Data / Medical devices / China / Hony Medical Co., Ltd
Hony Medical Co., Ltd: FDA-registered device maker in Taishan Guangdong, China, 3 510(k) clearances
Hony Medical Co., Ltd is registered with the FDA (registration 3013595964) in Taishan Guangdong, China. It lists 10 device types. The FDA files 3 510(k) clearances under its listings, the newest dated July 24, 2024. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3013595964
- Address
- No.12, 9 Road, Changlong Ind. Zone, Taishan Guangdong, China, 529222
- Owner or operator
- Hony Medical Co., Ltd (10053822)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- January 15, 2017
- Registered through
- 2027
- Brand names listed
- 5.C-Arm Drape;, 8 Nasal Fix Plaster, DYND16700, DYND16800, EZ-Cover, EZDrape, Endotracheal(ET) Tube Holder, Halyard Microscope Cover and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessory, Surgical Apparel | LYU | 1 | Manufacturer | accessdata.fda.gov |
| Device, Fixation, Tracheal Tube | CBH | 1 | Manufacturer | accessdata.fda.gov |
| Drape, Adhesive, Aerosol | KGT | 1 | Manufacturer | accessdata.fda.gov |
| Drape, Surgical, Exempt | PUI | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Dressing, Wound, Hydrogel Without Drug And/Or Biologic | NAE | 1 | Manufacturer | accessdata.fda.gov |
| Dressing, Wound, Hydrophilic | NAC | 1 | Manufacturer | accessdata.fda.gov |
| Holder, Ureteral Catheter | EYJ | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Media, Coupling, Ultrasound | MUI | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Tape And Bandage, Adhesive | KGX | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Transducer, Ultrasonic, Diagnostic | ITX | 2 | Contract manufacturer, 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 |
|---|---|---|---|---|---|---|
| July 24, 2024 | K241789 | Non-Sterile Ultrasound Transmission Gels | MUI | Substantially Equivalent | Hony Medical Co., Ltd. | accessdata.fda.gov |
| July 3, 2024 | K241615 | Transducer Probe Cover | ITX | Substantially Equivalent | Hony Medical Co., Ltd. | accessdata.fda.gov |
| January 11, 2023 | K221278 | Transducer Probe Cover | ITX | Substantially Equivalent | Hony Medical Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Media, Coupling, Ultrasound
- All makers of Holder, Ureteral Catheter
- All makers of Drape, Adhesive, Aerosol
- All makers of Dressing, Wound, Hydrophilic
- All makers of Transducer, Ultrasonic, Diagnostic
- All makers of Drape, Surgical, Exempt
Updated July 24, 2024. 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.