FDA Registration
Active
🇨🇳 China
STERIS Sterilization Technologies (Suzhou) Ltd
Reg #: 3008824097
·
FEI: 3008824097
·
Expires 2025
Products
3
Proprietary Names
0
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- STERIS Sterilization Technologies (Suzhou) Ltd
- Registration Number
- 3008824097
- FEI Number
- 3008824097
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- No26 Xinchang Road, Suzhou Industrial Park
- City
- Suzhou Jiangsu
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K173380
Owner / Operator
- Firm Name
- STERIS Corporation
- Operator Number
- 10042227
- Address
- 5960 Heisley Road
- City
- Mentor
- State
- OH
- Postal Code
- 44060
- Country
- US
US Agent
- Business Name
- Synergy Health
- Contact Name
- Becky Aldhizer
- Address
- 5960 Heisley Rd
- City
- Mentor
- State
- OH
- ZIP
- 44060
- Country
- US
- [email protected]
- Phone
- 440 3927490
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 | 2025-03-17 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2025-03-17 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2025-03-17 |
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)