FDA Registration
Active
🇨🇳 China
M-408-10
Reg #: 3007007790
·
FEI: 3007007790
·
Expires 2025
Products
1
Proprietary Names
75
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Sterigenics Shanghai ETO Ltd.
- Registration Number
- 3007007790
- FEI Number
- 3007007790
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- No. 333, Shuang Hui Road, Yang Shan Free Port
- City
- Shanghai
- Country
- CN
Owner / Operator
- Firm Name
- Sotera Health LLC
- Operator Number
- 10029425
- Address
- 2015 Spring Road, Suite 650
- City
- Oak Brook
- State
- IL
- Postal Code
- 60523
- Country
- US
- Correspondent
- Karen Whaley-Krumins
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Protector, Skin Pressure | FMP | Class 1 | General Hospital | No | 2012-11-12 |
Proprietary Names
M-408-10
Protector, skin pressure
91101 SuperBump
8512/50
17590/20
2629
803-GP-10
907-GP-10
KNEEPAD/25
8541/50
8515/25
17408/20
17411/20
15516/24
17519/24
8544/100
SteriBump
7901W/25
17792/50
7908W/03
17410/50
8542/100
8527/50
7908W/25
17434/24
MEG012/20
8513/50
1745/25
8514/50
8525/50
1749/20
17412/20
17430/25
8533/100
7907W/03
17145/20
1746/20
8543/10
8555/20
PPPS01/10
8514/25
17413/20
PPPS08/10
17133/20
16120/24
7904W/10
8511/50
7903W/25
1741/50
8520/50
8511/20
14120/24
1742/25
17023/50
1742/10
17524/50
KNEEPLACER/10
FBP12/25
PPPS05/10
NSP001/10
7909W/03
8541/40
8523/50
1743/25
8522/50
7905W/20
17424/50
1744/25
8516/50
1747/20
508-E
803-GPE-10
Allevyn Life
907-GPE-10
CAST PADDING
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)