FDA Registration
Active
🇨🇳 China
Splint, Abuction, Congenital Hip Dislocation
Reg #: 3034694939
·
FEI: 3034694939
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- ABLETECH ORTHOPEDICS CORPORATION
- Registration Number
- 3034694939
- FEI Number
- 3034694939
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 15F-3 No.1 Baosheng Rd., Yonghe Dist.
- City
- New Taipei City Taiwan
- Country
- CN
Owner / Operator
- Firm Name
- Abletech Orthopedics Corporation
- Operator Number
- 10092117
- Address
- 15F-3 No.1 Baosheng Rd., Yonghe Dist.
- City
- New Taipei City
- State
- Taiwan
- Postal Code
- 234635
- Country
- CN
- Correspondent
- Ramon Tseng
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 |
|---|---|---|---|---|---|
| Splint, Abduction, Congenital Hip Dislocation | IOZ | Class 1 | Physical Medicine | No | 2024-12-05 |
Proprietary Names
Splint, Abuction, Congenital Hip Dislocation
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device for Another Party (Contract Manufacturer)