FDA Registration
Active
🇨🇳 China
HEYUAN HONG DE MEDICAL PRODUCTS CO., LTD.
Reg #: 3013429557
·
FEI: 3013429557
·
Expires 2026
Products
13
Proprietary Names
1
Establishment Types
4
Classifications
13
Registration Details
- Registration Name
- HEYUAN HONG DE MEDICAL PRODUCTS CO., LTD.
- Registration Number
- 3013429557
- FEI Number
- 3013429557
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 3rd Road Linjiang Industrial Zone, Jiangdong New Area
- City
- Heyuan City Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K221278
Owner / Operator
- Firm Name
- Heyuan Hong De Medical Products Co., Ltd.
- Operator Number
- 10052554
- Address
- 3rd Road Industrial Zone of Linjiang, Zijin County
- City
- Heyuan
- State
- Guangdong
- Postal Code
- 517001
- Country
- CN
US Agent
- Business Name
- Simcon International LLC
- Contact Name
- Rosanna Lee
- Address
- 1200 Townline Road
- City
- Mundelein
- State
- IL
- ZIP
- 60060
- Country
- US
- [email protected]
- Phone
- 847 9492290
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Cover, Shoe, Operating-Room | FXP | Class 1 | General, Plastic Surgery | No | 2016-08-15 |
| Blood Pressure Cuff | DXQ | Class 2 | Cardiovascular | No | 2016-08-15 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2016-08-15 |
| Non-Surgical Gown | OEA | Class 1 | General, Plastic Surgery | No | 2016-11-23 |
| Collector, Urine, (And Accessories) For Indwelling Catheter | KNX | Class 2 | Gastroenterology, Urology | No | 2016-08-15 |
| Basin, Emesis | FNY | Class 1 | General Hospital | No | 2017-06-15 |
| Support, Patient Position | CCX | Class 1 | Anesthesiology | No | 2023-09-07 |
| Cover, Barrier, Protective | MMP | Class 2 | General, Plastic Surgery | No | 2016-08-15 |
| Transducer, Ultrasonic, Diagnostic | ITX | Class 2 | Radiology | No | 2024-04-12 |
| Gown, Surgical | FYA | Class 2 | General, Plastic Surgery | No | 2016-08-15 |
| Drape, Surgical, Antimicrobial | KKX | Class 2 | General, Plastic Surgery | No | 2016-08-15 |
| Drape, Surgical, Exempt | PUI | Class 2 | General, Plastic Surgery | No | 2017-09-06 |
| Light, Surgical, Accessories | FTA | Class 2 | General, Plastic Surgery | No | 2023-09-07 |
Proprietary Names
COVER PROBE W/GEL & BANDS
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device
Export Device to the United States But Perform No Other Operation on Device
Repack or Relabel Medical Device