FDA Registration
Active
🇨🇳 China
HONY MEDICAL CO., LTD
Reg #: 3013595964
·
FEI: 3013595964
·
Expires 2026
Products
10
Proprietary Names
28
Establishment Types
2
Classifications
10
Registration Details
- Registration Name
- HONY MEDICAL CO., LTD
- Registration Number
- 3013595964
- FEI Number
- 3013595964
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No.12, 9 Road, Changlong Ind. Zone
- City
- Taishan Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K241789
Owner / Operator
- Firm Name
- Hony Medical Co., Ltd
- Operator Number
- 10053822
- Address
- No.12, 9 Road, Changlong Ind. Zone
- City
- Taishan
- State
- Guangdong
- Postal Code
- 529222
- Country
- CN
- Correspondent
- Huina Zhu
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Drape, Surgical, Exempt | PUI | Class 2 | General, Plastic Surgery | No | 2024-08-29 |
| Holder, Ureteral Catheter | EYJ | Class 1 | Gastroenterology, Urology | No | 2021-07-15 |
| Transducer, Ultrasonic, Diagnostic | ITX | Class 2 | Radiology | No | 2024-09-22 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2017-01-15 |
| Dressing, Wound, Hydrogel Without Drug And/Or Biologic | NAE | Class 1 | General, Plastic Surgery | No | 2022-01-07 |
| Device, Fixation, Tracheal Tube | CBH | Class 1 | Anesthesiology | No | 2025-05-15 |
| Media, Coupling, Ultrasound | MUI | Class 2 | Radiology | No | 2025-01-24 |
| Drape, Adhesive, Aerosol | KGT | Class 1 | General, Plastic Surgery | No | 2017-01-15 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2017-01-15 |
| Dressing, Wound, Hydrophilic | NAC | Class 1 | General, Plastic Surgery | No | 2017-01-15 |
Proprietary Names
Microscope Cover
Halyard Microscope Cover
EZDrape
Microscope Drape
UROSECURE
DYND16700
DYND16800
Ultrasound Transducer Cover
EZ-Cover
Mode l . Silicone tape; Model 2. Non Woven Surgic-Fix Model 3. Film Surgic-Fix;
Model 4. PE tape; Model 5. Paper tape; Model 6. Silk Tape, Model 7 Zinc Oxide Tape
8 Nasal Fix Plaster
Hydrogel Dressing;Hydrogel Plaster
Endotracheal(ET) Tube Holder
Tracheostomy Tube Holder
Non-Sterile Ultrasound Transmission Gels
Transducer Probe Cover
Model 1, Incise Drape; Model 2. Surgical film; Model 3. Eye drape.
Ultrasound Transmission Gels
5.C-Arm Drape;
Sterile Instrument Cover: Mode l . C-arm Cover ; Model 2. Ultrasound probe Cover; Model 3. Camera cover; Model 4. Microscope cover.
Model 8. I.V. Fixation dressing; Model9.Non adherent dressing pad; Model 10. Hydrocolloid Dressing;
Model 5.Catheter Securement Device; Model 6.Trachesotomy Tube Holder; Model 7.Tracheal compress;
Model 21: Endotracheal Tube Fastener
Model 11. Silicone adhesive foam dressing; Model 12. Silicone adhesive foam dressing; Model 13. Nasal fix plaster;
Model 1. Island Film Dressing; Model 2. Island Non Woven Dressing; Model 3. Eye pad; Model 4. Plastic bandage;
Model 17. Foam dressing; Model 18. Alginate dressing; Model 19. Silver dressing; Model 20. Silicone non woven dressing.
Model 14. Wound visible; Model 15. Silicone non woven dressing; Model 16. Foam dressing;
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device