FDA Registration
Active
🇨🇳 China
HUBEI WANLI PROTECTIVE PRODUCTS CO.,LTD
Reg #: 3008770063
·
FEI: 3008770063
·
Expires 2026
Products
15
Proprietary Names
29
Establishment Types
3
Classifications
15
Registration Details
- Registration Name
- HUBEI WANLI PROTECTIVE PRODUCTS CO.,LTD
- Registration Number
- 3008770063
- FEI Number
- 3008770063
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- NO.106 West Station Huangjin Road
- City
- xiantao Hubei
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K211509
Owner / Operator
- Firm Name
- Hubei Wanli Protective Products Co.,ltd
- Operator Number
- 10034851
- Address
- NO.106 West Station Huangjin Road
- City
- Xiantao
- State
- Hubei
- Postal Code
- 433000
- Country
- CN
- Correspondent
- Xiong Tang
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 |
|---|---|---|---|---|---|
| Stethoscope, Manual | LDE | Class 1 | Cardiovascular | No | 2017-01-16 |
| Sheet, Burn | FPY | Class 1 | General Hospital | No | 2011-09-16 |
| Cap, Surgical | FYF | Class 1 | General, Plastic Surgery | No | 2011-01-07 |
| Non-Surgical Gown | OEA | Class 1 | General, Plastic Surgery | No | 2011-01-07 |
| Tourniquet, Nonpneumatic | GAX | Class 1 | General, Plastic Surgery | No | 2017-01-16 |
| Bedding, Disposable, Medical | KME | Class 1 | General Hospital | No | 2011-01-07 |
| Gown, Surgical | FYA | Class 2 | General, Plastic Surgery | No | 2023-03-24 |
| 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 | 2020-11-20 |
| Respirator, Surgical | MSH | Class 2 | General, Plastic Surgery | No | 2021-12-29 |
| Mask, Surgical | FXX | Class 2 | General, Plastic Surgery | No | 2023-11-15 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2011-01-07 |
| Strap, Head, Gas Mask | BTK | Class 1 | Anesthesiology | No | 2014-05-12 |
| Sling, Arm | ILI | Class 1 | Physical Medicine | No | 2015-06-22 |
| Mask, Scavenging | KHA | Class 1 | Anesthesiology | No | 2011-01-07 |
| Cover, Shoe, Operating-Room | FXP | Class 1 | General, Plastic Surgery | No | 2011-01-07 |
Proprietary Names
Burn Sheet
CLIP CAP, BOUFFANT CAP, NON WOVEN CAP, PE CAP, DISPOSABLE CAP, NYLON CAP, Disposable Beard Cover
DISPOSABLE CAP
CLIP CAP
BOUFFANT CAP
NON WOVEN CAP
PE CAP
NYLON CAP
LAB COAT, DISPOSABLE non-SURGICAL GOWN, Disposable Pants, Disposable BP Cuff Sleeve Barrier, Lab Coat, SAUNA CLOTHES,
Patient exam gown, Disposable Suit
Stretcher sheets drape
NON WOVEN SHEETS, Equipment cover, Cot Sheet, CPE SHEETS, SMS SHEETS, DISPOSABLE BED SHEETS, PP+PE SHEETS,
Surgical Gown
Face Mask
KN95 PROTECTIVE MASK, TMKN95, CHKN95, WLM2013, WLM-2009
Disposable Medical Mask
Non woven coverall, Microporous coverall, PP+PE coverall, DISPOSABLE COVERALL, SMS coverall, Apron
Non woven coverall
PP+PE coverall
SMS coverall
DISPOSABLE COVERALL
Microporous coverall
Disposable Medical mask, Disposable medical mask (with bandage)
Triangular Bandage
DUST MASK
DISPOSBALE FACE MASK
PAPER MASK
DISPOSABLE SHOE COVER
DISPOSABLE SHOE COVER, Sleeve Cover
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)