FDA Registration
Active
🇭🇰 Hong Kong
REGAL PROSTHESIS LIMITED
Reg #: 3004646509
·
FEI: 3004646509
·
Expires 2026
Products
5
Proprietary Names
1
Establishment Types
3
Classifications
5
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Registration Details
- Registration Name
- REGAL PROSTHESIS LIMITED
- Registration Number
- 3004646509
- FEI Number
- 3004646509
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Room 3D Mai Luen Industrial Building, 23-31 Kung Yip Street
- City
- Kwai Chung NT
- Country
- HK
Owner / Operator
- Firm Name
- REGAL PROSTHESIS LIMITED
- Operator Number
- 9083320
- Address
- Room 3D Mai Luen Industrial Building, 23-31 Kung Yip Street
- City
- Kwai Chung NT
- State
- HK-NOTA
- Postal Code
- -
- Country
- HK
US Agent
- Business Name
- Registrar Corp
- Contact Name
- David Lennarz
- Address
- 144 Research Drive
- City
- Hampton
- State
- VA
- ZIP
- 23666
- Country
- US
- [email protected]
- Phone
- 757 2240177
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Device, Prosthesis Alignment | IQO | Class 1 | Physical Medicine | No | 2016-08-30 |
| Material, External Aesthetic Restoration, No Adhesive | NOK | Class 1 | General, Plastic Surgery | No | 2020-07-29 |
| Joint, Hip, External Limb Component | ISL | Class 1 | Physical Medicine | No | 2016-08-30 |
| Joint, Knee, External Limb Component | ISY | Class 1 | Physical Medicine | No | 2016-08-30 |
| Component, External, Limb, Ankle/Foot | ISH | Class 1 | Physical Medicine | No | 2021-08-09 |
Proprietary Names
component, external, limb, ankle/foot
Establishment Types
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Repack or Relabel Medical Device