FDA Registration
Active
🇸🇬 Singapore
STERIS TOMOE SINGAPORE PTE LTD
Reg #: 3010421104
·
FEI: 3010421104
·
Expires 2026
Products
27
Proprietary Names
9
Establishment Types
1
Classifications
27
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Registration Details
- Registration Name
- STERIS TOMOE SINGAPORE PTE LTD
- Registration Number
- 3010421104
- FEI Number
- 3010421104
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No. 47 Jalan Buroh, Unit # 01-01
- City
- Singapore South West
- Country
- SG
Owner / Operator
- Firm Name
- Synergy Health AST, LLC
- Operator Number
- 10028672
- Address
- 5960 Heisley Road
- City
- Mentor
- State
- OH
- Postal Code
- 44060
- Country
- US
US Agent
- Business Name
- STERIS CORPORATION
- Contact Name
- Becky Aldhizer
- Address
- 5960 Heisley Road
- City
- Mentor
- State
- OH
- ZIP
- 44060
- Country
- US
- [email protected]
- Phone
- 440 4687462
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Ureteroscope And Accessories, Flexible/Rigid | FGB | Class 2 | Gastroenterology, Urology | No | 2026-05-27 |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2025-11-20 |
| Injector, Fluid, Non-Electrically Powered | KZE | Class 2 | General Hospital | No | 2025-11-20 |
| Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | FOZ | Class 2 | General Hospital | No | 2025-11-19 |
| System/Device, Pharmacy Compounding | NEP | Class 2 | General Hospital | No | 2025-11-19 |
| Bronchoscope (Flexible Or Rigid) | EOQ | Class 2 | Ear, Nose, Throat | No | 2026-05-27 |
| Transducer, Blood-Pressure, Extravascular | DRS | Class 2 | Cardiovascular | No | 2025-11-20 |
| Catheter, Intravascular, Diagnostic | DQO | Class 2 | Cardiovascular | No | 2025-11-19 |
| Cystoscope And Accessories, Flexible/Rigid | FAJ | Class 2 | Gastroenterology, Urology | No | 2026-05-27 |
| Introducer, Catheter | DYB | Class 2 | Cardiovascular | No | 2025-11-20 |
| Catheter, Continuous Flush | KRA | Class 2 | Cardiovascular | No | 2025-11-19 |
| Tubing, Fluid Delivery | FPK | Class 2 | General Hospital | No | 2025-11-19 |
| Lamp, Surgical | FTD | Class 2 | General, Plastic Surgery | No | 2025-11-20 |
| Dislodger, Stone, Flexible | FGO | Class 2 | Gastroenterology, Urology | No | 2026-05-27 |
| Heart-Valve, Non-Allograft Tissue | LWR | Class 3 | Unknown | No | 2025-11-19 |
| Computer, Blood-Pressure | DSK | Class 2 | Cardiovascular | No | 2025-11-20 |
| System, Peritoneal, Automatic Delivery | FKX | Class 2 | Gastroenterology, Urology | No | 2025-11-20 |
| Non-Coring (Huber) Needle | PTI | Class 2 | General Hospital | No | 2025-12-12 |
| Catheter, Percutaneous | DQY | Class 2 | Cardiovascular | No | 2025-11-20 |
| Tubes, Vials, Systems, Serum Separators, Blood Collection | JKA | Class 2 | Clinical Chemistry | No | 2025-11-19 |
| Stopcock, I.V. Set | FMG | Class 2 | General Hospital | No | 2025-11-19 |
| Prosthesis, Mitral Valve, Percutaneously Delivered | NPU | Class 3 | Unknown | No | 2025-11-19 |
| Aortic Valve, Prosthesis, Percutaneously Delivered | NPT | Class 3 | Unknown | No | 2025-11-19 |
| Endoscopic Access Overtube, Gastroenterology-Urology | FED | Class 2 | Gastroenterology, Urology | No | 2026-05-27 |
| Actuator, Syringe, Injector Type | DQF | Class 2 | Cardiovascular | No | 2025-11-19 |
| Probe, Thermodilution | KRB | Class 2 | Cardiovascular | No | 2025-11-20 |
| Transducer, Pressure, Catheter Tip | DXO | Class 2 | Cardiovascular | No | 2025-11-20 |
Proprietary Names
InnovexMed (SG) - Flexible Ureterorenoscope
InnovexMed (SG) - Flexible Bronchoscope
InnovexMed (SG) - Flexible Cystoscope
InnovexMed (SG) - Urological Stone Extraction Baskets
EdwardsLifeSciences (SG) - MITRIS RESILIA Mitral Valve
EdwardsLifeSciences (SG) - INSPIRIS RESILIA Aortic Valve
Vantive (SG) - HOMECHOICE AUTOMATED PD SET W/CASS.-4 PRONG, EUR.
EdwardsLifeScience (SG) - Edwards SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve
InnovexMed (SG) - Ureteral Access Sheaths
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)