FDA Registration
Active
🇩🇴 Dominican Republic
STERIS Corporation de Republica Dominicana, S.R.L.
Reg #: 3017636737
·
FEI: 3017636737
·
Expires 2026
Products
90
Proprietary Names
39
Establishment Types
1
Classifications
90
Registration Details
- Registration Name
- STERIS Corporation de Republica Dominicana, S.R.L.
- Registration Number
- 3017636737
- FEI Number
- 3017636737
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Zona Franca Las Americas KM. 22 Autopista las Americas Santo Domingo Este, Calle 15 esq. Calle 10
- City
- Santo Domingo
- Country
- DO
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 CORPROATIION
- 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 |
|---|---|---|---|---|---|
| Cable, Transducer And Electrode, Patient, (Including Connector) | DSA | Class 2 | Cardiovascular | No | 2026-01-22 |
| Perforator, Ear-Lobe | JYS | Class 1 | Ear, Nose, Throat | No | 2026-04-28 |
| Pump, Infusion | FRN | Class 2 | General Hospital | No | 2025-11-24 |
| Shunt, Central Nervous System And Components | JXG | Class 2 | Neurology | No | 2025-11-26 |
| Stopcock, I.V. Set | FMG | Class 2 | General Hospital | No | 2025-11-24 |
| Light, Surgical, Accessories | FTA | Class 2 | General, Plastic Surgery | No | 2025-11-25 |
| Catheter, Continuous Flush | KRA | Class 2 | Cardiovascular | No | 2025-11-26 |
| Catheter, Percutaneous, Neurovasculature | QJP | Class 2 | Cardiovascular | No | 2025-11-26 |
| Port & Catheter, Implanted, Subcutaneous, Intraventricular | LKG | Class 2 | Neurology | No | 2025-11-26 |
| Device, Intravascular Catheter Securement | KMK | Class 1 | General Hospital | No | 2025-11-25 |
| Replacement, Ossicular Prosthesis, Total | ETA | Class 2 | Ear, Nose, Throat | No | 2025-11-25 |
| Clip, Implantable | FZP | Class 2 | General, Plastic Surgery | No | 2025-11-26 |
| Applier, Surgical, Clip | GDO | Class 1 | General, Plastic Surgery | No | 2025-11-26 |
| Instrument, Ultrasonic Surgical | LFL | Class U | Unknown | No | 2025-11-25 |
| Set, Tubing, Blood, With And Without Anti-Regurgitation Valve | FJK | Class 2 | Gastroenterology, Urology | No | 2025-11-24 |
| Accessories, Blood Circuit, Hemodialysis | KOC | Class 2 | Gastroenterology, Urology | No | 2025-11-24 |
| Set, Administration, Intravascular | FPA | Class 2 | General Hospital | No | 2025-11-24 |
| Catheter, Infusion | JCY | Class 1 | General, Plastic Surgery | No | 2025-11-25 |
| Replacement, Total Ossicular, Prosthesis, Porous, Polyethylene | LBN | Class 2 | Ear, Nose, Throat | No | 2025-11-25 |
| Tissue Expander And Accessories | LCJ | Class U | Unknown | No | 2025-11-25 |
| Dispenser, Liquid Medication | KYX | Class 1 | General Hospital | No | 2025-11-25 |
| Stimulator, Electrical, Evoked Response | GWF | Class 2 | Neurology | No | 2025-11-25 |
| Stimulator, Nerve | ETN | Class 2 | Ear, Nose, Throat | No | 2025-11-25 |
| Bag, Intestine | KGY | Class 1 | General, Plastic Surgery | No | 2025-11-25 |
| Set, I.V. Fluid Transfer | LHI | Class 2 | General Hospital | No | 2026-01-22 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2025-11-26 |
| Lens, Guide, Intraocular | KYB | Class 1 | Ophthalmic | No | 2025-11-24 |
| Prosthesis, Partial Ossicular Replacement | ETB | Class 2 | Ear, Nose, Throat | No | 2025-11-25 |
| Container, Specimen, Sterile | FMH | Class 1 | Pathology | No | 2025-11-25 |
| Introducer, Catheter | DYB | Class 2 | Cardiovascular | No | 2025-11-24 |
| Electromyograph, Diagnostic | IKN | Class 2 | Physical Medicine | No | 2025-11-25 |
| Tube, Aspirating, Flexible, Connecting | BYY | Class 2 | General Hospital | No | 2019-01-14 |
| Instrument, Biopsy | KNW | Class 2 | Gastroenterology, Urology | No | 2026-01-22 |
| Urinal | FNP | Class 1 | General Hospital | No | 2025-11-25 |
| Transducer, Pressure, Catheter Tip | DXO | Class 2 | Cardiovascular | No | 2022-01-04 |
| Gown, Surgical | FYA | Class 2 | General, Plastic Surgery | No | 2026-04-24 |
| Tube, Tympanostomy | ETD | Class 2 | Ear, Nose, Throat | No | 2025-11-25 |
| Button, Nasal Septal | LFB | Class U | Unknown | No | 2025-11-25 |
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2025-11-24 |
| Lens, Multifocal Intraocular | MFK | Class 3 | Ophthalmic | No | 2025-11-21 |
| Accessories, Catheter | KGZ | Class 1 | General, Plastic Surgery | No | 2025-11-25 |
| Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | DTL | Class 2 | Cardiovascular | No | 2025-11-24 |
| Splint, Intranasal Septal | LYA | Class 1 | Ear, Nose, Throat | No | 2025-11-25 |
| Suture, Nonabsorbable, Synthetic, Polyethylene | GAT | Class 2 | General, Plastic Surgery | No | 2025-11-25 |
| Bag, Bile Collecting | EXF | Class 2 | Gastroenterology, Urology | No | 2026-01-22 |
| Electrode, Needle | GXZ | Class 2 | Neurology | No | 2025-11-25 |
| System, Surgical, Computer Controlled Instrument | NAY | Class 2 | Gastroenterology, Urology | No | 2025-11-25 |
| Needle, Aspiration And Injection, Disposable | GAA | Class 1 | General, Plastic Surgery | No | 2025-11-25 |
| Instruments, Surgical, Cardiovascular | DWS | Class 1 | Cardiovascular | No | 2012-11-16 |
| Gouge, Surgical, General & Plastic Surgery | GDH | Class 1 | General, Plastic Surgery | No | 2025-11-26 |
| Drape, Surgical, Exempt | PUI | Class 2 | General, Plastic Surgery | No | 2025-11-25 |
| Needle, Tumor Localization | MIJ | Class 1 | General, Plastic Surgery | No | 2015-10-26 |
| Needle, Hypodermic, Single Lumen | FMI | Class 2 | General Hospital | No | 2025-11-24 |
| Modular Electromechanical Surgical System | SCV | Class 2 | General, Plastic Surgery | No | 2025-12-10 |
| Device, Monitoring, Intracranial Pressure | GWM | Class 2 | Neurology | No | 2025-11-26 |
| Table, Cystometric, Electric | MMZ | Class 2 | Gastroenterology, Urology | No | 2026-03-30 |
| General Surgery Tray | LRO | Class 2 | General, Plastic Surgery | No | 2026-04-24 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2026-04-24 |
| Nasopharyngoscope (Flexible Or Rigid) | EOB | Class 2 | Ear, Nose, Throat | No | 2025-11-25 |
| Porous Polyethylene Ossicular Replacement | LBM | Class 2 | Ear, Nose, Throat | No | 2025-11-25 |
| Intraocular Lens | HQL | Class 3 | Ophthalmic | No | 2025-11-24 |
| Catheter, Percutaneous, Intraspinal, Short Term | MAJ | Class 2 | Anesthesiology | No | 2025-11-26 |
| Drape, Urological, Disposable | EYY | Class 2 | General, Plastic Surgery | No | 2025-11-25 |
| Transducer, Blood-Pressure, Extravascular | DRS | Class 2 | Cardiovascular | No | 2025-11-24 |
| Staple, Implantable | GDW | Class 2 | General, Plastic Surgery | No | 2025-11-26 |
| System, Irrigation, Urological | LJH | Class 2 | Gastroenterology, Urology | No | 2025-11-25 |
| Anti Fog Solution And Accessories, Endoscopy | OCT | Class 2 | Gastroenterology, Urology | No | 2026-01-08 |
| Endoscopic Tissue Approximation Device | OCW | Class 2 | Gastroenterology, Urology | No | 2025-11-26 |
| Drape, Patient, Ophthalmic | HMT | Class 2 | General, Plastic Surgery | No | 2026-04-24 |
| Staple, Removable (Skin) | GDT | Class 1 | General, Plastic Surgery | No | 2025-11-26 |
| Transducer, Ultrasonic, Diagnostic | ITX | Class 2 | Radiology | No | 2026-03-30 |
| Extended Depth Of Focus Intraocular Lens | POE | Class 3 | Ophthalmic | No | 2025-11-24 |
| Lens, Intraocular, Toric Optics | MJP | Class 3 | Ophthalmic | No | 2025-11-24 |
| Laparoscope, Gynecologic (And Accessories) | HET | Class 2 | Obstetrics/Gynecology | No | 2025-11-26 |
| Table, Cysto, Non-Electrical | EYH | Class 1 | Gastroenterology, Urology | No | 2026-03-30 |
| Folders And Injectors, Intraocular Lens (Iol) | MSS | Class 1 | Ophthalmic | No | 2025-11-24 |
| Wire, Guide, Catheter | DQX | Class 2 | Cardiovascular | No | 2025-11-21 |
| Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material) | KHJ | Class 2 | Ear, Nose, Throat | No | 2025-11-26 |
| Catheter, Ventricular | HCA | Class 2 | Neurology | No | 2025-11-26 |
| Catheter And Tip, Suction | JOL | Class 2 | General Hospital | No | 2025-11-25 |
| Flowmeter, Blood, Cardiovascular | DPW | Class 2 | Cardiovascular | No | 2026-01-22 |
| Drape, Pure Latex Sheet, With Self-Retaining Finger Cot | EYX | Class 2 | General, Plastic Surgery | No | 2026-04-24 |
| Syringe, Irrigating (Non Dental) | KYZ | Class 1 | General Hospital | No | 2014-12-31 |
| Tubing, Noninvasive | GAZ | Class 2 | General Hospital | No | 2013-02-12 |
| Suture, Nonabsorbable, Synthetic, Polyamide | GAR | Class 2 | General, Plastic Surgery | No | 2025-11-26 |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | Class 2 | Radiology | No | 2025-11-25 |
| Tester, Pacemaker Electrode Function | DTA | Class 2 | Cardiovascular | No | 2026-01-22 |
| Drape, Surgical, Ent | ERY | Class 2 | General, Plastic Surgery | No | 2026-04-24 |
| Neurological Stereotaxic Instrument | HAW | Class 2 | Neurology | No | 2025-11-25 |
| Laryngoscope, Endoscope | GCI | Class 2 | Gastroenterology, Urology | No | 2025-11-26 |
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) - Mendaera
DAS MEDICAL (DR) - Schaerer Medical
Conmed (SX) - PLUMEPORT
Conmed (SX) - FUMOVAC
Conmed (SX) - OR-VAC
Conmed (SX) - TUBING, NONINVASIVE
Conmed (SX) - HARMONYAIR
Conmed (SX) - VALLEYLAB OPTIMUMM SMOKE EVACUATOR SYSTEM
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)