Sterigenics Shanghai E Beam Ltd.
Registered establishment in Shanghai, China. 14 device types.
Sterigenics Shanghai E Beam Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Pump, Infusion, Dressing, Wound, Occlusive and 12 other device types. Its earliest product listing with the FDA dates from 2010.
Registration
| Status | Registered |
|---|---|
| Registration expires | 2026 |
| Registration number | 3008132411 |
| FEI number | 3008132411 |
| Establishment type | Contract manufacturer, Contract steriliser |
Chinese Registration
| Chinese legal name | 上海辐新辐照技术有限公司 |
|---|---|
| Source | business registration directory |
Location
| City | Shanghai |
|---|---|
| Province | Shanghai |
| Address | A603 Lane 108, No. 588, Chuantu Road |
| Postal code | 201202 |
| Country | China |
Group
Sterigenics Shanghai E Beam Ltd. is one of 2 plants registered under Sotera Health LLC.
| Plant | City | Device types |
|---|---|---|
| Sterigenics Shanghai ETO Ltd. | Shanghai | 65 |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Agent, Absorbable Hemostatic, Non-Collagen Based | Class 3 | PerClot® Polysaccharide Hemostatic System | 2026 | 2 |
| Container, Specimen, Sterile | Class 1 | container, specimen, sterile Vacuette No -Additive Tubes, Clikseal, Portex Speciman Trap, Pathology Container, Snap Cap, PN 0501-1101, Pathology Container, Snap Cap, PN 0480-1111, Midstream Kit (Container Specimen) and 54 more | 2010 | 79 |
| Culture Media, Non-Propagating Transport | Class 1 | 2023 | 11 | |
| Device, Specimen Collection | Class 1 | 2023 | 3 | |
| Dressing, Wound, Hydrophilic | Class 1 | ConvaFoam Border, Foam/silicone Advazorb Silfix/Silfix Lite, Woven Eclypse, Super absorbent woven dressing Eclypse Boot, Aquacel Extra, Foam/silicone Advazorb/Advazorb Lite (Advazorb Plus) and 41 more | 2013 | 195 |
| Dressing, Wound, Occlusive | Class 1 | Episil, CUD+, Biatain Silicone Fit, 2″x3″ Reliamed Non-Adherent Dressing, Biatain, Foam Lite ConvaTec and 53 more | 2012 | 183 |
| Forceps, Biopsy, Non-Electric | Class 1 | 2017 | 44 | |
| Immunoglobulin G (Igg) Infusion System | Class 2 | 2025 | 2 | |
| Pump, Infusion | Class 2 | 2025 | 5 | |
| Set, Administration, Intravascular | Class 2 | 2025 | 49 | |
| Submucosal Injection Agent | Class 2 | 2023 | 3 | |
| System, Imaging, Pulsed Echo, Ultrasonic | Class 2 | ArcScan Insight 100, ED3 EyeSeal | 2020 | 37 |
| Tape And Bandage, Adhesive | Class 1 | CovRsite, KA1124/100, KA2154/50, TRU-FIX Catheter Fixation Kit, KA2254/25, KA1254/25 and 32 more | 2012 | 353 |
| Transducer, Ultrasonic, Diagnostic | Class 2 | ArcScan Insight 100, ED3 EyeSeal | 2020 | 44 |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2005 |
|---|---|
| Employees | 1600+ |
| Main products | Electron beam sterilization, Ethylene oxide sterilization, Gamma irradiation sterilization |
| Certifications | QMS certifications |
| Export markets | 47 locations in 13 countries |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
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