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Well Lead Medical Co. Ltd: FDA-registered device maker in GUANGZHOU Guangdong, China, 7 510(k) clearances

Name: Well Lead Medical Co. Ltd FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Well Lead Medical Co. Ltd is registered with the FDA (registration 3003903031) in GUANGZHOU Guangdong, China. It lists 22 device types. The FDA files 7 510(k) clearances under its listings, the newest dated January 14, 2022. Registered through 2027. FDA data exported November 3, 2026.

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Get makers like this one Watch Well Lead Medical Co. Ltd

FDA registration number: 3003903031
Address: C-4 Jinhu Industrial Estate Hualong, Pan Yu, GUANGZHOU Guangdong, China, 511434
Owner or operator: WELL LEAD MEDICAL CO. LTD (9045441)
Roles: Contract manufacturer, Contract sterilizer, Exporter to the US, Manufacturer
First device listed: May 6, 2004
Registered through: 2027
Brand names listed: ARGYLE SILICONE SALEM SUMP TUBE, All Silicone Foley Catheter with Temperature Sensor, Anesthesia Breathing Circuit Kit, DEVMED DOUBLE-BALLOON UROLOGICAL CATHETER, DRAIN PENROSE, DYNASEAL Dynamic Supraglottic Airway, Disposable Air Cushion Face Mask, Evacuator and more

Devices it lists

Device	Product code	Class	Role	Source
Airway, Oropharyngeal, Anesthesiology	CAE	1	Manufacturer	accessdata.fda.gov
Anesthesia Breathing Circuit Kit (Adult & Pediatric)	OFP	1	Manufacturer	accessdata.fda.gov
Apparatus, Suction, Single Patient Use, Portable, Nonpowered	GCY	1	Manufacturer	accessdata.fda.gov
Bottle, Collection, Vacuum	KDQ	2	Manufacturer	accessdata.fda.gov
Catheter, Irrigation	GBX	1	Manufacturer	accessdata.fda.gov
Catheter, Peritoneal	GBW	1	Manufacturer	accessdata.fda.gov
Catheter, Retention Type, Balloon	EZL	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Catheter, Straight	EZD	2	Exporter to the US	accessdata.fda.gov
Catheter, Ureteral, Gastro-Urology	EYB	2	Contract manufacturer	accessdata.fda.gov
Catheter, Urological	KOD	2	Contract manufacturer	accessdata.fda.gov
Circuit, Breathing (W Connector, Adaptor, Y Piece)	CAI	1	Manufacturer	accessdata.fda.gov
Continuous Measurement Thermometer	FLL	2	Contract manufacturer	accessdata.fda.gov
Device, Incontinence, Urosheath Type, Non-Sterile	NNX	1	Manufacturer	accessdata.fda.gov
Endoscope Channel Accessory	ODC	2	Manufacturer	accessdata.fda.gov
Evacuator, Bladder, Manually Operated	FFD	1	Manufacturer	accessdata.fda.gov
Gastrointestinal Tubes With Enteral Specific Connectors	PIF	2	Contract manufacturer, Contract sterilizer	accessdata.fda.gov
Laparoscope, General & Plastic Surgery	GCJ	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Lavage, Jet	FQH	2	Manufacturer	accessdata.fda.gov
Mask, Gas, Anesthetic	BSJ	1	Manufacturer	accessdata.fda.gov
Tube, Double Lumen For Intestinal Decompression And/Or Intubation	FEG	2	Contract manufacturer, Contract sterilizer	accessdata.fda.gov
Tube, Tracheal (W/Wo Connector)	BTR	2	Manufacturer	accessdata.fda.gov
Tubes, Gastrointestinal (And Accessories)	KNT	2	Contract manufacturer, Contract sterilizer, Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
January 14, 2022	K211814	Wellead Endoscopic Seal	ODC	Substantially Equivalent	Well Lead Medical Co., Ltd.	accessdata.fda.gov
April 8, 2021	K202134	Well Lead All Silicone Foley Catheter with Temperature Sensor	EZL	Substantially Equivalent	Well Lead Medical Co., Ltd.	accessdata.fda.gov
October 11, 2017	K162340	Stomach Tube	KNT	Substantially Equivalent	Well Lead Medical Co., Ltd.	accessdata.fda.gov
November 29, 2016	K160801	Well Lead Extraction Bag	GCJ	Substantially Equivalent	Well Lead Medical Co., Ltd.	accessdata.fda.gov
February 24, 2014	K133615	WELL LEAD PVC HYDROPHILIC URETHRAL CATHETER	EZD	Substantially Equivalent	Well Lead Medical Co., Ltd.	accessdata.fda.gov
October 8, 2008	K082815	WELL LEAD SILICONE AND LATEX FOLEY CATHETERS	EZL	Substantially Equivalent	Well Lead Medical Instruments	accessdata.fda.gov
July 10, 2008	K073383	WELL LEAD REINFORCED ENDOTRACHEAL TUBE	BTR	Substantially Equivalent	Well Lead Medical Instruments	accessdata.fda.gov

Compare with other makers

Updated January 14, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.