FDA Registration
Active
🇭🇰 Hong Kong
Li Wai Precision International Limited
Reg #: 3009582259
·
FEI: 3009582259
·
Expires 2026
Products
27
Proprietary Names
0
Establishment Types
1
Classifications
27
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Registration Details
- Registration Name
- Li Wai Precision International Limited
- Registration Number
- 3009582259
- FEI Number
- 3009582259
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- RM 1804, 18/F, Cheuk Nang Centre, No. 9 Hillwood Road,
- City
- Tsimshatsui, Kowloon
- Country
- HK
Regulatory Submissions
- 510(k) Number
- K160895
Owner / Operator
- Firm Name
- Guangzhou Aquila Precise Tools Limited
- Operator Number
- 10044682
- Address
- RM 1804, Cheuk Nang Centre, 9 Hillwood Road
- City
- Tsim Sha Tsui, Kowloon
- State
- HK-NOTA
- Postal Code
- 00000
- Country
- HK
- Correspondent
- Angela Chan
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2017-02-13 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2014-08-07 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2016-06-24 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2017-03-02 |
| Extractor | HWB | Class 1 | Orthopedic | No | 2016-10-11 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2013-12-06 |
| Impactor | HWA | Class 1 | Orthopedic | No | 2016-04-08 |
| Tap, Bone | HWX | Class 1 | Orthopedic | No | 2017-08-22 |
| Instrument, Cutting, Orthopedic | HTZ | Class 1 | General, Plastic Surgery | No | 2023-02-17 |
| Helmet, Surgical | FXZ | Class 1 | General, Plastic Surgery | No | 2016-11-14 |
| Stripper, Surgical | HRT | Class 1 | Orthopedic | No | 2017-05-12 |
| Caliper | KTZ | Class 1 | Orthopedic | No | 2013-07-14 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2013-12-06 |
| Driver, Surgical, Pin | GFC | Class 1 | General, Plastic Surgery | No | 2013-07-14 |
| Bone Mill | LYS | Class 1 | Orthopedic | No | 2017-06-22 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2013-07-14 |
| Instruments Designed For Press-Fit Osteochondral Implants | QBO | Class 2 | Orthopedic | No | 2025-06-17 |
| Broach | HTQ | Class 1 | Orthopedic | No | 2015-01-30 |
| Driver, Prosthesis | HWR | Class 1 | Orthopedic | No | 2014-12-01 |
| Punch, Surgical | LRY | Class 1 | General, Plastic Surgery | No | 2017-06-01 |
| Rasp | HTR | Class 1 | General, Plastic Surgery | No | 2023-02-17 |
| Bit, Surgical | GFG | Class 1 | General, Plastic Surgery | No | 2014-12-01 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2013-11-29 |
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 2017-06-01 |
| Blade, Saw, General & Plastic Surgery, Surgical | GFA | Class 1 | General, Plastic Surgery | No | 2017-06-01 |
| Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | MBH | Class 2 | Orthopedic | No | 2013-11-29 |
| Template | HWT | Class 1 | Orthopedic | No | 2015-01-12 |
Establishment Types
Export Device to the United States But Perform No Other Operation on Device