FDA Registration
Active
🇨🇳 China
Attune Dome Patella, ATTUNE MEDIAL DOME PAT 32MM
Reg #: 3004748528
·
FEI: 3004748528
·
Expires 2025
Products
1
Proprietary Names
6
Establishment Types
1
Classifications
1
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
- PMA Number
- P830055
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, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing | NJL | Class 3 | Unknown | No | 2019-04-15 |
Proprietary Names
Attune Dome Patella, ATTUNE MEDIAL DOME PAT 32MM
Attune Dome Patella, ATTUNE MEDIAL DOME PAT 35MM
Attune Dome Patella, ATTUNE MEDIAL DOME PAT 41MM
Attune Dome Patella, ATTUNE MEDIAL DOME PAT 38MM
Attune Dome Patella, ATTUNE MEDIAL DOME PAT 29MM
LCS(R) TOTAL KNEE SYSTEM
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)