FDA Registration
Active
🇨🇳 China
TPRLC 133 MP T1 PPS SO 8X101MM
Reg #: 3004748528
·
FEI: 3004748528
·
Expires 2025
Products
10
Proprietary Names
33
Establishment Types
1
Classifications
10
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
- K110400
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, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | KWY | Class 2 | Orthopedic | No | 2022-06-30 |
| Prosthesis, Hip, Hemi-, Femoral, Metal | KWL | 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 |
| 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 Uncemented Acetabular Component) | KWA | Class 3 | 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 Cemented Acetabular Component) | JDL | Class 3 | Orthopedic | No | 2022-06-30 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | JDI | Class 2 | Orthopedic | No | 2022-06-30 |
| Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented | OQG | Class 2 | Orthopedic | No | 2022-06-30 |
| Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer | KWZ | Class 2 | Orthopedic | No | 2022-06-30 |
Proprietary Names
TPRLC 133 MP T1 PPS SO 8X101MM
TPRLC 133 MP TYPE1 PPS SO 15
TPRLC 133 MP TYPE1 PPS HO 16
TPRLC 133 MP TYPE1 PPS SO 10
TPRLC 133 MP TYPE1 PPS SO 18
TPRLC 133 MP T1 PPS SO 7X99MM
TPRLC 133 MP TYPE1 PPS SO 11
TLOC 133 MP SP T1 PPS HO 5X95
TPRLC133 MP T1 PPS SO 6X97.5MM
TLOC 133 MP SP T1 PPS HO 6X97.5
TPRLC 133 MP TYPE1 PPS SO 9
TPRLC 133 MP TYPE1 PPS SO 12
TPRLC 133 MP TYPE1 PPS SO 16
TPRLC 133 MP TYPE1 PPS HO 15
TPRLC 133 MP TYPE1 PPS SO 17
TPRLC 133 MP TYPE1 PPS HO 11
TPRLC 133 MP TYPE1 PPS HO 20
TPRLC 133 MP TYPE1 PPS SO 24
TPRLC 133 MP TYPE1 PPS SO 13
TPRLC 133 MP TYPE1 PPS HO 12
TPRLC 133 MP TYPE1 PPS HO 24
TLOC 133 MP SP T1 PPS HO 7X99
TPRLC 133 MP TYPE1 PPS HO 9
TPRLC 133 MP TYPE1 PPS HO 18
TPRLC 133 MP TYPE1 PPS SO 20
TPRLC 133 MP T1 PPS SO 5X95MM
TPRLC 133 MP TYPE1 PPS HO 14
TLOC 133 MP SP T1 PPS HO 8X101
TPRLC 133 MP TYPE1 PPS SO 22
TPRLC 133 MP TYPE1 PPS HO 13
TPRLC 133 MP TYPE1 PPS HO 10
TPRLC 133 MP TYPE1 PPS HO 22
TPRLC 133 MP TYPE1 PPS SO 14
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)