Steris Sterilization Technologies (Suzhou) Ltd
Registered establishment in Suzhou, Jiangsu, China. 44 device types.
Steris Sterilization Technologies (Suzhou) Ltd is a contract manufacturer holding a current FDA establishment registration. The registration covers Trocar, Gown, Surgical and 42 other device types. Its earliest product listing with the FDA dates from 2012.
Registration
| Registered name | STERIS Sterilization Technologies (Suzhou) Ltd |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3008824097 |
| FEI number | 3008824097 |
| Establishment type | Contract manufacturer, Contract steriliser |
Chinese Registration
| Chinese legal name | 史帝瑞灭菌技术（苏州）有限公司 |
|---|---|
| Source | Baidu Baike |
Location
| City | Suzhou |
|---|---|
| Province | Jiangsu |
| Address | No26 Xinchang Road |
| Postal code | CP215125 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Alternate Controller Enabled Insulin Infusion Pump | Class 2 | Insulet5490 (SZ) – Omnipod 5 Automated Insulin Delivery System | 2024 | 2 |
| Brush, Scrub, Operating-Room | Class 1 | 2019 | 42 | |
| Cable, Electrode | Class 2 | 2019 | 47 | |
| Calculator, Drug Dose | Class 2 | Insulet5490 (SZ,VL2) – Omnipod DASH Insulin Management System, Insulet5490 (SZ) – OmniPod Insulin Management System | 2024 | 2 |
| Catheter And Tip, Suction | Class 2 | 2014 | 70 | |
| Catheter, Continuous Flush | Class 2 | Wallaby (SZ) – pNOVUS 17 | 2023 | 5 |
| Catheter, Electrode Recording, Or Probe, Electrode Recording | Class 2 | 2025 | 5 | |
| Catheter, Percutaneous | Class 2 | Wallaby (SZ) – Paragon Balloon Guide Catheter, Wallaby (SZ) – pNOVUS 17, Wallaby (SZ) – Pilote Long Sheath, Wallaby (SZ) – Esperance Distal Access Catheter System | 2023 | 14 |
| Catheter, Percutaneous, Neurovasculature | Class 2 | Wallaby (SZ) – Paragon Balloon Guide Catheter, Wallaby (SZ) – pNOVUS 17, Wallaby (SZ) – Pilote Long Sheath, Wallaby (SZ) – Esperance Distal Access Catheter System | 2023 | 6 |
| Catheter, Thrombus Retriever | Class 2 | Wallaby (SZ) – Esperance 3+ Aspiration Catheter System, Wallaby (SZ) – Esperance Aspiration Catheter System | 2023 | 5 |
| Catheter, Urethral | Class 2 | 2024 | 11 | |
| Catheter, Urological | Class 2 | 2019 | 9 | |
| Catheters, Suction, Tracheobronchial | Class 1 | 2014 | 93 | |
| Catheters, Transluminal Coronary Angioplasty, Percutaneous | Class 2 | 2025 | 12 | |
| Collector, Urine, (And Accessories) For Indwelling Catheter | Class 2 | 2019 | 51 | |
| Connector, Catheter | Class 1 | 2014 | 15 | |
| Device, Neurovascular Embolization | Class 2 | Wallaby (SZ) – Wallaby Avenir Coil System | 2023 | 5 |
| Drape, Surgical, Antimicrobial | Class 2 | 2013 | 39 | |
| Dressing, Wound, Occlusive | Class 1 | 2012 | 183 | |
| Electrosurgical, Cutting & Coagulation & Accessories | Class 2 | Covidien34498 (SZ) – Valleylab™ Suction Coagulator, Covidien34498 (SZ) – LigaSure™ Vessel Sealing System | 2024 | 65 |
| General Surgery Tray | Class 2 | 2013 | 24 | |
| Gown, Surgical | Class 2 | 2013 | 68 | |
| Guidewire, Catheter, Reprocessed | Class 2 | 2025 | 2 | |
| Interoperable Automated Glycemic Controller | Class 2 | Insulet5490 (SZ) – Omnipod 5 Automated Insulin Delivery System | 2024 | 1 |
| Introducer, Catheter | Class 2 | 2025 | 13 | |
| Kit, Surgical Instrument, Disposable | Class 1 | 2013 | 67 | |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Class 2 | 2025 | 15 | |
| Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | Class 2 | 2025 | 14 | |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive | Class 2 | 2025 | 8 | |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Class 2 | 2025 | 21 | |
| Protector, Skin Pressure | Class 1 | FirstWater14138 (RG) – F10LB/599/G2/2 Dr Scholl’s Corn Cushion – New Liner, FirstWater14138 (RG) – F12LB/648/C1/2 Dr Scholl’s Blister Cushion Dressing | 2019 | 101 |
| Pump, Infusion, Insulin | Class 2 | Insulet5490 (SZ) – Omnipod GO Insulin Delivery Device, Insulet5490 (SZ,VL2) – Omnipod DASH Insulin Management System, Insulet5490 (SZ) – OmniPod Insulin Management System | 2024 | 7 |
| Remover, Intrauterine Device, Contraceptive, Hook-Type | Class 1 | 2019 | 6 | |
| Screw, Fixation, Bone | Class 2 | 2025 | 31 | |
| Set, I.V. Fluid Transfer | Class 2 | 2019 | 8 | |
| Snare, Surgical | Class 1 | 2019 | 9 | |
| Surgical Smoke Precipitator | Class 2 | Alesi16551 (SZ) – Ultravision 5mm Trocar | 2023 | 1 |
| Syringe, Irrigating (Non Dental) | Class 1 | 2019 | 110 | |
| System, Irrigation, Urological | Class 2 | 2019 | 8 | |
| System, Test, Blood Glucose, Over The Counter | Class 2 | Insulet5490 (SZ,VL2) – Omnipod DASH Insulin Management System, Insulet5490 (SZ) – OmniPod Insulin Management System | 2024 | 20 |
| Tape And Bandage, Adhesive | Class 1 | Bedal12006 (ED,VL2) – Bedal Flex XS, Bedal Flex S, Bedal Flex M, Insulet5490 (SZ) – PodPals Adhesive Overlay | 2013 | 353 |
| Tracheobronchial Suction Catheter Kit | Class 1 | 2019 | 9 | |
| Trocar | Class 2 | 2025 | 9 | |
| Tube, Aspirating, Flexible, Connecting | Class 2 | 2019 | 51 |
From the Company
Published by the company on its own website, not by the FDA.
| Main products | Ethylene oxide sterilization, X-ray sterilization, Laboratory testing services |
|---|---|
| Export markets | APAC region |
| OEM and ODM | Offered |
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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