FDA Registration
Active
🇨🇳 China
HUBEI HUANFU PLASTIC PRODUCTS CO., LTD
Reg #: 3004105221
·
FEI: 3004105221
·
Expires 2026
Products
12
Proprietary Names
13
Establishment Types
2
Classifications
12
Registration Details
- Registration Name
- HUBEI HUANFU PLASTIC PRODUCTS CO., LTD
- Registration Number
- 3004105221
- FEI Number
- 3004105221
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No. 188 WANFU STREET, CHENHU TOWN
- City
- HANCHUAN CITY Hubei
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K212575
Owner / Operator
- Firm Name
- Hubei Huanfu Plastic Products Co., Ltd.
- Operator Number
- 9057645
- Address
- No. 188 Wanfu Street, Chenhu Town
- City
- Hanchuan
- State
- Hubei
- Postal Code
- 431608
- Country
- CN
- Correspondent
- Emily Chen
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 |
|---|---|---|---|---|---|
| Cap, Surgical | FYF | Class 1 | General, Plastic Surgery | No | 2003-07-28 |
| Non-Surgical Gown | OEA | Class 1 | General, Plastic Surgery | No | 2009-11-09 |
| Mask, Surgical | FXX | Class 2 | General, Plastic Surgery | No | 2021-12-24 |
| Bedding, Disposable, Medical | KME | Class 1 | General Hospital | No | 2012-05-10 |
| Suit, Surgical | FXO | Class 1 | General, Plastic Surgery | No | 2009-09-24 |
| Shoe And Shoe Cover, Conductive | BWP | Class 1 | General, Plastic Surgery | No | 2003-07-28 |
| Sheet, Burn | FPY | Class 1 | General Hospital | No | 2012-05-10 |
| Cover, Shoe, Operating-Room | FXP | Class 1 | General, Plastic Surgery | No | 2015-09-22 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2020-04-01 |
| 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 | 2020-04-28 |
| Gown, Examination | FME | Class 1 | General Hospital | No | 2003-07-28 |
| Shield, Protective, Personnel | KPY | Class 1 | Radiology | No | 2003-07-28 |
Proprietary Names
SURGICAL#GENERAL AND PLASTIC SURGE, RY, CAP
Coverall
Isolation Gown; gown; lab coat; lab jacket; Disposable Apron; Disposable PANT; Disposable COAT; scrub suit
Surgical Face Mask
blanket
Disposable Bedding
Expectant Father Kits
CONDUCTIVE#GENERAL AND PLASTIC SUR, SHOE COVER, GERY
Burn Sheet
Face Mask
GOWN
EXAMINATION#GENERAL HOSPITAL
PERSONNEL#RADIOLOGY
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)