FDA Registration
Active
🇨🇳 China
STERIS Sterilization Technologies (Suzhou) Ltd
Reg #: 3008824097
·
FEI: 3008824097
·
Expires 2026
Products
44
Proprietary Names
18
Establishment Types
1
Classifications
44
Registration Details
- Registration Name
- STERIS Sterilization Technologies (Suzhou) Ltd
- Registration Number
- 3008824097
- FEI Number
- 3008824097
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No26 Xinchang Road, Suzhou Industrial Park
- City
- Suzhou Jiangsu
- Country
- CN
Owner / Operator
- Firm Name
- STERIS Corporation
- Operator Number
- 10042227
- Address
- 5960 Heisley Road
- City
- Mentor
- State
- OH
- Postal Code
- 44060
- Country
- US
US Agent
- Business Name
- Synergy Health
- Contact Name
- Becky Aldhizer
- Address
- 5960 Heisley Rd
- City
- Mentor
- State
- OH
- ZIP
- 44060
- Country
- US
- [email protected]
- Phone
- 440 4687462
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Drape, Surgical, Antimicrobial | KKX | Class 2 | General, Plastic Surgery | No | 2013-01-21 |
| Gown, Surgical | FYA | Class 2 | General, Plastic Surgery | No | 2013-01-21 |
| Catheter, Urological | KOD | Class 2 | Gastroenterology, Urology | No | 2019-03-11 |
| Calculator, Drug Dose | NDC | Class 2 | Anesthesiology | No | 2024-09-10 |
| Pump, Infusion, Insulin | LZG | Class 2 | General Hospital | No | 2024-09-10 |
| System, Test, Blood Glucose, Over The Counter | NBW | Class 2 | Clinical Chemistry | No | 2024-09-10 |
| Catheter, Urethral | GBM | Class 2 | Gastroenterology, Urology | No | 2024-11-14 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2025-03-17 |
| System, Irrigation, Urological | LJH | Class 2 | Gastroenterology, Urology | No | 2019-03-11 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2024-09-20 |
| Connector, Catheter | GCD | Class 1 | General, Plastic Surgery | No | 2014-11-14 |
| General Surgery Tray | LRO | Class 2 | General, Plastic Surgery | No | 2013-01-21 |
| Kit, Surgical Instrument, Disposable | KDD | Class 1 | General, Plastic Surgery | No | 2013-03-19 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2013-01-16 |
| Catheter, Thrombus Retriever | NRY | Class 2 | Cardiovascular | No | 2025-09-19 |
| Catheters, Suction, Tracheobronchial | BSY | Class 1 | Anesthesiology | No | 2014-11-14 |
| Catheter, Electrode Recording, Or Probe, Electrode Recording | DRF | Class 2 | Cardiovascular | No | 2025-02-20 |
| Device, Neurovascular Embolization | HCG | Class 2 | Neurology | No | 2023-08-23 |
| Catheter, Percutaneous | DQY | Class 2 | Cardiovascular | No | 2023-08-23 |
| Catheter, Percutaneous, Neurovasculature | QJP | Class 2 | Cardiovascular | No | 2023-08-23 |
| Alternate Controller Enabled Insulin Infusion Pump | QFG | Class 2 | Clinical Chemistry | No | 2024-09-10 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive | OIY | Class 2 | Orthopedic | No | 2025-03-17 |
| Brush, Scrub, Operating-Room | GEC | Class 1 | General, Plastic Surgery | No | 2019-03-10 |
| Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | MEH | Class 2 | Orthopedic | No | 2025-03-17 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2025-03-17 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2025-03-17 |
| Dressing, Wound, Occlusive | NAD | Class 1 | General, Plastic Surgery | No | 2012-12-20 |
| Tube, Aspirating, Flexible, Connecting | BYY | Class 2 | General Hospital | No | 2019-03-10 |
| Syringe, Irrigating (Non Dental) | KYZ | Class 1 | General Hospital | No | 2019-03-11 |
| Protector, Skin Pressure | FMP | Class 1 | General Hospital | No | 2019-02-07 |
| Collector, Urine, (And Accessories) For Indwelling Catheter | KNX | Class 2 | Gastroenterology, Urology | No | 2019-03-11 |
| Surgical Smoke Precipitator | PQM | Class 2 | General, Plastic Surgery | No | 2023-02-28 |
| Catheters, Transluminal Coronary Angioplasty, Percutaneous | LOX | Class 2 | Cardiovascular | No | 2025-03-20 |
| Cable, Electrode | IKD | Class 2 | Physical Medicine | No | 2019-04-11 |
| Tracheobronchial Suction Catheter Kit | OFR | Class 1 | Anesthesiology | No | 2019-03-11 |
| Guidewire, Catheter, Reprocessed | NKQ | Class 2 | Cardiovascular | No | 2025-02-20 |
| Trocar | DRC | Class 2 | Cardiovascular | No | 2025-02-20 |
| Catheter And Tip, Suction | JOL | Class 2 | General Hospital | No | 2014-05-23 |
| Catheter, Continuous Flush | KRA | Class 2 | Cardiovascular | No | 2023-08-23 |
| Introducer, Catheter | DYB | Class 2 | Cardiovascular | No | 2025-02-20 |
| Interoperable Automated Glycemic Controller | QJI | Class 2 | Clinical Chemistry | No | 2024-09-10 |
| Set, I.V. Fluid Transfer | LHI | Class 2 | General Hospital | No | 2019-03-11 |
| Remover, Intrauterine Device, Contraceptive, Hook-Type | HHF | Class 1 | Obstetrics/Gynecology | No | 2019-03-10 |
| Snare, Surgical | GAE | Class 1 | General, Plastic Surgery | No | 2019-03-10 |
Proprietary Names
Insulet5490 (SZ,VL2) - Omnipod DASH Insulin Management System
Insulet5490 (SZ) - OmniPod Insulin Management System
Covidien34498 (SZ) - Valleylab Suction Coagulator
Insulet5490 (SZ) - PodPals Adhesive Overlay
Bedal12006 (ED,VL2) - Bedal Flex XS, Bedal Flex S, Bedal Flex M
Wallaby (SZ) - Esperance 3+ Aspiration Catheter System
Wallaby (SZ) - Esperance Aspiration Catheter System
Wallaby (SZ) - Wallaby Avenir Coil System
Wallaby (SZ) - Pilote Long Sheath
Insulet5490 (SZ) - Omnipod 5 Automated Insulin Delivery System
Insulet5490 (SZ) - Omnipod GO Insulin Delivery Device
FirstWater14138 (RG) - F12LB/648/C1/2 Dr Scholl's Blister Cushion Dressing
FirstWater14138 (RG) - F10LB/599/G2/2 Dr Scholls Corn Cushion - New Liner
Alesi16551 (SZ) - Ultravision 5mm Trocar
Covidien34498 (SZ) - LigaSure Vessel Sealing System
Wallaby (SZ) - Paragon Balloon Guide Catheter
Wallaby (SZ) - pNOVUS 17
Wallaby (SZ) - Esperance Distal Access Catheter System
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)