FDA Registration
Active
🇨🇳 China
ACTIS COLLARED HIGH SIZE 1
Reg #: 3004748528
·
FEI: 3004748528
·
Expires 2025
Products
4
Proprietary Names
27
Establishment Types
1
Classifications
4
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
- K202472
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/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2024-06-28 |
| Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | KWY | Class 2 | Orthopedic | No | 2024-06-28 |
| Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | MEH | Class 2 | Orthopedic | No | 2024-06-28 |
| Prosthesis, Hip, Hemi-, Femoral, Metal | KWL | Class 2 | Orthopedic | No | 2024-06-28 |
Proprietary Names
ACTIS COLLARED HIGH SIZE 1
ACTIS COLLARED STD SIZE 6
ACTIS COLLARED STD SIZE 9
ACTIS COLLARED STD SIZE 4
ACTIS COLLARED STD SIZE 3
ACTIS COLLARED HIGH SIZE 8
ACTIS COLLARED HIGH SIZE 7
ACTIS COLLARED HIGH SIZE 10
ACTIS COLLARED STD SIZE 8
ACTIS COLLARED HIGH SIZE 5
ACTIS COLLARED HIGH SIZE 4
ACTIS COLLARED HIGH SIZE 9
ACTIS COLLARED STD SIZE 7
ACTIS COLLARED STD SIZE 10
Actis DuoFix Hip Prosthesis
ACTIS COLLARED HIGH SIZE 12
ACTIS COLLARED STD SIZE 0
ACTIS COLLARED STD SIZE 12
ACTIS COLLARED STD SIZE 11
ACTIS COLLARED STD SIZE 5
ACTIS COLLARED HIGH SIZE 11
ACTIS COLLARED STD SIZE 2
ACTIS COLLARED STD SIZE 1
ACTIS COLLARED HIGH SIZE 3
ACTIS COLLARED HIGH SIZE 6
ACTIS COLLARED HIGH SIZE 2
ACTIS COLLARED HIGH SIZE 0
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)