Huzhou Junda Industry Co., Ltd.
Manufacturer and brand owner in Anji, Zhejiang, China. 129 device types, 10 products catalogued.
Huzhou Junda Industry Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Bedpan, Crutch and 127 other device types. 10 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2024.
129device types registered with the FDA
10products catalogued under its own name
Registration
| Registered name | HUZHOU JUNDA INDUSTRY CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3034669683 |
| FEI number | 3034669683 |
| DUNS | 452976115 |
| Establishment type | Contract manufacturer, Manufacturer, Exporter |
Chinese Registration
| Chinese legal name | 湖州骏达医疗用品有限公司 |
|---|---|
| Source | Qichacha company register |
Location
| City | Anji |
|---|---|
| Province | Zhejiang |
| Address | F22,Building B,Anji Chamber of Commerce Mansion. No.99 Tianhuangping South Road |
| Postal code | 313300 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Absorber, Carbon-Dioxide | Class 1 | Soda LIME CO2 ABSORBENT GRANULES | 2024 | 6 |
| Absorber, Saliva, Paper | Class 1 | Dental bibs | 2024 | 86 |
| Accessories, Catheter | Class 1 | 3-WAY STOPCOCK, three way stop cock | 2024 | 33 |
| Airway, Nasopharyngeal | Class 1 | Guedel Airway, Laryngeal Mask Airway, disposable laryngeal mask, Nasal Airway | 2024 | 52 |
| Analyzer, Chemistry, Centrifugal, For Clinical Use | Class 1 | sample cup, HEPARIN CAP | 2024 | 3 |
| Anesthesia Breathing Circuit Kit (Adult & Pediatric) | Class 1 | Disposable Breathing Circuits | 2024 | 11 |
| Applicator, Absorbent Tipped, Non-Sterile | Class 1 | Tipped Applicator, Cotton Swabs, Transport Swab, Wooden Applicator Stick | 2024 | 186 |
| Apron, Protective | Class 1 | PE Apron, CPE Apron, PVC Apron, Non-woven Apron | 2024 | 46 |
| Bag, Drainage, With Adhesive, Ostomy | Class 1 | Ostomy Bag | 2024 | 49 |
| Bag, Ice | Class 1 | Ice Bag | 2024 | 86 |
| Bag, Urine Collection, Leg, For External Use, Sterile | Class 1 | Leg bag | 2024 | 52 |
| Bandage, Cast | Class 1 | i.v dressing plaster | 2024 | 81 |
| Bandage, Elastic | Class 1 | Elastic Adhesive Bandage, Cohesive Bandage, Elastic Bandages with Self Closure, Elastic bandage,Tubular bandage,Plaster Of Paris Bandage | 2024 | 280 |
| Bedding, Disposable, Medical | Class 1 | High Vac Aspiration Tubing, Back Table Cover, Examination couch pads, Examination rolls, pillow cover, Disposable bed sheets, Bed Cover, Body Bag, Emergency Blanket, Table Drape | 2024 | 308 |
| Bedpan | Class 1 | Bedpan | 2024 | 34 |
| Blood Pressure Cuff | Class 2 | Aneroid Sphygmomanometer, Aneroid Sphygmomanometer, Model BK2002 | 2026 | 50 |
| Blood Transfusion Kit | Class 2 | Disposable Blood transfusion set | 2024 | 1 |
| Bottle, Hot/Cold Water | Class 1 | Hot Water Bag | 2024 | 37 |
| Brush, Scrub, Operating-Room | Class 1 | Surgical Scrub Brush, Cleaning Ball | 2024 | 42 |
| Cannula, Injection | Class 1 | I.V. Cannula | 2024 | 12 |
| Cannula, Nasal, Oxygen | Class 1 | Nasal Cannula, Nasal Oxygen Cannula, Nassal oxygen cannula | 2024 | 97 |
| Cap, Surgical | Class 1 | Combi cap, Nurse Cap, Doctor Cap, Surgical Cap,bouffant cap,clip cap, Mob cap, Surgeon Caps (TIE-ON-STYLE) – BLUE, Surgeon Cap | 2024 | 178 |
| Catheter And Tip, Suction | Class 2 | Wound Suction Set, Negative Pressure Suction Ball, Thoracic Cavity Drainage Bottle, Suction Connecting set, Suction Catheter, Yankauer Suction Set | 2024 | 70 |
| Catheter, Balloon Type | Class 1 | Silicone Drainage Kit, Closed Wound Drainage System | 2025 | 4 |
| Catheter, Irrigation | Class 1 | Feeding bag set | 2024 | 24 |
| Catheters, Suction, Tracheobronchial | Class 1 | medidrain ( wound suction drainage system ), Tracheobronchial Tube, Thorax drain bottle, Endoracheal tube, Extension tube, Centum Lumen Catheter( Double, Triple) | 2024 | 93 |
| Centrifuge, Microsedimentation | Class 1 | Centrifuge Tube | 2024 | 7 |
| Chair, With Casters | Class 1 | stroller, Drug Trolley | 2024 | 85 |
| Cleaner, Ultrasonic, Medical Instrument | Class 1 | ultrasound knife | 2024 | 48 |
| Collector, Urine, (And Accessories) For Indwelling Catheter | Class 2 | Urine bag, silicone foley ballon catheter, Latex foley ballon catheter, Latex exteranal malecatheter | 2024 | 51 |
| Collector, Urine, Pediatric, For Indwelling Catheter | Class 2 | Urine Pediatric, Urine collector | 2024 | 11 |
| Component, Cast | Class 1 | Stockinet, Orthopedic padding, Undercast Padding | 2024 | 22 |
| Components, Wheelchair | Class 1 | stretcher, Wheelchairs | 2024 | 54 |
| Connector, Ureteral Catheter | Class 1 | Nelaton catheter | 2024 | 2 |
| Container, Specimen, Non-Sterile | Class 1 | Urine Container, Stool Container | 2024 | 115 |
| Cotton, Roll | Class 1 | Zig-Zag Cotton Wool, Cotton Pad, Cotton Ball, Absorbent Cotton Roll | 2024 | 107 |
| Cover, Shoe, Operating-Room | Class 1 | Shoe cover,Boot cover, Sleeve Cover | 2024 | 176 |
| Coverslips, Microscope Slide | Class 1 | Coverslips | 2024 | 32 |
| Crutch | Class 1 | Walking aids, Crutches, Canes | 2024 | 112 |
| Depressor, Tongue, Non-Surgical | Class 1 | Tongue Depressor | 2024 | 100 |
| Device, Fixation, Tracheal Tube | Class 1 | Reinforced Endotracheal Tube, Endotracheal Tube, Endotracheal Tube – Cuffed | 2024 | 46 |
| Device, General Purpose, Microbiology, Diagnostic | Class 1 | HCG Pregnancy Test Strip | 2024 | 7 |
| Device, Occlusion, Umbilical | Class 1 | Umbilical Cord Clamp | 2024 | 18 |
| Device, Rebreathing | Class 1 | Oxygenerator | 2024 | 13 |
| Dish, Tissue Culture | Class 1 | Petri Dish | 2024 | 30 |
| Disinfectant, Medical Devices | Class 1 | Alcohol Pad, Alcohol Swabs, Povidone-Iodine Pad, Bzk Antiseptic Pad, Antiseptic Cleaning Wipe | 2024 | 197 |
| Drape, Surgical, Antimicrobial | Class 2 | Ophthalmic Drape, Surgical drape with hole, Surgical drapes pack (by-pass drape set) | 2024 | 39 |
| Dressing, Wound, Hydrophilic | Class 1 | Alginate Dressing, Foam Dressing Set, Hydrophilic Dressing, I.V. Dressing, Hydrogel Dressing, Sterile Non-adherent pads | 2024 | 195 |
| Dressing, Wound, Occlusive | Class 1 | First Aid Plaster, Super Absorbency Dressing; Ultra Thin Absorbent Film, PU surgical film, Vaseline gauze, Observation film, Foam Dressing; Hydrocolloid Dressing; Hydrocolloid Foam Dressing; Nonwoven wound dressing; Silicone Dressing; | 2024 | 183 |
| Dye-Indicator, Ph (Urinary, Non-Quantitative) | Class 1 | Autoclave Indicator Tape, EO Indicator Tape | 2024 | 16 |
| Elastomer, Silicone, For Scar Management | Class 1 | Silicone Scar Sheet | 2024 | 85 |
| Electrode, Electrocardiograph | Class 2 | Electrosurgical pencill, ECG Electrode, Blayco (pregelled Electrosurgical plate), Monitor, Electrode pencil, ECG chest Electrode, ESU Plate | 2024 | 33 |
| Endoscopic Bite Block | Class 1 | Dental pads | 2024 | 44 |
| Enema Kit | Class 1 | Enema bag | 2024 | 24 |
| Enteral Administration Kit (Adult & Pediatric) | Class 2 | Stomach Tube | 2024 | 7 |
| Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua | Class N | Face Mask, Disposable Surgical Mask, Kn95 Mask, Non-Woven Face Mask | 2024 | 182 |
| Fast Green | Class 1 | Cervical Scraper, cervical sampler, Cervical Brush | 2024 | 2 |
| Fiber, Medical, Absorbent | Class 1 | Non-woven swabs (sterile/non sterile) | 2024 | 172 |
| First Aid Kit Without Drug | Class 1 | First Aid Bag | 2024 | 132 |
| Forceps | Class 1 | Tweezers, Hemostatic forceps, Surgical forceps | 2024 | 99 |
| Forceps, Rubber Dam Clamp | Class 1 | Facial feature checker, Examination lamp | 2024 | 7 |
| Garment, Protective, For Incontinence | Class 1 | Adult diapers, Baby Diaper, Pet Diaper, Adult Diaper | 2024 | 181 |
| Gastrointestinal Tubes With Enteral Specific Connectors | Class 2 | Feeding tube | 2024 | 17 |
| Gauze / Sponge,Nonresorbable For External Use | Class 1 | Lap Sponges, Abdominal pads, Gauze abdominal Roll, Soluble hemostatic gauze, Absorbent Gauze Roll, Gauze Pad | 2024 | 266 |
| Gauze/Sponge, Internal, X-Ray Detectable | Class 1 | Surgical Sterile Laparotomy Sponges, Surgical Laparotomy Sponges, Gauze Bandage With X-Ray, Gauze Roll With X-Ray, Gauze Zig-Zag With X-Ray, Gauze Cutting With X-Ray, Gauze Swabs, Gauze Balls, Gauze Bandage, Gauze Roll, Gauze Zig-Zag, Gauze Cutting, Laparotomy Sponges With X-Ray, Gauze Swabs With X-Ray, Gauze Balls With X-Ray, Surgical Sponges | 2024 | 67 |
| Gown, Examination | Class 1 | Exam Gown, surgical Gown, Reinforce Surgical Gown, Surgeon Gown | 2024 | 109 |
| Gown, Surgical | Class 2 | Surgical Gown, Non woven Surgical gown | 2024 | 68 |
| Handle, Scalpel | Class 1 | Surgical blade, Surgical handle | 2024 | 29 |
| Holder, Needle, Gastroenterologic | Class 1 | Blood Lancet, Lancing Device, Vacuum Blood Collection Tube | 2024 | 8 |
| Infusor, Pressure, For I.V. Bags | Class 1 | PVC infusion bag | 2024 | 25 |
| Instrument, Clip Removal | Class 1 | Applicable Clip Applier | 2024 | 5 |
| Instrument, Ligature Passing And Knot Tying | Class 1 | Disposable Fascial Closure Systems | 2024 | 8 |
| Instrument, Manual, Surgical, General Use | Class 1 | Self-sealing Sterilization Pouch, Flat Sterilization Roll, Wrapping Creap Paper, Heat sealing sterilization flat reel | 2024 | 110 |
| Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment | Class 1 | Sphygmomanometer/Digital Blood Pressure Monitor, B.P. Cuff | 2024 | 10 |
| Marker, Skin | Class 1 | ID bracelet; identification band, Identification Bracelet | 2024 | 55 |
| Mask, Gas, Anesthetic | Class 1 | Anesthesia Mask, PVC anesthesia face mask, Breathing and Anesthe sia Circuit | 2024 | 71 |
| Mask, Oxygen | Class 1 | Nebulizer Mask, Tracheostomy Tube, Simple Oxygen Mask, Oxygen Regul ator, Tracheostomy masks, Nebulizer Machen | 2024 | 126 |
| Mask, Oxygen, Low Concentration, Venturi | Class 1 | Venturi Mask, Adjustable Mask | 2024 | 46 |
| Mask, Oxygen, Non-Rebreathing | Class 1 | Oxygen Mask, CPR MASK | 2024 | 72 |
| Micro Pipette | Class 1 | Micro Pipette, Pasteur Pipette | 2024 | 29 |
| Mixer, Blood Tube | Class 1 | Blood Mixer | 2024 | 8 |
| Mouthpiece, Saliva Ejector | Class 1 | Dental Saliva Ejector | 2024 | 68 |
| Nebulizer, Medicinal, Non-Ventilatory (Atomizer) | Class 1 | Nebulizers | 2024 | 57 |
| Needle, Dental | Class 1 | Dental Irrigation Needle, spinal needle, Scalp needles, Epidural Anesthesia Needle, Dental needles, Spinal Anesthesia Needle and 3 more | 2024 | 56 |
| Needle, Hypodermic, Single Lumen | Class 2 | Disposable sterile syringes, Disposable sterile Hypodermic needles | 2024 | 71 |
| Non-Surgical Gown | Class 1 | Isolation gown, Lab coat, Coverall, PE Gown | 2024 | 318 |
| Nursing Pad, Polyurethane Pad With Starch Copolymer, Glycerin, And Surfactant (F-68) | Class 1 | Absorbent Under pads, Pet Pad, Nursing Pad | 2024 | 48 |
| Orthosis, Cervical-Thoracic, Rigid | Class 1 | Foam Collar, Plastic Collar | 2024 | 30 |
| Pack, Hot Or Cold, Disposable | Class 1 | Cold Pack, Hot Pack, Cooling Gel Patch | 2024 | 176 |
| Pad, Eye | Class 1 | Eye Pad | 2024 | 100 |
| Pad, Menstrual, Unscented | Class 1 | Sanitary Napkin | 2024 | 132 |
| Pipette, Pasteur | Class 1 | Pipette, Pipette Tip, Pipette Tip Box | 2024 | 20 |
| Polymer Patient Examination Glove | Class 1 | Medical gloves | 2024 | 83 |
| Pouch, Colostomy | Class 1 | colostomy bag,colostomy pouch,Urostomy bag | 2024 | 25 |
| Protector, Ostomy | Class 1 | Hydrocolloid Skin Protective Ring, Hydrocolloid Skin Barrier, Skin Protective Paste, Skin Protective Powder, Protective Dressing Wipe, Anti-Leakage Strip | 2024 | 33 |
| Remover, Intrauterine Device, Contraceptive, Hook-Type | Class 1 | Amnio Hook | 2024 | 6 |
| Saline, Vascular Access Flush | Class 2 | Blood bag | 2024 | 10 |
| Scale, Patient | Class 1 | Weight and Height Scale, Stature Meter, BMI Measuring Tape | 2024 | 25 |
| Scissors, Surgical Tissue, Dental | Class 1 | Surgical scissors | 2024 | 6 |
| Set, Administration, Intravascular | Class 2 | Disposable infusion set | 2024 | 49 |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | Class 1 | Disposable Goggles, Face Shield | 2024 | 384 |
| Shield, Protective, Personnel | Class 1 | Face Shield | 2024 | 78 |
| Slides, Microscope | Class 1 | Microscope Slide | 2024 | 26 |
| Sling, Arm | Class 1 | Triangular Bandage, Arm Sling | 2024 | 126 |
| Speculum, Vaginal, Nonmetal | Class 2 | Vaginal Speculum | 2024 | 40 |
| Splint, Traction | Class 1 | Orthopedic Splint | 2024 | 27 |
| Staple, Removable (Skin) | Class 1 | Disposable Skin Remover | 2024 | 20 |
| Stapler, Skin | Class 1 | Disposable Skin Stapler, skin stapler | 2024 | 22 |
| Stethoscope, Manual | Class 1 | Stethoscope, Aneroid Sphygmomanometer | 2024 | 64 |
| Support, Patient Position | Class 1 | Leg Support, Knee Support, Ankle Support, Elbow Support, Wrist Support, All finger gloves Support, Reinforced wrist Support, Reinforced waist Support, Reinforced hand Support, Bracket knee Support, Bracket waist Support, Reinforced ankle Support, Cervical collars, Neck braces, Hand Support, Finger Support, Waist Support, Shoulder Support | 2024 | 66 |
| Surgeon’S Gloves | Class 1 | Surgical Gloves | 2024 | 10 |
| Syringe, Irrigating (Non Dental) | Class 1 | Vaginal Irrigation Set | 2024 | 110 |
| Syringe, Piston | Class 2 | Disposable Syrings(1,3,5,10,20,50,60 ML), Disposable sterile syringes, Disposable sterile Hypodermic needles | 2024 | 60 |
| Table, Operating-Room, Electrical | Class 1 | Operating stools, Mattresses, Sharp Container, Sterile bed, Air Mattress, Baby Bed, surgical bed, examination bed, Medical cabinets, Wash sink, Traction beds, Traction furniture, hospital bed, nursing bed, children’s bed, Drug racks, Folding screens, Infusion chairs, Iv Stand, Waiting-room bench | 2024 | 29 |
| Tape And Bandage, Adhesive | Class 1 | Kinesiology Tape, Silicone Tape, Medical tape, Hydrocolloid foot patches, plaster silk tape, Non Woven dressing tape, Fix Dressing tape, Sterile Adhesive Wound dressing tape, PE Tape | 2024 | 353 |
| Tape, Orthopedic | Class 1 | Orthopedic Casting Tape | 2024 | 8 |
| Test, Cannabinoid, Employment And Insurance Testing, Exempt | Class 2 | Disposable Tracers | 2024 | 12 |
| Thermometer, Clinical Color Change | Class 1 | Thermometer, Infrared Ear Thermometer | 2024 | 15 |
| Toothbrush, Manual | Class 1 | Pet brush, Bamboo toothbrush | 2026 | 244 |
| Tourniquet, Nonpneumatic | Class 1 | Tourniquet | 2024 | 124 |
| Tube, Aspirating, Flexible, Connecting | Class 2 | Aspiration Tubing, Infiltration Tubing, Yankauer Handle, Suction Connecting Tubing, Suction Connection Tubing, Infiltration Tubing for Peristaltic Pump | 2024 | 51 |
| Tube, Tissue Culture | Class 1 | Test Tube, Stopper(Various color), Freezing Tube | 2024 | 12 |
| Tube, Tonsil Suction | Class 1 | Baby suction tubes | 2024 | 6 |
| Tubes, Gastrointestinal (And Accessories) | Class 2 | Feeding tube | 2024 | 25 |
| Tubing, Pressure And Accessories | Class 1 | Abdominal Drainage Tube, Oxygen cannection tubing, Thoracic Duct Drainage Tube | 2024 | 45 |
| Unit, Operative Dental, Accessories | Class 1 | Sleeve sleeves | 2024 | 65 |
| Unit, Oral Irrigation | Class 1 | Disposable irrigator | 2024 | 128 |
| Ventilator, Emergency, Manual (Resuscitator) | Class 2 | Manual Resuscitator | 2024 | 8 |
| Wound Dressing Kit | Class 2 | Wound Dressing, Wound Plaster, Non-woven adhesive wound plaster dressings, Special shaped wound plaster | 2024 | 12 |
Own-Brand Listings
Clearances
No clearance names Huzhou Junda Industry Co., Ltd. as applicant. 14 are held by other companies and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K222999 | 2023-06-16 | FYA | Traditional | Hubei Woozon Healthcare Co., Ltd. |
| K221637 | 2022-09-29 | FYA | Traditional | Allmed Medical (Hubei) Protective Products Co., Ltd. |
| K212846 | 2022-08-30 | FMF | Traditional | Jiangsu Jichun Medical Devices Co., Ltd. |
| K203483 | 2021-02-01 | KGO | Traditional | Guilin HBM Health Protections, Inc. |
| K191640 | 2020-08-26 | FPA | Traditional | Anhui Tiankang Medical Technology Co., Ltd. |
| K191784 | 2019-11-15 | PIF | Traditional | Syncro Medical Innovations, Inc. |
| K183473 | 2019-07-12 | NGT | Traditional | Amsino Medical Inc. |
| K173246 | 2018-05-30 | DXQ | Abbreviated | Wenzhou Bokang Instruments Co., Ltd. |
| K121526 | 2012-08-03 | LZA | Traditional | Shandong Junchi Medical Products Co., Ltd. |
| K103830 | 2011-07-29 | FMF | Abbreviated | Jiangsu Shenli Medical Production Factory |
| K043015 | 2005-08-15 | KKX | Traditional | 3l Medical Products Co., Ltd. |
| K043286 | 2005-01-13 | DXQ | Traditional | Wenzhou Bokang Instrument Co., Ltd. |
| K020393 | 2002-05-03 | KKX | Traditional | Master & Frank Enterprses Co., Ltd. |
| K014115 | 2002-02-27 | BTM | Traditional | Portex, Inc. |
Nearby Manufacturers
| Manufacturer | Device types |
|---|---|
| Anji Hengfeng Sanitary Material Co., Ltd. | 20 |
| Zhejiang Protect Medical Equipment Co., Ltd. | 16 |
| Anji Fang Yuan Sanitary Material Co., Ltd. | 13 |
| Anji Sanfang Medical Device Co., Ltd. | 3 |
| Zhejiang Meimin Furniture Technology Co., Ltd. | 2 |
| Anji Sukar Furniture Co., Ltd. | 2 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.