Data / Medical devices / Dominican Republic / Deroyal Intercontinental, S.R.L.
Deroyal Intercontinental, S.R.L.: FDA-registered device maker in Santiago, Dominican Republic, 21 510(k) clearances
Deroyal Intercontinental, S.R.L. is registered with the FDA (registration 3004605321) in Santiago, Dominican Republic. It lists 95 device types. The FDA files 21 510(k) clearances under its listings, the newest dated August 19, 2011. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004605321
- Address
- KM 7, Autopista Joaquin Balaguer Pisano Free Zone, Building 49, Santiago, Dominican Republic, 5100
- Owner or operator
- DEROYAL INDUSTRIES, INC. (1044833)
- Roles
- Contract manufacturer, Exporter to the US, Repackager or relabeler
- First device listed
- January 4, 1994
- Registered through
- 2026
- Brand names listed
- Accessories, Catheter - DeRoyal, Accessories, Traction - DeRoyal, Accessory Equipment, Cardiopulmonary Bypass - DeRoyal, Accessory, Surgical Apparel - DeRoyal, Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass - DeRoyal, Anesthesia Conduction Kit - Needle, Conduction, Anesthetic (w/wo Introducer) - DeRoyal, Angiography/Angioplasty Kit - DeRoyal, Anti Fog Solution and Accessories, Endoscopy - DeRoyal and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|
| Accessories, Catheter | KGZ | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Accessories, Traction | ILZ | 1 | Contract manufacturer | accessdata.fda.gov |
| Accessory Equipment, Cardiopulmonary Bypass | KRI | 1 | Contract manufacturer | accessdata.fda.gov |
| Accessory, Surgical Apparel | LYU | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | DTL | 2 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Anesthesia Conduction Kit | CAZ | 2 | Contract manufacturer | accessdata.fda.gov |
| Angiography/Angioplasty Kit | OEQ | 2 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Anti Fog Solution And Accessories, Endoscopy | OCT | 2 | Contract manufacturer | accessdata.fda.gov |
| Applicator, Absorbent Tipped, Non-Sterile | KXF | 1 | Repackager or relabeler | accessdata.fda.gov |
| Applicator, Absorbent Tipped, Sterile | KXG | 1 | Repackager or relabeler | accessdata.fda.gov |
| Bandage, Cast | ITG | 1 | Contract manufacturer | accessdata.fda.gov |
| Bandage, Elastic | FQM | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Basin, Emesis | FNY | 1 | Repackager or relabeler | accessdata.fda.gov |
| Binder, Abdominal | FSD | 1 | Contract manufacturer | accessdata.fda.gov |
| Blade, Scalpel | GES | 1 | Repackager or relabeler | accessdata.fda.gov |
| Blood Pressure Cuff | DXQ | 2 | Contract manufacturer | accessdata.fda.gov |
| Bottle, Collection, Vacuum | KDQ | 2 | Repackager or relabeler | accessdata.fda.gov |
| Catheter, Intravascular, Diagnostic | DQO | 2 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Catheter, Irrigation | GBX | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Catheter, Urological | KOD | 2 | Contract manufacturer | accessdata.fda.gov |
| Clamp, Surgical, General & Plastic Surgery | GDJ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Connector, Catheter | GCD | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Container, Empty, For Collection & Processing Of Blood & Blood Components | KSR | 2 | Contract manufacturer | accessdata.fda.gov |
| Container, I.V. | KPE | 2 | Repackager or relabeler | accessdata.fda.gov |
| Container, Specimen, Non-Sterile | NNI | 1 | Repackager or relabeler | accessdata.fda.gov |
| Container, Specimen, Sterile | FMH | 1 | Repackager or relabeler | accessdata.fda.gov |
| Cotton, Roll | EFN | 1 | Contract manufacturer | accessdata.fda.gov |
| Cover, Limb | IPM | 1 | Contract manufacturer | accessdata.fda.gov |
| Device, Occlusion, Umbilical | FOD | 1 | Contract manufacturer | accessdata.fda.gov |
| Dispenser, Liquid Medication | KYX | 1 | Repackager or relabeler | accessdata.fda.gov |
| Dissector, Surgical, General & Plastic Surgery | GDI | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Drape, Surgical, Exempt | PUI | 2 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Dressing Change Tray | OXQ | 1 | Contract manufacturer | accessdata.fda.gov |
| Dressing, Compression | MHW | 1 | Contract manufacturer | accessdata.fda.gov |
| Dressing, Wound, Occlusive | NAD | 1 | Repackager or relabeler | accessdata.fda.gov |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 2 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Fiber, Medical, Absorbent | FRL | 1 | Repackager or relabeler | accessdata.fda.gov |
| Forceps, General & Plastic Surgery | GEN | 1 | Repackager or relabeler | accessdata.fda.gov |
| Gauze / Sponge,Nonresorbable For External Use | NAB | 1 | Repackager or relabeler | accessdata.fda.gov |
| Gauze/Sponge, Internal | EFQ | U | Repackager or relabeler | accessdata.fda.gov |
| Gauze/Sponge, Internal, X-Ray Detectable | GDY | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| General Surgery Tray | LRO | 2 | Contract manufacturer | accessdata.fda.gov |
| Halter, Head, Traction | HSS | 1 | Contract manufacturer | accessdata.fda.gov |
| Handle, Scalpel | GDZ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Hemostat | HRQ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Holder, Needle, Gastroenterologic | FHQ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Injector And Syringe, Angiographic | DXT | 2 | Contract manufacturer | accessdata.fda.gov |
| Instrument, Cranioplasty Material Forming | HBX | 1 | Repackager or relabeler | accessdata.fda.gov |
| Instrument, Manual, Surgical, General Use | MDM | 1 | Contract manufacturer, Exporter to the US | accessdata.fda.gov |
| Instrument, Surgical, Disposable | KDC | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Instruments, Surgical, Cardiovascular | DWS | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Insufflator, Laparoscopic | HIF | 2 | Repackager or relabeler | accessdata.fda.gov |
| Joint, Ankle, External Brace | ITW | 1 | Contract manufacturer | accessdata.fda.gov |
| Joint, Knee, External Brace | ITQ | 1 | Contract manufacturer | accessdata.fda.gov |
| Kit, Surgical Instrument, Disposable | KDD | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Laparoscope, General & Plastic Surgery | GCJ | 2 | Contract manufacturer | accessdata.fda.gov |
| Laparoscopy Kit | FDE | 2 | Contract manufacturer | accessdata.fda.gov |
| Light, Surgical, Accessories | FTA | 2 | Contract manufacturer | accessdata.fda.gov |
| Marker, Skin | FZZ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Monitor, Bed Patient | KMI | 1 | Contract manufacturer | accessdata.fda.gov |
| Needle, Conduction, Anesthetic (W/Wo Introducer) | BSP | 2 | Contract manufacturer | accessdata.fda.gov |
| Needle, Hypodermic, Single Lumen | FMI | 2 | Repackager or relabeler | accessdata.fda.gov |
| Negative Pressure Wound Therapy Powered Suction Pump | OMP | 2 | Contract manufacturer | accessdata.fda.gov |
| Orthosis, Cervical | IQK | 1 | Contract manufacturer | accessdata.fda.gov |
| Orthosis, Limb Brace | IQI | 1 | Contract manufacturer | accessdata.fda.gov |
| Orthosis, Lumbo-Sacral | IPY | 1 | Contract manufacturer | accessdata.fda.gov |
| Pack, Hot Or Cold, Disposable | IMD | 1 | Contract manufacturer | accessdata.fda.gov |
| Pack, Hot Or Cold, Reusable | IME | 1 | Contract manufacturer | accessdata.fda.gov |
| Pack, Hot Or Cold, Water Circulating | ILO | 2 | Contract manufacturer | accessdata.fda.gov |
| Pneumoperitoneum Needle | FHO | 2 | Repackager or relabeler | accessdata.fda.gov |
| Probe | HXB | 1 | Repackager or relabeler | accessdata.fda.gov |
| Protector, Skin Pressure | FMP | 1 | Contract manufacturer | accessdata.fda.gov |
| Restraint, Protective | FMQ | 1 | Contract manufacturer | accessdata.fda.gov |
| Scissors, General, Surgical | LRW | 1 | Repackager or relabeler | accessdata.fda.gov |
| Scissors, Medical, Disposable | JOK | 1 | Repackager or relabeler | accessdata.fda.gov |
| Set, Administration, Intravascular | FPA | 2 | Repackager or relabeler | accessdata.fda.gov |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | HOY | 1 | Contract manufacturer | accessdata.fda.gov |
| Shoe, Cast | IPG | 1 | Contract manufacturer | accessdata.fda.gov |
| Skin Prep Tray | OJU | 1 | Contract manufacturer | accessdata.fda.gov |
| Slides, Microscope | KEW | 1 | Repackager or relabeler | accessdata.fda.gov |
| Sling, Arm | ILI | 1 | Contract manufacturer | accessdata.fda.gov |
| Snare, Surgical | GAE | 1 | Contract manufacturer | accessdata.fda.gov |
| Splint, Extremity, Inflatable, External | FZF | 1 | Contract manufacturer | accessdata.fda.gov |
| Splint, Hand, And Components | ILH | 1 | Contract manufacturer | accessdata.fda.gov |
| Sponge, Ophthalmic | HOZ | 2 | Contract manufacturer | accessdata.fda.gov |
| Support, Arm | IOY | 1 | Contract manufacturer | accessdata.fda.gov |
| Suture Removal Kit | MCZ | 1 | Contract manufacturer | accessdata.fda.gov |
| Syringe, Piston | FMF | 2 | Repackager or relabeler | accessdata.fda.gov |
| Tape And Bandage, Adhesive | KGX | 1 | Repackager or relabeler | accessdata.fda.gov |
| Tourniquet Kit | OJS | 1 | Contract manufacturer | accessdata.fda.gov |
| Tourniquet, Nonpneumatic | GAX | 1 | Contract manufacturer | accessdata.fda.gov |
| Transducer, Blood-Pressure, Extravascular | DRS | 2 | Repackager or relabeler | accessdata.fda.gov |
| Tubing, Pressure And Accessories | BYX | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Tubing/Tubing With Filter, Insufflation, Laparoscopic | NKC | 1 | Contract manufacturer | accessdata.fda.gov |
| Wire, Guide, Catheter | DQX | 2 | Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|
| August 19, 2011 | K111441 | UNIMAX VERESS NEEDLE | HIF | Substantially Equivalent | Unimax Medical Systems, Inc. | accessdata.fda.gov |
| July 16, 2007 | K070936 | WELMED HYPODERMIC SYRINGE | FMF | Substantially Equivalent | Welmed, Inc. | accessdata.fda.gov |
| September 19, 2006 | K061573 | TRANSPAC III DISPOSABLE STRAIGHT PRESSURE TRANSDUCER AND KIT | DRS | Substantially Equivalent | Hospira, Inc. | accessdata.fda.gov |
| March 4, 2004 | K033301 | IV ADMINISTRATION AND CONNECT SETS | FPA | Substantially Equivalent | Codan US Corp. | accessdata.fda.gov |
| March 7, 2003 | K030339 | CAUTERY TIP CLEANER, MODEL-TC-100 | GEI | Substantially Equivalent | Aspen Surgical Products, Inc. | accessdata.fda.gov |
| March 28, 2002 | K013714 | CODAN US I.V. ADMINISTRATION SET, MODEL B400 SP | FPA | Substantially Equivalent | Codan US Corp. | accessdata.fda.gov |
| September 7, 2000 | K001872 | I.V. SET-LUER LOCK WITH LATEX FREE INJECTION SITE, MODEL B411 | FPA | Substantially Equivalent | Codan US Corp. | accessdata.fda.gov |
| August 20, 1998 | K981747 | BIOTRANS PRESSURE MONITORING KIT MODEL NUMBER BT XXXXXX | DRS | Substantially Equivalent | Sunscope Intl., Inc. | accessdata.fda.gov |
| July 21, 1998 | K982123 | CONTRAST CONTROL DEVICE | FPA | Substantially Equivalent | Medex, Inc. | accessdata.fda.gov |
| June 11, 1998 | K980987 | BECTON DICKINSON SYRINGE | FMF | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic | accessdata.fda.gov |
| October 7, 1995 | K951254 | SAFETYGLIDE NEEDLE | FMI | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic | accessdata.fda.gov |
| March 31, 1994 | K935170 | CARDIOVASCULAR AND VASCULAR GUIDEWIRE MODIFICATIONS | DQX | Substantially Equivalent | Lake Region Mfg., Inc. | accessdata.fda.gov |
| January 12, 1994 | K935835 | BUSSE PLASTIC TUBING CONNECTORS AND ACCESSORIES | BYX | Substantially Equivalent | Busse Hospital Disposables, Inc. | accessdata.fda.gov |
| December 11, 1992 | K920977 | MERITRANS(TM) DISPOSABLE TRANSDUCER | DRS | Substantially Equivalent | Merit Medical Systems, Inc. | accessdata.fda.gov |
| November 25, 1991 | K913871 | FLOSWITCH(R) HP | DQO | Substantially Equivalent | Boston Scientific Corp | accessdata.fda.gov |
| February 4, 1986 | K854547 | MONOJECT STERILE M200 ALUMINUM/M250 POLYPROPYLENE | FMI | Substantially Equivalent | Sherwood Medical Co. | accessdata.fda.gov |
| July 11, 1985 | K851834 | MANAN GWI GUIDE WIRE INTRODUCER | DWS | Substantially Equivalent | Manan Manufacturing Co., Inc. | accessdata.fda.gov |
| June 17, 1981 | K811233 | I.V. PLASTIC BAG | KPE | Substantially Equivalent | Medi-Plast Intl., Inc. | accessdata.fda.gov |
| November 5, 1979 | K791871 | NEUROLOGICAL SPONGES (PATTIES) | EFQ | Substantially Equivalent | Carwild Corp. | accessdata.fda.gov |
| April 10, 1979 | K790062 | IV ADMINISTRATION SET WITH BACKCHECK | FPA | Substantially Equivalent | National Patent Development Corp. | accessdata.fda.gov |
| January 23, 1979 | K782095 | STOPCOCKS, MANIFOLDS | DTL | Substantially Equivalent | Namic | accessdata.fda.gov |
Compare with other makers
- All makers of Scissors, Medical, Disposable
- All makers of Transducer, Blood-Pressure, Extravascular
- All makers of Tape And Bandage, Adhesive
- All makers of Scissors, General, Surgical
- All makers of Catheter, Intravascular, Diagnostic
- All makers of Wire, Guide, Catheter
Updated August 19, 2011. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.