STERIS Corporation de Republica Dominicana, S.R.L.

FDA Device Registration & Listing · Santo Domingo, DO · Registration 3017636737

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
3017636737
FEI Number
3017636737
Entity Name
STERIS Corporation de Republica Dominicana, S.R.L.
City/State/Country
Santo Domingo, DO
Establishment Address
Zona Franca Las Americas KM. 22 Autopista las Americas Santo Domingo Este, Calle 15 esq. Calle 10, Santo Domingo 00000, DO
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

Richline (DR)-Inverness Ear Piercing Instruments; Inverness Ear-Nose Piercing Instrument; Inverness Ear Piercing Earring Biomerics6631 (SDB) - Disposable Knot Pusher DAS MEDICAL (DR) - Intuitive (ISI) DAS MEDICAL (DR) - Medtronic DAS MEDICAL (DR) - One Degree Medical DAS MEDICAL (DR) - Moon Surgical DAS MEDICAL (DR) - Bio Vision DAS MEDICAL (DR) - DAS DAS MEDICAL (DR) - Arbutus DAS MEDICAL (DR) - Grace Medical DAS MEDICAL (DR) - Surgical Table DAS MEDICAL (DR) - Asensus DAS MEDICAL (DR) - Active Life Scientific DAS MEDICAL (DR) - Das Medical DAS MEDICAL (DR) - WEG DAS MEDICAL (DR) - Procept DAS MEDICAL (DR) - Obvius Robotics DAS MEDICAL (DR) - Coulmed DAS MEDICAL (DR) - Rampart DAS MEDICAL (DR) - Image Diagnostics Inc (IDI) DAS MEDICAL (DR) - Auris Health DAS MEDICAL (DR) - Stryker DAS MEDICAL (DR) - Medical Micro Instrument (MMI) DAS MEDICAL (DR) - Raico DAS MEDICAL (DR) - PROteger / Clear surgical Solutions DAS MEDICAL (DR) - nView DAS MEDICAL (DR) - Magic Leap DAS MEDICAL (DR) - Monogram DAS MEDICAL (DR) - Atec DAS MEDICAL (DR) - Forsight Robotics DAS MEDICAL (DR) - Sterimed DAS MEDICAL (DR) - Image Diagnostics Inc (IDI) DAS MEDICAL (DR) - Procept DAS MEDICAL (DR) - Mendaera

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DSA Cable, Transducer And Electrode, Patient, (Including Connector) Cardiovascular Class 2 870.2900 2026-01-22
JYS Perforator, Ear-Lobe Ear, Nose, Throat Class 1 874.4420 2026-04-28
FRN Pump, Infusion General Hospital Class 2 880.5725 2025-11-24
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2025-11-26
FMG Stopcock, I.V. Set General Hospital Class 2 880.5440 2025-11-24
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2025-11-26
FTA Light, Surgical, Accessories General, Plastic Surgery Class 2 878.4580 2025-11-25
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2025-11-26
QJP Catheter, Percutaneous, Neurovasculature Cardiovascular Class 2 870.1250 2025-11-26
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2025-11-26
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2025-11-26
LKG Port & Catheter, Implanted, Subcutaneous, Intraventricular Neurology Class 2 882.5550 2025-11-26
KMK Device, Intravascular Catheter Securement General Hospital Class 1 880.5210 2025-11-25
ETA Replacement, Ossicular Prosthesis, Total Ear, Nose, Throat Class 2 874.3495 2025-11-25
FZP Clip, Implantable General, Plastic Surgery Class 2 878.4300 2025-11-26
GDO Applier, Surgical, Clip General, Plastic Surgery Class 1 878.4800 2025-11-26
LFL Instrument, Ultrasonic Surgical Unknown Class U N/A 2025-11-25
FMG Stopcock, I.V. Set General Hospital Class 2 880.5440 2025-11-24
FJK Set, Tubing, Blood, With And Without Anti-Regurgitation Valve Gastroenterology, Urology Class 2 876.5820 2025-11-24
KOC Accessories, Blood Circuit, Hemodialysis Gastroenterology, Urology Class 2 876.5820 2025-11-24
FRN Pump, Infusion General Hospital Class 2 880.5725 2025-11-24
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2025-11-24
FRN Pump, Infusion General Hospital Class 2 880.5725 2025-11-24
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2025-11-24
JCY Catheter, Infusion General, Plastic Surgery Class 1 878.4200 2025-11-25
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2025-11-26
LBN Replacement, Total Ossicular, Prosthesis, Porous, Polyethylene Ear, Nose, Throat Class 2 874.3495 2025-11-25
LCJ Tissue Expander And Accessories Unknown Class U N/A 2025-11-25
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2025-11-24
KYX Dispenser, Liquid Medication General Hospital Class 1 880.6430 2025-11-25
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2025-11-26
GWF Stimulator, Electrical, Evoked Response Neurology Class 2 882.1870 2025-11-25
ETN Stimulator, Nerve Ear, Nose, Throat Class 2 874.1820 2025-11-25
KGY Bag, Intestine General, Plastic Surgery Class 1 878.4100 2025-11-25
LHI Set, I.V. Fluid Transfer General Hospital Class 2 880.5440 2026-01-22
LHI Set, I.V. Fluid Transfer General Hospital Class 2 880.5440 2025-11-25
FRN Pump, Infusion General Hospital Class 2 880.5725 2025-11-24
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2025-11-26
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2025-11-26
KYB Lens, Guide, Intraocular Ophthalmic Class 1 886.4300 2025-11-24
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2025-11-26
ETB Prosthesis, Partial Ossicular Replacement Ear, Nose, Throat Class 2 874.3450 2025-11-25
FMH Container, Specimen, Sterile Pathology Class 1 864.3250 2025-11-25
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2025-11-26
ETN Stimulator, Nerve Ear, Nose, Throat Class 2 874.1820 2025-11-25
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2025-11-24
IKN Electromyograph, Diagnostic Physical Medicine Class 2 890.1375 2025-11-25
BYY Tube, Aspirating, Flexible, Connecting General Hospital Class 2 880.6740 2019-01-14
KNW Instrument, Biopsy Gastroenterology, Urology Class 2 876.1075 2026-01-22
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2025-11-26
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2025-11-24
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2025-11-24
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2025-11-26
FNP Urinal General Hospital Class 1 880.6730 2025-11-25
DXO Transducer, Pressure, Catheter Tip Cardiovascular Class 2 870.2870 2022-01-04
FYA Gown, Surgical General, Plastic Surgery Class 2 878.4040 2026-04-24
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2025-11-26
ETA Replacement, Ossicular Prosthesis, Total Ear, Nose, Throat Class 2 874.3495 2025-11-25
QJP Catheter, Percutaneous, Neurovasculature Cardiovascular Class 2 870.1250 2025-11-26
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2025-11-26
ETD Tube, Tympanostomy Ear, Nose, Throat Class 2 874.3880 2025-11-25
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2025-11-26
ETB Prosthesis, Partial Ossicular Replacement Ear, Nose, Throat Class 2 874.3450 2025-11-25
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2025-11-24
LFB Button, Nasal Septal Unknown Class U N/A 2025-11-25
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2025-11-26
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2025-11-24
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2025-11-24
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2025-11-26
DXO Transducer, Pressure, Catheter Tip Cardiovascular Class 2 870.2870 2025-11-25
ETB Prosthesis, Partial Ossicular Replacement Ear, Nose, Throat Class 2 874.3450 2025-11-25
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2025-11-26
FMG Stopcock, I.V. Set General Hospital Class 2 880.5440 2025-11-24
FMF Syringe, Piston General Hospital Class 2 880.5860 2025-11-24
MFK Lens, Multifocal Intraocular Ophthalmic Class 3 886.3600 2025-11-21
ETD Tube, Tympanostomy Ear, Nose, Throat Class 2 874.3880 2025-11-25
LHI Set, I.V. Fluid Transfer General Hospital Class 2 880.5440 2025-11-25
KGZ Accessories, Catheter General, Plastic Surgery Class 1 878.4200 2025-11-25
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2025-11-26
DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass Cardiovascular Class 2 870.4290 2025-11-24
LYA Splint, Intranasal Septal Ear, Nose, Throat Class 1 874.4780 2025-11-25
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2025-11-25
EXF Bag, Bile Collecting Gastroenterology, Urology Class 2 876.5010 2026-01-22
GXZ Electrode, Needle Neurology Class 2 882.1350 2025-11-25
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2025-11-26
NAY System, Surgical, Computer Controlled Instrument Gastroenterology, Urology Class 2 876.1500 2025-11-25
GAA Needle, Aspiration And Injection, Disposable General, Plastic Surgery Class 1 878.4800 2025-11-25
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2025-11-24
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2025-11-24
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2025-11-24
FZP Clip, Implantable General, Plastic Surgery Class 2 878.4300 2025-11-26
GDO Applier, Surgical, Clip General, Plastic Surgery Class 1 878.4800 2025-11-26
LKG Port & Catheter, Implanted, Subcutaneous, Intraventricular Neurology Class 2 882.5550 2025-11-26
DWS Instruments, Surgical, Cardiovascular Cardiovascular Class 1 870.4500 2012-11-16
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2025-11-24
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2025-11-26
GDH Gouge, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2025-11-26
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2025-11-24
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2025-11-26
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2025-11-26
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2025-11-26
PUI Drape, Surgical, Exempt General, Plastic Surgery Class 2 878.4370 2025-11-25
ETB Prosthesis, Partial Ossicular Replacement Ear, Nose, Throat Class 2 874.3450 2025-11-25
MIJ Needle, Tumor Localization General, Plastic Surgery Class 1 878.4800 2015-10-26
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2025-11-24
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2025-11-24
FRN Pump, Infusion General Hospital Class 2 880.5725 2025-11-24
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2025-11-24
ETD Tube, Tympanostomy Ear, Nose, Throat Class 2 874.3880 2025-11-25
SCV Modular Electromechanical Surgical System General, Plastic Surgery Class 2 878.4964 2025-12-10
ETD Tube, Tympanostomy Ear, Nose, Throat Class 2 874.3880 2025-11-25
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2025-11-24
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2025-11-24
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2025-11-26
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2025-11-26
GWM Device, Monitoring, Intracranial Pressure Neurology Class 2 882.1620 2025-11-26
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2025-11-24
MMZ Table, Cystometric, Electric Gastroenterology, Urology Class 2 876.4890 2026-03-30
FMF Syringe, Piston General Hospital Class 2 880.5860 2025-11-24
LRO General Surgery Tray General, Plastic Surgery Class 2 878.4370 2026-04-24
LKG Port & Catheter, Implanted, Subcutaneous, Intraventricular Neurology Class 2 882.5550 2025-11-26
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2025-11-26
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2025-11-26
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2025-11-24
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2025-11-26
ETA Replacement, Ossicular Prosthesis, Total Ear, Nose, Throat Class 2 874.3495 2025-11-25
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2025-11-24
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2025-11-24
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2025-11-26
LYU Accessory, Surgical Apparel General, Plastic Surgery Class 1 878.4040 2026-04-24
FYA Gown, Surgical General, Plastic Surgery Class 2 878.4040 2026-04-24
EOB Nasopharyngoscope (Flexible Or Rigid) Ear, Nose, Throat Class 2 874.4760 2025-11-25
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2025-11-24
FMF Syringe, Piston General Hospital Class 2 880.5860 2025-11-24
LBM Porous Polyethylene Ossicular Replacement Ear, Nose, Throat Class 2 874.3450 2025-11-25
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2025-11-26
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2025-11-25
HQL Intraocular Lens Ophthalmic Class 3 886.3600 2025-11-24
MAJ Catheter, Percutaneous, Intraspinal, Short Term Anesthesiology Class 2 868.5120 2025-11-26
LBM Porous Polyethylene Ossicular Replacement Ear, Nose, Throat Class 2 874.3450 2025-11-25
EYY Drape, Urological, Disposable General, Plastic Surgery Class 2 878.4370 2025-11-25
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2025-11-26
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2025-11-26
LHI Set, I.V. Fluid Transfer General Hospital Class 2 880.5440 2025-11-25
DRS Transducer, Blood-Pressure, Extravascular Cardiovascular Class 2 870.2850 2025-11-24
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2025-11-26
GDW Staple, Implantable General, Plastic Surgery Class 2 878.4750 2025-11-26
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2025-11-26
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2025-11-26
LJH System, Irrigation, Urological Gastroenterology, Urology Class 2 876.5130 2025-11-25
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2025-11-26
OCT Anti Fog Solution And Accessories, Endoscopy Gastroenterology, Urology Class 2 876.1500 2026-01-08
OCW Endoscopic Tissue Approximation Device Gastroenterology, Urology Class 2 876.1500 2025-11-26
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2025-11-24
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2025-11-26
ETN Stimulator, Nerve Ear, Nose, Throat Class 2 874.1820 2025-11-25
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2025-11-24
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2025-11-24
LHI Set, I.V. Fluid Transfer General Hospital Class 2 880.5440 2025-11-25
HMT Drape, Patient, Ophthalmic General, Plastic Surgery Class 2 878.4370 2026-04-24
GDT Staple, Removable (Skin) General, Plastic Surgery Class 1 878.4760 2025-11-26
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2026-03-30
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2025-11-24
NAY System, Surgical, Computer Controlled Instrument Gastroenterology, Urology Class 2 876.1500 2025-11-25
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2025-11-26
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2025-11-26
LYU Accessory, Surgical Apparel General, Plastic Surgery Class 1 878.4040 2025-11-25
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2025-11-26
HQL Intraocular Lens Ophthalmic Class 3 886.3600 2025-11-24
POE Extended Depth Of Focus Intraocular Lens Ophthalmic Class 3 886.3600 2025-11-24
MJP Lens, Intraocular, Toric Optics Ophthalmic Class 3 886.3600 2025-11-24
MFK Lens, Multifocal Intraocular Ophthalmic Class 3 886.3600 2025-11-24
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2025-11-26
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2025-11-26
HET Laparoscope, Gynecologic (And Accessories) Obstetrics/Gynecology Class 2 884.1720 2025-11-26
KGZ Accessories, Catheter General, Plastic Surgery Class 1 878.4200 2025-11-25
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2025-11-26
FYA Gown, Surgical General, Plastic Surgery Class 2 878.4040 2026-04-24
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2025-11-24

Official Correspondent

No official correspondent registered.

US Agent Details

Becky Aldhizer Business: STERIS CORPROATIION 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
3010421104 STERIS TOMOE SINGAPORE PTE LTD Singapore South West, SG
3009882464 Synergy Health AST, LLC Saxonburg, PA, US
3007738736 Synergy Health AST, SRL Alajuela, CR
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
K880323 Medtronic Vascular MEDTRONIC MODEL 5411 SURGICAL CABLE ADAPTOR 1988-03-22
K913718 Abbott Laboratories PANCRETEC I.V. MODEL 5000 INFUS DEVICE, MODIFIED 1991-10-30
K840616 Advanced Bio Systems, Inc. MINI-PUMP U-100 1984-03-30
K850183 Deltec Systems, Inc. CADD-VT, 5300 AMBULATORY INFUSION PUMP W/3050, 50M 1985-03-13
K981246 Integra Neurocare, LLC BEVERLY REFERENTIAL VALVE (NL850-9710) WITH INTEGRAL PERITONEAL CATHETER (NL850-9720) VALVE KIT (NL850-9730) 1999-05-26

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
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Z-0002-2011 Baxter Healthcare Corp. Rt. 2
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Z-0005-2025 Zyno Medical LLC 2
Z-800 Infusion System, Model Numbers Z-800, Z-800F, Z-800W, Z-800WF; Software Version: Z-800 6.1.01 and 6-1.07z; Z-800F 4.1.02 and 4.1.08z; Z-800W 3.1.32 and 3.1.64z, Z-800WF 3.1.32 and 3.1.64z
Z-0006-2011 CareFusion Corporation 2
CareFusion Alaris PC Unit Model 8015 (formerly Medley PC Unit): Alaris PC Units (Model 8015) with logic board part number TC10005522 manufactured and serviced between December 20, 2008 and May 6, 2009; and Alaris PC Units (with logic board part number TC10005572 manufactured and serviced between May 7, 2009 and September 8, 2009. For use with Alaris infusion and monitoring systems.
Z-0007-2012 B Braun Medical, Inc 2
Outlook ES Safety Infusion System, Model 621-100ES, 621-200ES, 621-300ES, and 621-400ES B. Braun Medical Inc., 1601 Wallace Drive, Suite 150, Carrollton, TX 75006 The Outlook ES pump is intended for use with B. Braun Medical Inc., Horizon Pump IV Sets to regulate the flow of primary and secondary fluids when positive pressure is required.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017636737. Last updated year: 2026. Please use registration number 3017636737 when referencing this establishment in official correspondence.
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