Hony Medical Co., Ltd.
Registered establishment in Taishan, Guangdong, China. 10 device types, 4 clearances.
Hony Medical Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Drape, Surgical, Exempt, Drape, Adhesive, Aerosol and 8 other device types. Its earliest product listing with the FDA dates from 2017.
10device types registered with the FDA
4510(k) clearances
Registration
| Registered name | HONY MEDICAL CO., LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3013595964 |
| FEI number | 3013595964 |
| Establishment type | Contract manufacturer, Manufacturer |
Chinese Registration
| Chinese legal name | 台山市弘毅医疗用品有限公司 |
|---|---|
| Unified social credit code | 91440781090117236X |
| Source | export sales certificate, Guangdong medical products administration |
Location
| City | Taishan |
|---|---|
| Province | Guangdong |
| Address | No.12, 9 Road, Changlong Ind. Zone |
| Postal code | 529222 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Accessory, Surgical Apparel | Class 1 | Sterile Instrument Cover: Mode l. C-arm Cover ; Model 2. Ultrasound probe Cover; Model 3. Camera cover; Model 4. Microscope cover., 5.C-Arm Drape; | 2017 | 439 |
| Device, Fixation, Tracheal Tube | Class 1 | Tracheostomy Tube Holder, Endotracheal(ET) Tube Holder | 2025 | 46 |
| Drape, Adhesive, Aerosol | Class 1 | Model 1, Incise Drape; Model 2. Surgical film; Model 3. Eye drape. | 2017 | 12 |
| Drape, Surgical, Exempt | Class 2 | Microscope Cover, EZDrape, Microscope Drape, Halyard Microscope Cover | 2024 | 107 |
| Dressing, Wound, Hydrogel Without Drug And/Or Biologic | Class 1 | Hydrogel Dressing;Hydrogel Plaster | 2022 | 118 |
| Dressing, Wound, Hydrophilic | Class 1 | Model 5.Catheter Securement Device; Model 6.Trachesotomy Tube Holder; Model 7.Tracheal compress;, Model 17. Foam dressing; Model 18. Alginate dressing; Model 19. Silver dressing; Model 20. Silicone non woven dressing., Model 8. I.V. Fixation dressing; Model9.Non adherent dressing pad; Model 10. Hydrocolloid Dressing;, Model 1. Island Film Dressing; Model 2. Island Non Woven Dressing; Model 3. Eye pad; Model 4. Plastic bandage;, Model 14. Wound visible; Model 15. Silicone non woven dressing; Model 16. Foam dressing;, Model 11. Silicone adhesive foam dressing; Model 12. Silicone adhesive foam dressing; Model 13. Nasal fix plaster; and 1 more | 2017 | 195 |
| Holder, Ureteral Catheter | Class 1 | DYND16700, DYND16800, Urosecure | 2021 | 29 |
| Media, Coupling, Ultrasound | Class 2 | Non-Sterile Ultrasound Transmission Gels, Ultrasound Transmission Gels | 2022 | 8 |
| Tape And Bandage, Adhesive | Class 1 | Model 4. PE tape; Model 5. Paper tape; Model 6. Silk Tape, Model 7 Zinc Oxide Tape, 8 Nasal Fix Plaster, Mode l. Silicone tape; Model 2. Non Woven Surgic-Fix Model 3. Film Surgic-Fix; | 2017 | 353 |
| Transducer, Ultrasonic, Diagnostic | Class 2 | EZ-Cover, Ultrasound Transducer Cover, Transducer Probe Cover | 2023 | 44 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K241789 | 2024-07-24 | MUI | Traditional | This company |
| K241615 | 2024-07-03 | ITX | Special | This company |
| K221278 | 2023-01-11 | ITX | Traditional | This company |
| K221999 | 2022-08-30 | MUI | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 1998 |
|---|---|
| Factory area | 20000 square meters |
| Main products | Silicone foam dressing, Hydrogel dressing, Hydrocolloid dressing, Alginate dressing, Fixation dressing |
| Certifications | ISO13485, FDA, CE |
| Export markets | Global |
| OEM and ODM | Offered |
Nearby Manufacturers
| Manufacturer | Device types |
|---|---|
| Carmelton Jiangmen Healthcare Limited | 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.