FDA Registration
Active
🇹🇼 Taiwan
SYNTEC SCIENTIFIC CORP.
Reg #: 9616944
·
FEI: 3003414678
·
Expires 2025
Products
8
Proprietary Names
0
Establishment Types
1
Classifications
8
Registration Details
- Registration Name
- SYNTEC SCIENTIFIC CORP.
- Registration Number
- 9616944
- FEI Number
- 3003414678
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 2, KUNG SAN ROAD, CHUAN SHING, INDUSTRIAL ZONE, SHEN KANG
- City
- CHANG HUA Changhua
- Country
- TW
Regulatory Submissions
- 510(k) Number
- K110940
Owner / Operator
- Firm Name
- Syntec Scientific Corporation
- Operator Number
- 9034982
- Address
- No.2, Kung San Rd., Chuan Shing Industrial Zone, Shen Kang
- City
- Chang Hua Hsien
- State
- Changhua
- Postal Code
- 509
- Country
- TW
- Correspondent
- PETER CHANG
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Hip, Hemi-, Femoral, Metal | KWL | Class 2 | Orthopedic | No | 2023-01-06 |
| Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer | KWZ | Class 2 | Orthopedic | No | 2023-01-06 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2023-01-06 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | JDI | Class 2 | Orthopedic | No | 2023-01-06 |
| Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | KRO | Class 2 | Orthopedic | No | 2023-01-06 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | LWJ | Class 2 | Orthopedic | No | 2023-01-06 |
| Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | KWY | Class 2 | Orthopedic | No | 2023-01-06 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2023-01-06 |
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)