FDA Registration
Active
🇨🇳 China
Hongyu Biotech (ShenZhen) Co., Ltd.
Reg #: 3017107376
·
FEI: 3017107376
·
Expires 2026
Products
14
Proprietary Names
26
Establishment Types
2
Classifications
14
Registration Details
- Registration Name
- Hongyu Biotech (ShenZhen) Co., Ltd.
- Registration Number
- 3017107376
- FEI Number
- 3017107376
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 10A,Finance Center, No.22 Taizi Road, Nanshan District
- City
- Shenzhen Guangdong
- Country
- CN
Owner / Operator
- Firm Name
- Hongyu Biotech (ShenZhen) Co., Ltd.
- Operator Number
- 10079513
- Address
- 10A,Finance Center, No.22 Taizi Road, Nanshan District
- City
- Shenzhen
- State
- Guangdong
- Postal Code
- 518067
- Country
- CN
- Correspondent
- Shumiao Yang
US Agent
- Business Name
- Regrek LLC
- Contact Name
- Leeyeo Kee
- Address
- 19 Holly Cove Ln.
- City
- Dover
- State
- DE
- ZIP
- 19901
- Country
- US
- [email protected]
- Phone
- 302 6089028
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Cover, Cast | KIA | Class 1 | General Hospital | No | 2024-08-09 |
| Strip, Adhesive, Closure, Skin | FPX | Class 1 | General Hospital | No | 2024-12-23 |
| Stocking, Medical Support (For General Medical Purposes) | FQL | Class 1 | General Hospital | No | 2023-02-21 |
| Gauze / Sponge,Nonresorbable For External Use | NAB | Class 1 | General, Plastic Surgery | No | 2020-12-10 |
| Dilator, Nasal | LWF | Class 1 | Ear, Nose, Throat | No | 2023-02-21 |
| Adaptor, Hygiene | ILS | Class 1 | Physical Medicine | No | 2023-02-21 |
| Walker, Mechanical | ITJ | Class 1 | Physical Medicine | No | 2023-02-21 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2020-12-10 |
| Dressing, Wound, Hydrophilic | NAC | Class 1 | General, Plastic Surgery | No | 2020-12-10 |
| Elastomer, Silicone, For Scar Management | MDA | Class 1 | General, Plastic Surgery | No | 2020-12-10 |
| Dressing, Wound, Drug | FRO | Class U | Unknown | No | 2023-06-04 |
| Dressing, Wound, Occlusive | NAD | Class 1 | General, Plastic Surgery | No | 2020-12-10 |
| Tips And Pads, Cane, Crutch And Walker | INP | Class 1 | Physical Medicine | No | 2023-02-21 |
| Disinfectant, Medical Devices | LRJ | Class 1 | General Hospital | No | 2020-12-10 |
Proprietary Names
Cast Cover
Wound Closure Strip
Medical compression sock
PVA Bandages
PVA Swabs
PVA Sponges
Nasal strips
Shower Safety Seating
Folding Walker
Non-woven Tape; non-woven surgical tape; PE Tape; transparent surgical tape; I.V Dressing; Silicone Tape
Surgical Tape; Foam Tape PVC; Elastic Bandages; Athletic Tape; Bandage
Transparent Film Dressing, Alginate Dressings, Film Island Dressing, Non-woven Adhesive Wound Dressing with pad,
Foam dressing, Super Absorbent Dressing, Hydrocolloid Dressing, Adhesive Island Dressing, Nasal Strips, Acne Patch,
Hydrocolloid Gel Bandages
Scar Gel
silicone scar sheet
Silicone Dressing
Silicone Tape
Hydrophilic wound dressing
Silicone Gel Sheeting
Silver Alginate Dressing
Trap Door Dressing (NAD Dressing, wound, occlusive), Silicone Contact Layer, Petrolatum Gauze Dressing
Cane
Disinfectant
Alcohol Prep Pad/Cleansing Pads
Medical Devices
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device for Another Party (Contract Manufacturer)