FDA Registration
Active
🇭🇰 Hong Kong
BLUE SAIL (HONG KONG) TRADING LIMITED
Reg #: 3009233038
·
FEI: 3009233038
·
Expires 2026
Products
13
Proprietary Names
6
Establishment Types
2
Classifications
13
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Registration Details
- Registration Name
- BLUE SAIL (HONG KONG) TRADING LIMITED
- Registration Number
- 3009233038
- FEI Number
- 3009233038
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Room 1401, 14/F, Wold Commerce Center,, 7-11 Canton Rd.,Tsim Sha Tsui
- City
- Harbour
- Country
- HK
Regulatory Submissions
- 510(k) Number
- K110314
Owner / Operator
- Firm Name
- BLUE SAIL (HONG KONG) TRADING LIMITED
- Operator Number
- 10039181
- Address
- Room 1401, 14/F, Wold Commerce Center,, 7-11 Canton Rd.,Tsim Sha Tsui
- City
- Harbour
- State
- HK-NOTA
- Postal Code
- 00000
- Country
- HK
- Correspondent
- Chuanzhi Sun
US Agent
- Business Name
- Omni International Corp
- Contact Name
- Renee Rees
- Address
- 35 Constitution Drive, Suite 1D
- City
- Bedford
- State
- NH
- ZIP
- 03110
- Country
- US
- [email protected]
- Phone
- 603 4711499 ext. 201
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Disinfectant, Medical Devices | LRJ | Class 1 | General Hospital | No | 2020-04-17 |
| Gown, Examination | FME | Class 1 | General Hospital | No | 2020-03-31 |
| Cover, Shoe, Operating-Room | FXP | Class 1 | General, Plastic Surgery | No | 2020-07-13 |
| Respirator, Surgical | MSH | Class 2 | General, Plastic Surgery | No | 2020-04-15 |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | HOY | Class 1 | Ophthalmic | No | 2020-03-31 |
| Vinyl Patient Examination Glove | LYZ | Class 1 | General Hospital | No | 2011-12-15 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2020-03-31 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2020-03-25 |
| Apron, Protective | IWO | Class 1 | Radiology | No | 2020-03-31 |
| Mask, Scavenging | KHA | Class 1 | Anesthesiology | No | 2020-03-31 |
| Shoe And Shoe Cover, Conductive | BWP | Class 1 | General, Plastic Surgery | No | 2020-07-13 |
| Non-Surgical Gown | OEA | Class 1 | General, Plastic Surgery | No | 2020-03-31 |
| Cap, Surgical | FYF | Class 1 | General, Plastic Surgery | No | 2020-07-13 |
Proprietary Names
N95 face mask
Disposable medical mask
KN95 face mask
Disposable protective mask
Face Shield, Safety Goggle, Spectacles
Mob Cap
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Export Device to the United States But Perform No Other Operation on Device