Sterigenics Shanghai ETO Ltd.
Registered establishment in Shanghai, China. 65 device types.
Sterigenics Shanghai ETO Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Enema Kit, Bandage, Cast and 63 other device types. Its earliest product listing with the FDA dates from 2009.
Registration
| Status | Registered |
|---|---|
| Registration expires | 2026 |
| Registration number | 3007007790 |
| FEI number | 3007007790 |
| Establishment type | Contract manufacturer, Contract steriliser |
Location
| City | Shanghai |
|---|---|
| Province | Shanghai |
| Address | No. 333, Shuang Hui Road |
| Postal code | 201308 |
| Country | China |
Group
Sterigenics Shanghai ETO Ltd. is one of 2 plants registered under Sotera Health LLC.
| Plant | City | Device types |
|---|---|---|
| Sterigenics Shanghai E Beam Ltd. | Shanghai | 14 |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Accessories, Catheter | Class 1 | Valve Adapter, Argyle Penrose Tubing, SuperClip, “Prelude SNAP 165 Valved Splittable Sheath Introducer, Peritoneal Lavage drainage needle/catheter, Accessories, Catheter | 2012 | 33 |
| Accessory, Surgical Apparel | Class 1 | KP5020W/72, KP5030W/72, KP5015/50, ELM001, KP5070W/50, KP5019W/50 and 8 more | 2012 | 439 |
| Apparatus, Suction, Single Patient Use, Portable, Nonpowered | Class 1 | TRU-CLOSE Suction Drainage System, Suction Reservoir Kit, Jackson-Pratt Wound Drainage Devices | 2012 | 58 |
| Bag, Urine Collection, Leg, For External Use, Sterile | Class 1 | Extension Tubing, MEDICAL DEVICES INTERNATIONAL (MDI)- Drainage Bags, Drainage Bag, Medical Devices International, Conveen Security+, Conveen Contour | 2012 | 52 |
| Bandage, Cast | Class 1 | Cast, PLY, IAS, MED, TON, LEX and 1 more | 2012 | 81 |
| Bottle, Collection, Vacuum | Class 2 | BD Heimlich, Urological Sampler Sets, Thora-Vent Thoracic Vent, Surgical Filter | 2012 | 88 |
| Brush, Scrub, Operating-Room | Class 1 | 2013 | 42 | |
| Catheter And Tip, Suction | Class 2 | Repositional Chest Tube, Ortho, Argyle Surgical Aspirator Tip, Straight Connector: 33425, Safe-T-VAC: 31079, Safe-T-Vac Saline Tray: 12102 and 54 more | 2009 | 70 |
| Catheter Care Tray | Class 2 | 2017 | 12 | |
| Catheter, Irrigation | Class 1 | Reus Irrig Handpiece Clip, ST ULTRAPOWER BUR ACORN 6/MDS R-3 UltraPower, Safety Paracentesis Tray, Pericardiocentesis Catheter Kit Safety Paracentesis Tray, ReSolve Non-Locking Drainge Catheter, Total Abscession General Drainage Catheters and 16 more | 2012 | 24 |
| Catheter, Percutaneous | Class 2 | React 71 Catheter, React 68 Catheter, Navien Intracranial Support Catheter, Catheter, Percutaneous Reflex Intracranial Catheter | 2012 | 14 |
| Catheter, Percutaneous, Neurovasculature | Class 2 | 2024 | 6 | |
| Catheter, Straight | Class 2 | 2025 | 21 | |
| Catheter, Thrombus Retriever | Class 2 | Solitaire™ X | 2023 | 5 |
| Catheter, Urological | Class 2 | 2021 | 9 | |
| Catheters, Suction, Tracheobronchial | Class 1 | CAM Catheter; Complete Airway Management Catheter, CAM Rescue Cath, Argyle Specimen Traps, Argyle Lukens Specimen Container, Argyle Specimen Traps: 3583MST4000, Argyle Lukens Specimen Container: 8888258608, Argyle Specimen Traps: 8884724000 and 6 more | 2012 | 93 |
| Collector, Urine, (And Accessories) For Indwelling Catheter | Class 2 | Urinary drainage bag 2000cc anti reflux chamber, Drain bag holder vinyl, Drainage BAG, BAG, Urinary Drain, Vinyl LF Anit-Reflux Chamber/Flutter Valve 2000 ML, Urinary drainage Bag Holder, Urinary drainage bag 2000cc and 54 more | 2013 | 51 |
| Connector, Catheter | Class 1 | DMEK instruments and pack, Connect Tube: 8888270603, Connect Tube: 8888270207 | 2016 | 15 |
| Container, Specimen, Non-Sterile | Class 1 | Centrifuge Tubes, Transport Vial, Speciman Container | 2012 | 115 |
| 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 |
| Continuous Measurement Thermometer | Class 2 | Myocardial Needle Probe Esophogeal Stethoscope, Bio-Probe Flow Probe Disposable Insert, TYMPANIC TEMPERATURE SENSOR – Starboard, SKIN TEMPERATURE SENSOR – Starboard | 2012 | 115 |
| Cover, Barrier, Protective | Class 2 | 2017 | 15 | |
| Device, Paste-On For Incontinence, Sterile | Class 1 | Urine collector pediatric st | 2016 | 12 |
| Device, Urine Flow Rate Measuring, Non-Electrical, Disposable | Class 2 | Urinemeters | 2013 | 19 |
| Dislodger, Stone, Flexible | Class 2 | Urological Stone Extraction Baskets | 2026 | 2 |
| Drape, Surgical, Antimicrobial | Class 2 | Arrow Select Kits, Eclipse, Aurora, Sirus, Prevention Plus, OR Towel, Drapes, Column Drape, KP11827/250, IF1000 Vision Probe Bag – 490127 and 4 more | 2013 | 39 |
| Drape, Surgical, Exempt | Class 2 | Tablet Drape, Halyard Basics Drape, 1528/25, KP1319F/50, 1518/25, KL006/12 and 47 more | 2018 | 107 |
| Dressing, Wound, Drug | Class U | ALLEVYN Ag Dressings (includes Ag Gentle Border) | 2012 | 48 |
| 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 |
| Electrosurgical, Cutting & Coagulation & Accessories | Class 2 | LF3225 LigaSureTM Curved Jaw, Open Sealer/Divider Electrode, LigaSure™ V 5 mm sealer/divider (LS1500 & LS1520), LigaSure Handswitching Atlas (LS1020 & LS1037), Vessel Sealing LigaSure Handswitching Atlas (LS1020 & LS1037, Grasping, blunt dissection and dividing tissue LigaSure™ V 5 mm sealer/divider (LS1500 & LS1520), Vessel Sealer/Divider LF1212A LigasureTM Curved, Small Jaw, Open Sealer/Divider and 12 more | 2012 | 65 |
| Endoscopic Access Overtube, Gastroenterology-Urology | Class 2 | Hoover Negative Pressure Access Sheath | 2026 | 19 |
| Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt | Class 2 | Single Use Grasping Forceps | 2026 | 21 |
| Enema Kit | Class 1 | Enema Catheter | 2013 | 24 |
| Fiber, Medical, Absorbent | Class 1 | Fiber, Medical, Absorbant, Medical Cotton Ball, 8430/06, 3034W/24, 3234/24, 8106/50 and 54 more | 2012 | 172 |
| Gauze / Sponge,Nonresorbable For External Use | Class 1 | XGAUZE Trauma Pad, Venture Brand, Richmond Dental & Medical, Compressed Gauze, 7806/24, 7706/50 and 54 more | 2012 | 266 |
| Gauze/Sponge, Internal, X-Ray Detectable | Class 1 | Nonabsorbable gauze for internal use, x-ray detectable, Gauze/Sponge, Internal, X-RAY Detectable, Laparotomy Sponges | 2012 | 67 |
| General Surgery Tray | Class 2 | Medline / Proxima / Aurora / Sirus / UltraGard / OrthoMax | 2016 | 24 |
| Gown, Surgical | Class 2 | Arrow Select Kits, Eclipse, Aurora, Sirus, Prevention Plus, Eclipse, Aurora, Sirus, Prevention Plus | 2013 | 68 |
| Injector And Syringe, Angiographic | Class 2 | Avanta Hand Controller (AVA 500 HC), AVA-500-MPAT (Part 2 of 2) Avanta Multi Patient Tube Set, Avanta Multi-Patient Disposable Set, Avanta Hand-Controller, Avanta Single-Patient Disposable Set, SET, Packaged, MEDRAD Avanta, Syringe, RAD Stable AVA 500 SYR and 13 more | 2016 | 15 |
| Instrument, Manual, Surgical, General Use | Class 1 | Trocar Cleaner – XL 12 mm, DS Portal Tube Package ASM, No. 550-0013, Portal Tube Package ASM, No. 315-0016, Guide Pin 2.4 x 508 T/R Package ASM, No. 300-1010, Guide Pin 1.1 x 635 Package ASM, No. 430-0041, Guide Pin 2.4 x 508 R/R Package ASM, No. 300-1011 and 37 more | 2012 | 110 |
| Irrigator, Sinus | Class 1 | HydroCleanse™ Sinus Wash Delivery System | 2025 | 27 |
| Kit, Surgical Instrument, Disposable | Class 1 | Sponges Gauze NON Sterile Bulk 3X3 12 PLY, Towels Cotton NON Sterile Bulk, Sponges Gauze NON Sterile Bulk 4X4 16PLY Gauze Washed Bolt NON Sterile Bulk, Sponges Gauze NON Sterile Bulk 4X4 8 PLY, Surgical Instrument Kit Disposable, Stockinette Cotton and 54 more | 2009 | 67 |
| Needle, Aspiration And Injection, Disposable | Class 1 | SureAx-HOOK, Cardinal blunt fill needle wwithout filter, Cardinal blunt fill needle with filter, OnPharma OnSet Cartridge Connector, Homer Breast Localization Needles, MiniStop Plus and 27 more | 2012 | 37 |
| Needle, Hypodermic, Single Lumen | Class 2 | Cardinal luer lock syringe with safety needle | 2016 | 71 |
| Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment | Class 2 | Solitaire™ X | 2023 | 2 |
| Protector, Skin Pressure | Class 1 | ALLEVYN Complete Care, 824-P, Protector, skin pressure, 803-GP-10, 14120/24, 1742/10 and 54 more | 2012 | 101 |
| Pump, Air, Non-Manual, For Endoscope | Class 2 | 2026 | 4 | |
| Pump, Infusion, Insulin | Class 2 | V-Go Insulin Delivery System, V-Go Disposable Insulin Delivery System | 2013 | 7 |
| Set, Administration, Intravascular | Class 2 | V-Go Insulin Delivery System, V-Go Disposable Insulin Delivery System | 2013 | 49 |
| Skin Prep Tray | Class 1 | Skin Prep tray w/20oz. Paint, Skin prep tray w/4 oz. Scrub & 4 oz. Paint, Prep skin tray, Skin Prep Tray Wet CHG 4% w/Glove, Skin Prep Tray Wet CHG 4% w/Sponges, Skin Prep Tray Wet PVP-I w/Glove and 2 more | 2013 | 8 |
| Staple, Implantable | Class 2 | Preminu Plus Curved End to End Anastomosis–PPCEEA (111983/111985/111987/111989/111981), Single Use StaplersCEEA (CEEA25/28/31/34) | 2012 | 16 |
| Stethoscope, Esophageal, With Electrical Conductors | Class 2 | Esophageal Rectal Probe With Temperature Sensor, Starboard – Esophageal Stethoscope With Temperature Sensor | 2012 | 3 |
| Stocking, Medical Support (For General Medical Purposes) | Class 1 | Stocking, Medical Support | 2016 | 76 |
| Syringe, Antistick | Class 2 | Cardinal luer lock syringe with safety needle, sol-millennium sol-care | 2016 | 39 |
| Syringe, Irrigating (Non Dental) | Class 1 | Irrigating Syringe, Enteral irrigation syringe 60cc NS, Piston enteral irrigation syringe 60cc NS, Flat top piston irrigation syringe 60cc ST, Thumb control piston irrigation syringe 60cc ST, Igloo Wound Irrigation System and 8 more | 2012 | 110 |
| Syringe, Piston | Class 2 | Cardinal luer lock syringe with safety needle | 2021 | 60 |
| System, Ablation, Microwave And Accessories | Class 2 | Emprint™ Reinforced Short Percutaneous Antenna with Thermosphere™ Technology, CA15L2, Emprint™ Reinforced Long Percutaneous Antenna with Thermosphere™ Technology, CA30L2, Emprint™ Reinforced Standard Percutaneous Antenna with Thermosphere™ Technology, CA20L2, Emprint™ Standard Percutaneous Antenna with Thermosphere™ Technology, CA20L1/CA20L2, Emprint™ Long Percutaneous Antenna with Thermosphere™ Technology, CA30L1/CA30L2, Emprint™ Short Percutaneous Antenna with Thermosphere™ Technology, CA15L1/CA15L2 and 3 more | 2014 | 10 |
| System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile | Class 1 | Night Drainage Collector | 2012 | 23 |
| 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 |
| Tracheobronchial Suction Catheter Kit | Class 1 | 2018 | 9 | |
| Tube, Aspirating, Flexible, Connecting | Class 2 | Suction conneting tube, Aspiration Tubing | 2012 | 51 |
| Tubing, Fluid Delivery | Class 2 | MEDRAD Twist & Go High Pressure Connector Tubing, Twist & Go HPCT, 20”, Twist & Go, HPCT, 48”, TAG C75 HPCT Twist-and-Go High Pressure Connector Tube 75 cm, Twist & Go Disposable Syringe Kit, Twist & Go, HPCT, 60” and 11 more | 2016 | 2 |
| Tubing, Noninvasive | Class 2 | Zinnanti Smoke Evacuation Tubing Kit, 19652/20, 19644/20, 19645/25, 19631/20, 19713/50 and 54 more | 2012 | 33 |
| Unit, Phacofragmentation | Class 2 | VERITAS™ Phacoemulsification Console, VERITAS™ Advanced Fluidics Pack and Advanced Infusion Pack, Dual Pump Pack | 2023 | 4 |
| Urinary Drainage Collection Kit, For Indwelling Catheter | Class 2 | MEDICAL DEVICES INTERNATIONAL (MDI)- Drainage Bags, Urinary drainage collection kit, for indwelling catheter, P400 Premium Urine Meter: P4PAD, ULTRAMER Foley Tray Latex Cath: 6165LL, P400 Premium Urine Meter: P4P14SD, P400 Premium Urine Meter: P4P18ULP and 37 more | 2013 | 11 |
From the Company
Published by the company on its own website, not by the FDA.
| Main products | ETO sterilization services, Electron beam processing |
|---|
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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