FDA Registration
Active
🇨🇳 China
Wenzhou Shengkai Technology Industry Co.,Ltd
Reg #: 3016861904
·
FEI: 3016861904
·
Expires 2026
Products
18
Proprietary Names
25
Establishment Types
2
Classifications
18
Registration Details
- Registration Name
- Wenzhou Shengkai Technology Industry Co.,Ltd
- Registration Number
- 3016861904
- FEI Number
- 3016861904
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No.2 Hongye Road, Cangnan Jinxiang town
- City
- Wenzhou city Zhejiang
- Country
- CN
Owner / Operator
- Firm Name
- Wenzhou Shengkai Technology Industry Co.,Ltd
- Operator Number
- 10065226
- Address
- No.2 Hongye Road, Cangnan Jinxiang town
- City
- Wenzhou city
- State
- Zhejiang
- Postal Code
- 325805
- Country
- CN
- Correspondent
- Dejia zhang
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 |
|---|---|---|---|---|---|
| Tourniquet, Nonpneumatic | GAX | Class 1 | General, Plastic Surgery | No | 2023-09-12 |
| First Aid Kit Without Drug | OHO | Class 1 | General, Plastic Surgery | No | 2020-03-28 |
| Pack, Hot Or Cold, Disposable | IMD | Class 1 | Physical Medicine | No | 2023-09-12 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2020-03-28 |
| Adhesive Backed Thermal Skin Patches | OMW | Class 1 | Physical Medicine | No | 2023-09-12 |
| Non-Surgical Gown | OEA | Class 1 | General, Plastic Surgery | No | 2020-03-28 |
| Bedding, Disposable, Medical | KME | Class 1 | General Hospital | No | 2020-03-28 |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | HOY | Class 1 | Ophthalmic | No | 2020-03-28 |
| Bandage, Cast | ITG | Class 1 | Physical Medicine | No | 2023-09-12 |
| Bandage, Elastic | FQM | Class 1 | General Hospital | No | 2023-09-12 |
| Disinfectant, Medical Devices | LRJ | Class 1 | General Hospital | No | 2020-03-28 |
| Pad, Eye | HMP | Class 1 | General, Plastic Surgery | No | 2023-09-12 |
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 2023-09-12 |
| Applicator, Absorbent Tipped, Non-Sterile | KXF | Class 1 | General Hospital | No | 2023-09-12 |
| Dressing, Wound, Occlusive | NAD | Class 1 | General, Plastic Surgery | No | 2023-09-12 |
| Pad, Alcohol, Device Disinfectant | LKB | Class U | Unknown | No | 2020-03-28 |
| Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua | QKR | Class N | Unknown | No | 2020-03-28 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2023-09-12 |
Proprietary Names
Tactical Tourniquet, tourniquet
First aid kit
Compress/pack, heat pack, ice pack
Face mask, Disposable face mask, Face shield, life Hammer, emergency tent
Cooling gel sheet
Protective clothing, Disposable isolation suit
Emergency blanket,Emergency sleeping bag,Emergency bivvy,Emergency tube tent
Emergency poncho
Goggles
Self adhesive elastic bandage/PBT Elastic Bandage, triangular bandage
Tactical Bandage, elastic bandage
Wet wipes/Wet tissue, Cleansing wipes,Disposable cleaning prep pad, Lens wipes, Lens cleaning wipes,Glasses wet wipes,
Antibacterial delay wet wipes, Delay spray wipes
Glasses cleaning tissue,Optical lens wipes, Camera lens wipes
Sterile wet wipes, Adult delay wipes, Sex delay wipes,Adults cleaning wipes
Screen clean wipes, Disinfection wipes, Isopropyl alcohol wipes
Swabs, Swab sticks (Povidone Iodine swabs, Alcohol swabs, Saline swabs), Cleaning Spray
Saline, Disinfectant (Saline Solution, Cleaning Solution); Saline, Pad (Saline pads, Saline wipes);
Sterile eye Sterile eye pad
Forceps, tweezers
Bar, stick, swab
Wound dressing, transparent wound dressing, dressing, chest seal
Alcohol pads, Alcohol swab, Alcohol prep pad, Alcohol wipes, Alcohol towel, Povidone iodine prep pad
Face mask,Disposable face mask
Wound closures, adhesive bandage, Israel wound dressing, tape
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device