Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010400865

FEI Number

3010400865

Entity Name

WELL LEAD MEDICAL CO. LTD

City/State/Country

GUANGZHOU Guangdong, CN

Establishment Address

No. 47 Guomao Avenue South, Panyu, GUANGZHOU Guangdong 511434, CN

Establishment Type(s)

Manufacture Medical Device

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

Needle Guide TRACHEAL TUBE Male External Catheter (Non-Sterile) Urodynamic Catheter PVC Urethral Catheter Well Lead Reinforced ET Tube Reinforced Endotracheal Tube Drainage Bags Deluxe Drainage Bags Leg Bag Endotracheal Tube Endotracheal Tube with Evacuation Lumen ClearPetra Suction-Evacuation Sheath Urethral dilator Silicone Foley Cath w/Temp Sensor Cricothyrotomy kit Nasal Cannula Non-Rebreath Mask PVC Hydrophilic Urethral Catheter Red Urethral Catheter DRAIN PENROSE Suction Catheter Irrigation Catheter Irrigation Tubing Set ARGYLE SILICONE SALEM SUMP TUBE Wellead Nephrostomy Introduction Needle Nephrostomy Introduction Needle Salem Sump Silicone Dual Lumen Stomach Tube with ENFit Connection Stomach Tube Intubating Stylet 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 Wellead Endoscopic Seal Portable Roller Irrigation Pump WELL LEAD SILICONE AND LATEX FOLEY CATHETERS Silicone Foley Catheter Well Lead Foley Catheters Latex Foley Catheter Trach- Vac Endotracheal Tube (SFTVVC) Subglottic Suction Tube With Salter Flex-Tip And Salter ThinCuff Trach- Vac Endotracheal Tube (SFTVPU) Subglottic Suction Tube With Salter Flex-Tip And Salter ThinCuff PARKER FLEX-TIP TRACHEAL TUBE Disposable Air Cushion Face Mask ClearPetra Suction-Evacuation Sheath Well lead Breathing Circuit OXYGEN MASK Tracheostomy Mask Aerosol Mask Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic Intermittent Catheter Compact Urological Guide Wire PVC Urethral Catheter Endotracheal Tube with Evacuation Lumen Stone Collection Bottle OXYGEN TUBING WELL LEAD OXYGEN TUBING Tracheostomy Tube Laparoscopic Retrieval Bag Well Lead Extraction Bag

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OIJ	Biopsy Needle Guide Kit	Radiology	Class 2	892.1560	2026-03-30
BTR	Tube, Tracheal (W/Wo Connector)	Anesthesiology	Class 2	868.5730	2007-10-12
EZL	Catheter, Retention Type, Balloon	Gastroenterology, Urology	Class 2	876.5130	2024-01-10
KOD	Catheter, Urological	Gastroenterology, Urology	Class 2	876.5130	2024-01-10
NNX	Device, Incontinence, Urosheath Type, Non-Sterile	Gastroenterology, Urology	Class 1	876.5250	2020-09-21
FEN	Device, Cystometric, Hydraulic	Gastroenterology, Urology	Class 2	876.1620	2021-03-02
EZD	Catheter, Straight	Gastroenterology, Urology	Class 2	876.5130	2011-03-21
BTR	Tube, Tracheal (W/Wo Connector)	Anesthesiology	Class 2	868.5730	2008-07-16
KNX	Collector, Urine, (And Accessories) For Indwelling Catheter	Gastroenterology, Urology	Class 2	876.5250	2011-03-11
BTR	Tube, Tracheal (W/Wo Connector)	Anesthesiology	Class 2	868.5730	2024-05-28
BTR	Tube, Tracheal (W/Wo Connector)	Anesthesiology	Class 2	868.5730	2020-03-25
FGA	Kit, Nephroscope	Gastroenterology, Urology	Class 2	876.1500	2017-01-05
FAJ	Cystoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2017-01-05
FED	Endoscopic Access Overtube, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2017-01-05
KOE	Dilator, Urethral	Gastroenterology, Urology	Class 2	876.5520	2020-05-08
EZL	Catheter, Retention Type, Balloon	Gastroenterology, Urology	Class 2	876.5130	2009-10-22
OGP	Cricothyrotomy Kit	Anesthesiology	Class 2	868.5800	2021-09-23
CAT	Cannula, Nasal, Oxygen	Anesthesiology	Class 1	868.5340	2005-03-04
KGB	Mask, Oxygen, Non-Rebreathing	Anesthesiology	Class 1	868.5570	2005-03-04
EZD	Catheter, Straight	Gastroenterology, Urology	Class 2	876.5130	2023-06-05
EYB	Catheter, Ureteral, Gastro-Urology	Gastroenterology, Urology	Class 2	876.5130	2016-04-11
GBW	Catheter, Peritoneal	General, Plastic Surgery	Class 1	878.4200	2011-04-14
BSY	Catheters, Suction, Tracheobronchial	Anesthesiology	Class 1	868.6810	2014-05-06
GBX	Catheter, Irrigation	General, Plastic Surgery	Class 1	878.4200	2015-06-09
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2026-04-02
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2023-05-31
FEG	Tube, Double Lumen For Intestinal Decompression And/Or Intubation	Gastroenterology, Urology	Class 2	876.5980	2026-04-02
PIF	Gastrointestinal Tubes With Enteral Specific Connectors	Gastroenterology, Urology	Class 2	876.5980	2026-04-02
EZL	Catheter, Retention Type, Balloon	Gastroenterology, Urology	Class 2	876.5130	2024-01-10
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2017-11-21
BSR	Stylet, Tracheal Tube	Anesthesiology	Class 1	868.5790	2006-04-24
CAE	Airway, Oropharyngeal, Anesthesiology	Anesthesiology	Class 1	868.5110	2004-05-06
ODC	Endoscope Channel Accessory	Gastroenterology, Urology	Class 2	876.1500	2022-01-16
FQH	Lavage, Jet	General Hospital	Class 2	880.5475	2023-08-15
EZL	Catheter, Retention Type, Balloon	Gastroenterology, Urology	Class 2	876.5130	2008-11-06
GAZ	Tubing, Noninvasive	General Hospital	Class 2	880.6740	2013-12-16
BTR	Tube, Tracheal (W/Wo Connector)	Anesthesiology	Class 2	868.5730	2020-06-05
BTR	Tube, Tracheal (W/Wo Connector)	Anesthesiology	Class 2	868.5730	2020-06-05
BSJ	Mask, Gas, Anesthetic	Anesthesiology	Class 1	868.5550	2008-03-03
FGA	Kit, Nephroscope	Gastroenterology, Urology	Class 2	876.1500	2020-12-17
FED	Endoscopic Access Overtube, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2020-12-17
FAJ	Cystoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2020-12-17
BTR	Tube, Tracheal (W/Wo Connector)	Anesthesiology	Class 2	868.5730	2022-07-26
CAI	Circuit, Breathing (W Connector, Adaptor, Y Piece)	Anesthesiology	Class 1	868.5240	2013-04-24
BYG	Mask, Oxygen	Anesthesiology	Class 1	868.5580	2005-03-04
GBM	Catheter, Urethral	Gastroenterology, Urology	Class 2	876.5130	2025-04-07
OCY	Endoscopic Guidewire, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2022-12-20
EZD	Catheter, Straight	Gastroenterology, Urology	Class 2	876.5130	2014-12-11
BSY	Catheters, Suction, Tracheobronchial	Anesthesiology	Class 1	868.6810	2011-08-31
BTR	Tube, Tracheal (W/Wo Connector)	Anesthesiology	Class 2	868.5730	2011-08-31
KDQ	Bottle, Collection, Vacuum	General Hospital	Class 2	880.6740	2018-03-24
BZO	Set, Tubing And Support, Ventilator (W Harness)	Anesthesiology	Class 1	868.5975	2005-03-04
BTO	Tube, Tracheostomy (W/Wo Connector)	Anesthesiology	Class 2	868.5800	2007-10-12
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2017-01-05
JOL	Catheter And Tip, Suction	General Hospital	Class 2	880.6740	2003-09-10

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
3003903031	WELL LEAD MEDICAL CO. LTD	GUANGZHOU Guangdong, CN

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K233341	Covidien, LLC	Shiley Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP (87430, 87435, 87440, 87445, 87450, 87455, 87460, 87465, 87470, 87475, 87480, 87485, 87490, 87495, 87410)	2024-05-20
K243785	Covidien, LLC	Shiley Oral/Nasal Tracheal Tube with TaperGuard Cuff Reinforced, Murphy Eye Shiley Tracheal Tube TaperGuard Cuff Reinforced with Stylet Shiley Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced Shiley Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced, Murphy Eye Shiley Oral/Nasal Tracheal Tube Cuffless Reinforced	2025-09-25
K233013	Silq Technologies Corporation	2-Way 100% Silicone Cleartract Catheter	2024-01-23
K033719	C.R. Bard, Inc.	BARD TIGERTAIL URETERAL CATHETER	2004-02-04
K820239	American Endoscopy, Inc.	RETRIEVAL FORCEPS	1982-03-26

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0010-2013	C.R. Bard, Inc., Urological Division	2	8 Fr. Bardex Pediatric All-Silicone Foley Catheter with a 3cc balloon. The product is packaged individually with 12 units per corrugated case. The product is sold sterile for single use and is used to provide continuous urinary drainage from the bladder.
Z-0004-2013	Cure Medical LLC	2	Male, 16Fr, Straight-tip Intermittent Urinary Catheters M16. The product is distributed individually or in intermediate boxes containing 30 individual, sterile packaged catheters (PA/PE film and dialyzing paper pouches). There are 30 catheters packaged in sterile pouches that are placed into an intermediate box, 10 of these intermediate boxes packaged into one case. K072539 The Cure Catheter" device, M16, is an intermittent urinary catheter intended to be used by males for the purpose of bladder drainage. It is manufactured with conventional medical grade, latex-free, biocompatible materials. The straight-tip has been designed to eliminate trauma to the urethra and is provided in 16Fr size in an easy-to-open, sterile, single-use package. The coud-tip catheter, M16C, is designed with a curved tip that makes it easier to pass through the curvature of the prostatic urethra in men. It is also used to pass through urethral strictures. This product is prescribed for people who have difficulty or are unable to pass a straight catheter through their urethra and into their bladder.
Z-0012-2023	Hobbs Medical, Inc.	2	Hobbs Medical Flex-Ez Guide Wire Disposable For endoscopy procedures Ref: 3412
Z-0002-2014	King Systems Corp.	1	King LTS-D Oropharyngeal Airways Product Usage: The King LTS-D is intended for use in adult patients (in excess of 25 kg) for controlled ventilation during anesthesia for procedures that are short in duration and when the patient is considered to have a low risk of aspiration of stomach contents.
Z-0033-04	VIASYS Med Systems	1	Neonatal/Infant Hyperinflation Circuit, consisting of a 0.5 L breathing bag, pressure monitoring tube with Bird adapter, oxygen supply tubing, sideport connector with adjustable bleed valve, and 40 cm H2O Popoff elbow; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83124-2

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010400865. Last updated year: 2026. Please use registration number 3010400865 when referencing this establishment in official correspondence.