FDA Registration
Active
🇨🇳 China
TPRLC 133 FP TYPE1 PPS SO 6
Reg #: 3004748528
·
FEI: 3004748528
·
Expires 2025
Products
11
Proprietary Names
4
Establishment Types
1
Classifications
11
Registration Details
- Registration Name
- SHANGHAI JPY ION-TECH CO., LTD.
- Registration Number
- 3004748528
- FEI Number
- 3004748528
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- NO. 1168, HUIJIN ROAD, QINGPU INDUSTRIAL ZONE
- City
- SHANGHAI
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K103755
Owner / Operator
- Firm Name
- SHANGHAI JPY ION-TECH CO., LTD.
- Operator Number
- 9066119
- Address
- NO. 1168, HUIJIN ROAD, QINGPU INDUSTRIAL ZONE
- City
- SHANGHAI
- State
- CN-NOTA
- Postal Code
- 201707
- Country
- CN
US Agent
- Business Name
- MANTON BUSINESS & TECHNOLOGY SERVICES, LLC
- Contact Name
- Charles Shen
- Address
- 37 Winding Rdg
- City
- Oakland
- State
- NJ
- ZIP
- 07436
- Country
- US
- [email protected]
- Phone
- 608 2179358
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) | KWA | Class 3 | Orthopedic | No | 2022-06-30 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | JDI | Class 2 | Orthopedic | No | 2022-06-30 |
| Prosthesis, Hip, Hemi-, Femoral, Metal | KWL | Class 2 | Orthopedic | No | 2022-06-30 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | LWJ | Class 2 | Orthopedic | No | 2022-06-30 |
| Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | KWY | Class 2 | Orthopedic | No | 2022-06-30 |
| Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) | JDL | Class 3 | Orthopedic | No | 2022-06-30 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2022-06-30 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2022-06-30 |
| Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer | KWZ | Class 2 | Orthopedic | No | 2022-06-30 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish | MAY | Class 2 | Orthopedic | No | 2022-06-30 |
| Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | MEH | Class 2 | Orthopedic | No | 2022-06-30 |
Proprietary Names
TPRLC 133 FP TYPE1 PPS SO 6
TPRLC 133 FP TYPE1 PPS SO 5
TPRLC 133 FP TYPE1 PPS HO 6
TPRLC 133 FP TYPE1 PPS HO 5
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)