BEUDAMED
    FDA Registration Active 🇨🇳 China

    WELL LEAD MEDICAL CO. LTD

    Reg #: 3010400865 · FEI: 3010400865 · Expires 2026
    View on FDA
    Products
    43
    Proprietary Names
    69
    Establishment Types
    3
    Classifications
    43

    Registration Details

    Registration Name
    WELL LEAD MEDICAL CO. LTD
    Registration Number
    3010400865
    FEI Number
    3010400865
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    No. 47 Guomao Avenue South, Panyu
    City
    GUANGZHOU Guangdong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K042683

    Owner / Operator

    Firm Name
    WELL LEAD MEDICAL CO. LTD
    Operator Number
    9045441
    Address
    No.47 Guomao Avenue South, HUALONG, PAN YU
    City
    GUANGZHOU
    State
    Guangdong
    Postal Code
    511434
    Country
    CN
    Correspondent
    Jenny Zhu

    US Agent

    Business Name
    Regrek LLC
    Contact Name
    Leeyeo Kee
    Address
    19 Holly Cove Ln.
    City
    Dover
    State
    DE
    ZIP
    19901
    Country
    US
    Email
    [email protected]
    Phone
    302 6089028

    Products

    Device Name Product Code
    Biopsy Needle Guide Kit OIJ
    Tube, Tracheal (W/Wo Connector) BTR
    Catheter, Retention Type, Balloon EZL
    Catheter, Urological KOD
    Device, Incontinence, Urosheath Type, Non-Sterile NNX
    Device, Cystometric, Hydraulic FEN
    Catheter, Straight EZD
    Collector, Urine, (And Accessories) For Indwelling Catheter KNX
    Kit, Nephroscope FGA
    Cystoscope And Accessories, Flexible/Rigid FAJ
    Endoscopic Access Overtube, Gastroenterology-Urology FED
    Dilator, Urethral KOE
    Cricothyrotomy Kit OGP
    Cannula, Nasal, Oxygen CAT
    Mask, Oxygen, Non-Rebreathing KGB
    Catheter, Ureteral, Gastro-Urology EYB
    Catheter, Peritoneal GBW
    Catheters, Suction, Tracheobronchial BSY
    Catheter, Irrigation GBX
    Tubes, Gastrointestinal (And Accessories) KNT
    Guide, Surgical, Instrument FZX
    Tube, Double Lumen For Intestinal Decompression And/Or Intubation FEG
    Gastrointestinal Tubes With Enteral Specific Connectors PIF
    Stylet, Tracheal Tube BSR
    Airway, Oropharyngeal, Anesthesiology CAE
    Endoscope Channel Accessory ODC
    Lavage, Jet FQH
    Tubing, Noninvasive GAZ
    Mask, Gas, Anesthetic BSJ
    Circuit, Breathing (W Connector, Adaptor, Y Piece) CAI
    Mask, Oxygen BYG
    Catheter, Urethral GBM
    Endoscopic Guidewire, Gastroenterology-Urology OCY
    Bottle, Collection, Vacuum KDQ
    Set, Tubing And Support, Ventilator (W Harness) BZO
    Tube, Tracheostomy (W/Wo Connector) BTO
    Laparoscope, General & Plastic Surgery GCJ
    Catheter And Tip, Suction JOL
    Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector) CBI
    Catheter, Suprapubic (And Accessories) KOB
    Apparatus, Suction, Single Patient Use, Portable, Nonpowered GCY
    Dislodger, Stone, Basket, Ureteral, Metal FFL
    Airway, Nasopharyngeal BTQ

    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 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 Stone Collection Bottle OXYGEN TUBING WELL LEAD OXYGEN TUBING Tracheostomy Tube Laparoscopic Retrieval Bag Well Lead Extraction Bag Endobronchial Tube All Silicone Foley Catheter with Temperature Sensor Flume Catheter Well Lead Hydrophilic Silicone Foley Catheter Silicone Reservoir Stone Retrieval Basket FLEX- TIP ORAL/NASA INTUBATION TUBE Red Rubber Catheter Nasopharyngeal Airway

    Establishment Types

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