STERIS TOMOE SINGAPORE PTE LTD

FDA Device Registration & Listing · Singapore South West, SG · Registration 3010421104

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3010421104
FEI Number
3010421104
Entity Name
STERIS TOMOE SINGAPORE PTE LTD
City/State/Country
Singapore South West, SG
Establishment Address
No. 47 Jalan Buroh, Unit # 01-01, Singapore South West 619491, SG
Establishment Type(s)
Sterilize Medical Device for Another Party (Contract Sterilizer)
Owner / Operator
Synergy Health AST, LLC (Owner Number: 10028672)
Owner / Operator Contact Address
5960 Heisley Road, Mentor, OH 44060, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

InnovexMed (SG) - Flexible Ureterorenoscope 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. InnovexMed (SG) - Flexible Ureterorenoscope InnovexMed (SG) - Flexible Ureterorenoscope

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FGB Ureteroscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2026-05-27
FGB Ureteroscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2026-05-27
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2025-11-20
KZE Injector, Fluid, Non-Electrically Powered General Hospital Class 2 880.5430 2025-11-20
FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days General Hospital Class 2 880.5200 2025-11-19
NEP System/Device, Pharmacy Compounding General Hospital Class 2 880.5440 2025-11-19
EOQ Bronchoscope (Flexible Or Rigid) Ear, Nose, Throat Class 2 874.4680 2026-05-27
DRS Transducer, Blood-Pressure, Extravascular Cardiovascular Class 2 870.2850 2025-11-20
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2025-11-19
FAJ Cystoscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2026-05-27
DRS Transducer, Blood-Pressure, Extravascular Cardiovascular Class 2 870.2850 2025-11-20
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2025-11-20
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2025-11-19
FPK Tubing, Fluid Delivery General Hospital Class 2 880.5440 2025-11-19
FTD Lamp, Surgical General, Plastic Surgery Class 2 878.4580 2025-11-20
FGO Dislodger, Stone, Flexible Gastroenterology, Urology Class 2 876.4680 2026-05-27
LWR Heart-Valve, Non-Allograft Tissue Unknown Class 3 N/A 2025-11-19
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2025-11-20
DSK Computer, Blood-Pressure Cardiovascular Class 2 870.1110 2025-11-20
FKX System, Peritoneal, Automatic Delivery Gastroenterology, Urology Class 2 876.5630 2025-11-20
FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days General Hospital Class 2 880.5200 2025-11-19
FGB Ureteroscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2026-05-27
FGB Ureteroscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2026-05-27
PTI Non-Coring (Huber) Needle General Hospital Class 2 880.5570 2025-12-12

Official Correspondent

No official correspondent registered.

US Agent Details

Becky Aldhizer Business: STERIS CORPORATION Email: becky_aldhizer@steris.com Phone: (440) 4687462

Related Public Records

Same Entity

Synergy Health AST, LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3009882464 Synergy Health AST, LLC Saxonburg, PA, US
3007738736 Synergy Health AST, SRL Alajuela, CR
3017636737 STERIS Corporation de Republica Dominicana, S.R.L. Santo Domingo, DO
2030598 Synergy Health AST, LLC SAN DIEGO, CA, US
3012102437 Synergy Health AST, LLC Petaluma, CA, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K915458 Psi Medical Products, Inc. URETEROSCOPE 1992-01-30
K100940 Andon Health Co, Ltd. FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5965 2010-06-29
K251581 Shenzhen Hingmed Medical Instrument Co., Ltd. Wearable Ambulatory Blood Pressure Monitor (WBP-02A) 2026-02-13
K200521 Health & Life Co., Ltd. Full Automatic(NIBP) Blood Pressure Monitor 2020-06-12
K152003 Andon Health Co, Ltd. iHealth BP3L Wireless Blood Pressure Monitor 2015-09-24

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0032-2025 MEDLINE INDUSTRIES, LP Northfield 2
MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001
Z-0033-2025 MEDLINE INDUSTRIES, LP Northfield 2
MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001U.
Z-0034-2025 MEDLINE INDUSTRIES, LP Northfield 2
MEDLINE Automatic Digital Blood Pressure Monitor, REF MDS1001UT.
Z-0002-2024 ARROW INTERNATIONAL Inc. 2
Arrow ErgoPack Complete, Pressure Injectable Arrowg+ard Blue Plus Four-Lumen CVC, REF CDC-42854- PCN1A; catheter, intravascular, therapeutic, long-term greater than 30 days
Z-0003-2024 ARROW INTERNATIONAL Inc. 2
Arrow Pressure Injectable Arrowg+ard Blue Plus Four-Lumen CVC, REF CDC-45854-P1A; catheter, intravascular, therapeutic, long-term greater than 30 days

Similar Registrations

Registration Number Establishment Name Location
3032429484 KARL STORZ Endovision, Inc. Franklin, MA, US
3010273872 Synergy Health AST, SRL Alajuela, CR
1000121056 Boston Scientific Corporation Coventry, RI, US
3013992977 OTU Medical Inc Union City, CA, US
3010202439 Karl Storz Endoscopy-America, Inc. El Segundo, CA, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010421104. Last updated year: 2026. Please use registration number 3010421104 when referencing this establishment in official correspondence.
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