BEUDAMED
    FDA Registration Active 🇨🇳 China

    WELL LEAD MEDICAL CO. LTD

    Reg #: 3003903031 · FEI: 3003903031 · Expires 2026
    View on FDA
    Products
    23
    Proprietary Names
    45
    Establishment Types
    4
    Classifications
    23

    Registration Details

    Registration Name
    WELL LEAD MEDICAL CO. LTD
    Registration Number
    3003903031
    FEI Number
    3003903031
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    C-4 JINHU INDUSTRIAL ESTATE, HUALONG, PAN YU
    City
    GUANGZHOU Guangdong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K082815

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

    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 Wellead Endoscopic Seal Well Lead Reinforced ET Tube Reinforced Endotracheal Tube Stomach Tube Salem Sump Silicone Dual Lumen Stomach Tube with ENFit Connection Stryker 8001 Series Skin Temperature Probe MEAS 4400 Series Skin Temperature Probe MEAS 4400 Series Esophageal/Rectal Temperature Probe Stryker 8001 Series Esophageal/Rectal temperature Probe DRAIN PENROSE Portable Roller Irrigation Pump Well Lead PVC Hydrophilic Urethral Catheter DEVMED DOUBLE-BALLOON UROLOGICAL CATHETER Red Rubber Catheter

    Establishment Types

    Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer) Sterilize Medical Device for Another Party (Contract Sterilizer) Export Device to the United States But Perform No Other Operation on Device