FDA Registration
Active
🇨🇳 China
TPRLC 133 FP TYPE1 PPS SO 12
Reg #: 3004748528
·
FEI: 3004748528
·
Expires 2025
Products
8
Proprietary Names
53
Establishment Types
1
Classifications
8
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
- K200196
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, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | MEH | 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, Semi-Constrained, Metal/Polymer, Cemented | JDI | 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, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | KWY | 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, Uncemented | LZO | Class 2 | Orthopedic | No | 2022-06-30 |
| Prosthesis, Hip, Hemi-, Femoral, Metal | KWL | Class 2 | Orthopedic | No | 2022-06-30 |
Proprietary Names
TPRLC 133 FP TYPE1 PPS SO 12
TPRLC 133 FP TYPE1 PPS SO 18
TPRLC 133 FP TYPE1 PPS HO 20
TPRLC 133 T1 PPS HO 11X142MM
TPRLC 133 T1 PPS SO 17X154MM
TPRLC 133 FP TYPE1 PPS HO 15
TPRLC 133 T1 PPS SO 24X167MM
TPRLC 133 T1 PPS HO 24X167MM
TPRLC 133 FP TYPE1 PPS HO 24
TPRLC 133 FP TYPE1 PPS HO 16
TPRLC 133 FP TYPE1 PPS HO 8
TPRLC 133 TYPE1 PPS SO 9X137MM
TPRLC 133 FP TYPE1 PPS HO 13
TPRLC 133 FP TYPE1 PPS HO 22
TPRLC 133 FP TYPE1 PPS SO 14
TPRLC 133 FP TYPE1 PPS SO 17
TPRLC 133 T1 PPS HO 22X164MM
TPRLC 133 FP TYPE1 PPS SO 7
TPRLC 133 T1 PPS SO 10X140MM
TPRLC 133 T1 PPS SO 11X142MM
TPRLC 133 FP TYPE1 PPS HO 17
TPRLC 133 T1 PPS SO 16X152MM
TPRLC 133 T1 PPS SO 18X156MM
TPRLC 133 FP TYPE1 PPS HO 7
TPRLC 133 T1 PPS HO 16X152MM
TPRLC 133 FP TYPE1 PPS HO 12
TPRLC 133 FP TYPE1 PPS SO 22
TPRLC 133 T1 PPS HO 17X154MM
TPRLC 133 FP TYPE1 PPS SO 9
TPRLC 133 FP TYPE1 PPS SO 11
TPRLC 133 FP TYPE1 PPS HO 11
TPRLC 133 T1 PPS SO 14X148MM
TPRLC 133 T1 PPS SO 20X160MM
TPRLC 133 FP TYPE1 PPS HO 9
TPRLC 133 T1 PPS HO 13X146MM
TPRLC 133 T1 PPS HO 9X137MM
TPRLC 133 T1 PPS HO 12X144MM
TPRLC 133 FP TYPE1 PPS SO 10
TPRLC 133 FP TYPE1 PPS HO 14
TPRLC 133 FP TYPE1 PPS SO 16
TPRLC 133 FP TYPE1 PPS SO 24
TPRLC 133 FP TYPE1 PPS SO 8
TPRLC 133 T1 PPS SO 12X144MM
TPRLC 133 T1 PPS HO 15X150MM
TPRLC 133 T1 PPS HO 10X140MM
TPRLC 133 FP TYPE1 PPS SO 13
TPRLC 133 FP TYPE1 PPS SO 20
TPRLC 133 T1 PPS HO 14X148MM
TPRLC 133 T1 PPS HO 18X156MM
TPRLC 133 T1 PPS SO 22X164MM
TPRLC 133 T1 PPS HO 20X160MM
TPRLC 133 T1 PPS SO 15X150MM
TPRLC 133 FP TYPE1 PPS HO 10
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)