Mask W/Gastirc Access Qsafe Laryngeal Mask Airway Slimway Laryngeal Mask Airway Salvus Laryngeal Mask Airway Laryngeal Mask Device DYNASEAL Dynamic Supraglottic Airway Multi-channel Flexible Laryngeal Airway Mask Male External Catheter (Non-Sterile) Laparoscopic Retrieval Bag Well Lead Extraction Bag Well Lead Hydrophilic Silicone Foley Catheter Well lead Breathing Circuit Disposable Air Cushion Face Mask Stone Collection Bottle Stryker 8001 Series Foley Catheter Temperature Probe MEAS 4400 Series Foley Catheter Temperature Probe Philips Foley Catheter Temperature Probe Silicone Foley Cath w/Temp Sensor Irrigation Catheter Irrigation Tubing Set All Silicone Foley Catheter with Temperature Sensor ARGYLE SILICONE SALEM SUMP TUBE

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EZL	Catheter, Retention Type, Balloon	Gastroenterology, Urology	Class 2	876.5130	2008-11-06
FFD	Evacuator, Bladder, Manually Operated	Gastroenterology, Urology	Class 1	876.4370	2023-08-21
GBM	Catheter, Urethral	Gastroenterology, Urology	Class 2	876.5130	2017-05-27
GCY	Apparatus, Suction, Single Patient Use, Portable, Nonpowered	General, Plastic Surgery	Class 1	878.4680	2026-05-18
EZL	Catheter, Retention Type, Balloon	Gastroenterology, Urology	Class 2	876.5130	2019-04-03
EYB	Catheter, Ureteral, Gastro-Urology	Gastroenterology, Urology	Class 2	876.5130	2016-04-11
OFP	Anesthesia Breathing Circuit Kit (Adult & Pediatric)	Anesthesiology	Class 1	868.5240	2024-01-26
CAE	Airway, Oropharyngeal, Anesthesiology	Anesthesiology	Class 1	868.5110	2004-05-06
NNX	Device, Incontinence, Urosheath Type, Non-Sterile	Gastroenterology, Urology	Class 1	876.5250	2020-09-21
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2017-01-05
EZL	Catheter, Retention Type, Balloon	Gastroenterology, Urology	Class 2	876.5130	2014-12-15
EZL	Catheter, Retention Type, Balloon	Gastroenterology, Urology	Class 2	876.5130	2024-01-10
CAI	Circuit, Breathing (W Connector, Adaptor, Y Piece)	Anesthesiology	Class 1	868.5240	2013-04-24
BSJ	Mask, Gas, Anesthetic	Anesthesiology	Class 1	868.5550	2008-03-03
KOD	Catheter, Urological	Gastroenterology, Urology	Class 2	876.5130	2024-01-10
KDQ	Bottle, Collection, Vacuum	General Hospital	Class 2	880.6740	2018-03-24
EZL	Catheter, Retention Type, Balloon	Gastroenterology, Urology	Class 2	876.5130	2015-11-24
EZL	Catheter, Retention Type, Balloon	Gastroenterology, Urology	Class 2	876.5130	2009-10-22
GBX	Catheter, Irrigation	General, Plastic Surgery	Class 1	878.4200	2015-06-09
EZL	Catheter, Retention Type, Balloon	Gastroenterology, Urology	Class 2	876.5130	2021-04-14
EZL	Catheter, Retention Type, Balloon	Gastroenterology, Urology	Class 2	876.5130	2024-01-16
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2026-04-02

Official Correspondent

Jenny Zhu

US Agent Details

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

Related Public Records

Same Entity

WELL LEAD MEDICAL CO. LTD

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3010400865	WELL LEAD MEDICAL CO. LTD	GUANGZHOU Guangdong, CN

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K233013	Silq Technologies Corporation	2-Way 100% Silicone Cleartract Catheter	2024-01-23
K883982	Iberhospitex, S.A.	DRENOVAC	1989-02-23
K914997	Conmedcorp	ASP-IRRATOR	1992-01-07
K153773	Olympus Medical Systems Corp.	Disposal Lens Cleaning Sheath	2016-11-22
K940141	Micro-Medical Devices, Inc.	LAPARAOSCOPES ELECTRONIC WITH STERILE SHEATH	1994-05-19

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0020-04	Vital Concepts, Inc.	1	Huntington Instruments brand Irrigation Aspiration System with Single Spike Tubing and 33 cm Probe, Disposable (single use only), sterile, latex free. Catalog # 55040. Labeled as Manufactured for Huntington Instruments, Ogden Utah.
Z-0021-04	Vital Concepts, Inc.	1	Irrigation Aspiration System with Double Spike Tubing and 33 cm Probe, Disposable (single use only), sterile, latex free. Catalog # 55060. HYDRO-PRO brand labeled as sold by Vital Concepts, Inc., Grand Rapids, Michigan. Huntington Instruments brand labeled as Manufactured for Huntington Instruments, Ogden Utah. Quanta Technologies L.L.C. brand Manufactured for Quanta Technologies, L.L.C., Tucson, AZ. Catalogue # 55060-10 sold in Canada and labeled as Manufactured for Jac-Cell Medic, Dorval, Quebec.
Z-0022-04	Vital Concepts, Inc.	1	HYDRO-PRO brand Irrigation Aspiration System with double Spike Tubing, no Probe, Disposable (single use only), sterile, latex free. Catalog # 55160. Vital Concepts, Inc., Grand Rapids, Michigan.
Z-0023-04	Vital Concepts, Inc.	1	HYDRO-PRO brand Suction-Irrigation System without Probe, Disposable (single use only), sterile, latex free. R-Med Re-Order # 55170R; Distributed by R-Med, Inc., Orgeon, OH
Z-0024-04	Vital Concepts, Inc.	1	Quanta Technologies L.L.C. brand REORDER # LAPKIT 3. Contents 1 -55060 Suction/Irrigation Valve 2- 30012 Insufflation Tubing set 3- 5010 Anti Fog Solution with Sponge. Manufactured for Quanta Technologies, L.L.C., Tucson, AZ.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003903031. Last updated year: 2026. Please use registration number 3003903031 when referencing this establishment in official correspondence.