FDA Registration
Active
🇨🇳 China
Tablet Drape
Reg #: 3007007790
·
FEI: 3007007790
·
Expires 2025
Products
1
Proprietary Names
52
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 |
|---|---|---|---|---|---|
| Drape, Surgical, Exempt | PUI | Class 2 | General, Plastic Surgery | No | 2018-03-02 |
Proprietary Names
Tablet Drape
Corin Camera drape
CoreVista® Monitor Drape
1518/25
KL006/12
1648/25
KL701W/20
CFD024/20
19400/25
19405/50
KP11829/50
1538/25
KP11826/20
KL005W/20
OR004/20
1508/25
KL016W/10
1528W/10
KLF200/20
KL002/40
KP2226/20
KL004W/40
KL702W/20
SCCW01/20
KL005/20
KP1319F/50
KL001/80
KL703W/20
KL002W/40
KLF100/20
1265/25
KL001W/80
PFD019/50
1528/25
KP1826/25
Halyard Drape
1341/25
PHS 489150
KL030W/03
KL004/20
KL003/40
Robotic Arm Drape
0008
KL006/20
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Probe Covers
Drape and Calibration target for use with ActivSight imaging system
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)