FDA Registration
Active
🇨🇳 China
HUBEI KIMSOUL INDUSTRIAL CO.,LTD
Reg #: 3014198412
·
FEI: 3014198412
·
Expires 2026
Products
4
Proprietary Names
5
Establishment Types
7
Classifications
4
Registration Details
- Registration Name
- HUBEI KIMSOUL INDUSTRIAL CO.,LTD
- Registration Number
- 3014198412
- FEI Number
- 3014198412
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- NO.1 Guohezhen industrial zone
- City
- Xiantao Hubei
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K212398
Owner / Operator
- Firm Name
- HUBEI KIMSOUL INDUSTRIAL CO.,LTD
- Operator Number
- 10066643
- Address
- NO.1 Guohezhen industrial zone
- City
- Xiantao
- State
- Hubei
- Postal Code
- 433000
- Country
- CN
- Correspondent
- Faming zhang
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Mask, Surgical | FXX | Class 2 | General, Plastic Surgery | No | 2021-12-20 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2022-07-19 |
| Non-Surgical Gown | OEA | Class 1 | General, Plastic Surgery | No | 2020-04-02 |
| 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 | 2020-04-02 |
Proprietary Names
Surgical Face Mask (Non-sterile);Model:2020,2030
3D face mask
Coverall
isolation gown
Disposable face mask
Establishment Types
Manufacture Medical Device
Repack or Relabel Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Reprocess Single-Use Device
Remanufacture Medical Device
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device for Another Party (Contract Manufacturer)