Data / Medical devices / China / Huzhou Junda Industry Co., Ltd.
Huzhou Junda Industry Co., Ltd.: FDA-registered device maker in Anji Zhejiang, China, 14 510(k) clearances
Huzhou Junda Industry Co., Ltd. is registered with the FDA (registration 3034669683) in Anji Zhejiang, China. It lists 130 device types. The FDA files 14 510(k) clearances under its listings, the newest dated June 16, 2023. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3034669683
- Address
- F22,Building B,Anji Chamber of Commerce Mansion. No.99 Tianhuangping South Road, Anji Zhejiang, China, 313300
- Owner or operator
- HUZHOU JUNDA INDUSTRY CO., LTD. (10092052)
- Roles
- Contract manufacturer, Exporter to the US, Manufacturer
- First device listed
- November 28, 2024
- Registered through
- 2026
- Brand names listed
- 3-WAY STOPCOCK, three way stop cock, ANEROID SPHYGMOMANOMETER, ANEROID SPHYGMOMANOMETER, MODEL BK2002, Abdominal Drainage Tube, Absorbent Cotton Roll, Absorbent Under pads, Pet Pad, Nursing Pad, Adjustable Mask, Adult Diaper and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Absorber, Carbon-Dioxide | BSF | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Absorber, Saliva, Paper | KHR | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Accessories, Catheter | KGZ | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Airway, Nasopharyngeal | BTQ | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Analyzer, Chemistry, Centrifugal, For Clinical Use | JJG | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Anesthesia Breathing Circuit Kit (Adult & Pediatric) | OFP | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Applicator, Absorbent Tipped, Non-Sterile | KXF | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Apron, Protective | IWO | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Bag, Drainage, With Adhesive, Ostomy | FON | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Bag, Ice | KYR | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Bag, Urine Collection, Leg, For External Use, Sterile | FAQ | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Bandage, Cast | ITG | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Bandage, Elastic | FQM | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Bedding, Disposable, Medical | KME | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Bedpan | FOB | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Blood Pressure Cuff | DXQ | 2 | Exporter to the US | accessdata.fda.gov |
| Blood Transfusion Kit | POQ | 2 | Exporter to the US | accessdata.fda.gov |
| Bottle, Hot/Cold Water | FPF | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Brush, Scrub, Operating-Room | GEC | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Cannula, Injection | FGY | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Cannula, Nasal, Oxygen | CAT | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Cap, Surgical | FYF | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Catheter And Tip, Suction | JOL | 2 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Catheter, Balloon Type | GBA | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Catheter, Irrigation | GBX | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Catheters, Suction, Tracheobronchial | BSY | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Centrifuge, Microsedimentation | GHK | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Chair, With Casters | INM | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Cleaner, Ultrasonic, Medical Instrument | FLG | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Collector, Urine, (And Accessories) For Indwelling Catheter | KNX | 2 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Collector, Urine, Pediatric, For Indwelling Catheter | FFH | 2 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Component, Cast | LGF | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Components, Wheelchair | KNN | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Connector, Ureteral Catheter | EYK | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Container, Specimen, Non-Sterile | NNI | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Container, Specimen, Sterile | FMH | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Cotton, Roll | EFN | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Cover, Shoe, Operating-Room | FXP | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Coverslips, Microscope Slide | KES | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Crutch | IPR | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Depressor, Tongue, Non-Surgical | FMA | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Device, Fixation, Tracheal Tube | CBH | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Device, General Purpose, Microbiology, Diagnostic | LIB | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Device, Occlusion, Umbilical | FOD | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Device, Rebreathing | BYW | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Dish, Tissue Culture | KIZ | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Disinfectant, Medical Devices | LRJ | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Drape, Surgical, Antimicrobial | KKX | 2 | Exporter to the US | accessdata.fda.gov |
| Dressing, Wound, Hydrophilic | NAC | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Dressing, Wound, Occlusive | NAD | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Dye-Indicator, Ph (Urinary, Non-Quantitative) | CEN | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Elastomer, Silicone, For Scar Management | MDA | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Electrode, Electrocardiograph | DRX | 2 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Endoscopic Bite Block | MNK | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Enema Kit | FCE | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Enteral Administration Kit (Adult & Pediatric) | PRM | 2 | Exporter to the US | accessdata.fda.gov |
| Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua | QKR | N | Exporter to the US | accessdata.fda.gov |
| Fast Green | HYC | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Fiber, Medical, Absorbent | FRL | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| First Aid Kit Without Drug | OHO | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Forceps | HTD | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Forceps, Rubber Dam Clamp | EJG | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Garment, Protective, For Incontinence | EYQ | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Gastrointestinal Tubes With Enteral Specific Connectors | PIF | 2 | Exporter to the US | accessdata.fda.gov |
| Gauze / Sponge,Nonresorbable For External Use | NAB | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Gauze/Sponge, Internal, X-Ray Detectable | GDY | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Gown, Examination | FME | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Gown, Surgical | FYA | 2 | Exporter to the US | accessdata.fda.gov |
| Handle, Scalpel | GDZ | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Holder, Needle, Gastroenterologic | FHQ | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Infusor, Pressure, For I.V. Bags | KZD | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Instrument, Clip Removal | HBQ | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Instrument, Ligature Passing And Knot Tying | HCF | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Instrument, Manual, Surgical, General Use | MDM | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment | KIJ | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Marker, Skin | FZZ | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Mask, Gas, Anesthetic | BSJ | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Mask, Oxygen | BYG | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Mask, Oxygen, Low Concentration, Venturi | BYF | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Mask, Oxygen, Non-Rebreathing | KGB | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Micro Pipette | JRC | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Mixer, Blood Tube | GLE | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Mouthpiece, Saliva Ejector | DYN | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Nebulizer, Medicinal, Non-Ventilatory (Atomizer) | CCQ | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Needle, Dental | DZM | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Needle, Hypodermic, Single Lumen | FMI | 2 | Exporter to the US | accessdata.fda.gov |
| Non-Surgical Gown | OEA | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Nursing Pad, Polyurethane Pad With Starch Copolymer, Glycerin, And Surfactant (F-68) | NTX | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Orthosis, Cervical-Thoracic, Rigid | IQF | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Pack, Hot Or Cold, Disposable | IMD | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Pad, Eye | HMP | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Pad, Menstrual, Unscented | HHD | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Pipette, Pasteur | GJW | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Polymer Patient Examination Glove | LZA | 1 | Exporter to the US | accessdata.fda.gov |
| Pouch, Colostomy | EZQ | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Protector, Ostomy | EXE | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Remover, Intrauterine Device, Contraceptive, Hook-Type | HHF | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Saline, Vascular Access Flush | NGT | 2 | Exporter to the US | accessdata.fda.gov |
| Scale, Patient | FRW | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Scissors, Surgical Tissue, Dental | EGN | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Set, Administration, Intravascular | FPA | 2 | Exporter to the US | accessdata.fda.gov |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | HOY | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Shield, Protective, Personnel | KPY | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Slides, Microscope | KEW | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Sling, Arm | ILI | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Speculum, Vaginal, Nonmetal | HIB | 2 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Splint, Traction | HSP | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Staple, Removable (Skin) | GDT | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Stapler, Skin | QQS | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Stethoscope, Manual | LDE | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Support, Patient Position | CCX | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Surgeon'S Gloves | KGO | 1 | Exporter to the US | accessdata.fda.gov |
| Syringe, Irrigating (Non Dental) | KYZ | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Syringe, Piston | FMF | 2 | Exporter to the US | accessdata.fda.gov |
| Table, Operating-Room, Electrical | GDC | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Tape And Bandage, Adhesive | KGX | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Tape, Orthopedic | HXT | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Test, Cannabinoid, Employment And Insurance Testing, Exempt | PVJ | 2 | Exporter to the US | accessdata.fda.gov |
| Thermometer, Clinical Color Change | FQZ | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Toothbrush, Manual | EFW | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Tourniquet, Nonpneumatic | GAX | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Tube, Aspirating, Flexible, Connecting | BYY | 2 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Tube, Tissue Culture | KJG | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Tube, Tonsil Suction | KCB | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Tubes, Gastrointestinal (And Accessories) | KNT | 2 | Exporter to the US | accessdata.fda.gov |
| Tubing, Pressure And Accessories | BYX | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Unit, Operative Dental, Accessories | NRD | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Unit, Oral Irrigation | EFS | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Ventilator, Emergency, Manual (Resuscitator) | BTM | 2 | Exporter to the US | accessdata.fda.gov |
| Wound Dressing Kit | MCY | 2 | Contract manufacturer, Exporter to the US, 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 |
|---|---|---|---|---|---|---|
| June 16, 2023 | K222999 | Surgical Gown | FYA | Substantially Equivalent | Hubei Woozon Healthcare Co., Ltd. | accessdata.fda.gov |
| September 29, 2022 | K221637 | Surgical Gown (Sterile); Surgical Gown (Non-sterile) | FYA | Substantially Equivalent | Allmed Medical (Hubei) Protective Products Co., Ltd. | accessdata.fda.gov |
| August 30, 2022 | K212846 | Sterile Hypodermic Syringe for Single Use, with/without Needle, Sterile Hypodermic Needle for Single Use | FMF | Substantially Equivalent | Jiangsu Jichun Medical Devices Co., Ltd. | accessdata.fda.gov |
| February 1, 2021 | K203483 | Medispo Rubber Surgical Gloves, Medispo Polyisoprene Surgical Gloves | KGO | Substantially Equivalent | Guilin Hbm Health Protections, Inc. | accessdata.fda.gov |
| August 26, 2020 | K191640 | TK Intravascular Administration Set | FPA | Substantially Equivalent | Anhui Tiankang Medical Technology Co., Ltd. | accessdata.fda.gov |
| November 15, 2019 | K191784 | Gabriel Feeding Tube with Balloon, and EnFit Connector | PIF | Unknown | Syncro Medical Innovations, Inc. | accessdata.fda.gov |
| July 12, 2019 | K183473 | AMSafe(R) Pre-Filled Normal Saline Flush Syringe | NGT | Substantially Equivalent | Amsino International, Inc. | accessdata.fda.gov |
| May 30, 2018 | K173246 | ANEROID SPHYGMOMANOMETER | DXQ | Substantially Equivalent | Wenzhou Bokang Instruments Co., Ltd. | accessdata.fda.gov |
| August 3, 2012 | K121526 | POWER-FREE NITRILE PATIENT EXAMINATION GLOVES | LZA | Substantially Equivalent | Shandong Junchi Medical Products Co., Ltd. | accessdata.fda.gov |
| July 29, 2011 | K103830 | JIANGSU SHENLI MEDICAL PRODUCTION CO. LTD. PISTON SYRINGE (5CC LUER LOCK) | FMF | Substantially Equivalent | Jiangsu Shenli Medical Production Factory | accessdata.fda.gov |
| August 15, 2005 | K043015 | 3L SURGICAL DRAPES | KKX | Substantially Equivalent | 3l Medical Products Co., Ltd. | accessdata.fda.gov |
| January 13, 2005 | K043286 | ANEROID SPHYGMOMANOMETER, MODEL BK2002 | DXQ | Substantially Equivalent | Wenzhou Bokang Instrument Co.,Ltd | accessdata.fda.gov |
| May 3, 2002 | K020393 | MASTER & FRANK SURGICAL DRAPES (STERILE) | KKX | Substantially Equivalent | Master & Frank Enterprses Co., Ltd. | accessdata.fda.gov |
| February 27, 2002 | K014115 | 1ST RESPONSE MANUAL RESUSCITATOR, MODEL 85XX | BTM | Substantially Equivalent | Portex, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Brush, Scrub, Operating-Room
- All makers of Gown, Surgical
- All makers of Connector, Ureteral Catheter
- All makers of Cap, Surgical
- All makers of Stapler, Skin
- All makers of Anesthesia Breathing Circuit Kit (Adult & Pediatric)
Updated June 16, 2023. 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.