Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004605321

FEI Number

3004605321

Entity Name

DEROYAL INTERCONTINENTAL, S.R.L.

City/State/Country

SANTIAGO, DO

Establishment Address

KM 7, Autopista Joaquin Balaguer, Pisano Free Zone, Building 49, SANTIAGO 5100, DO

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

DEROYAL INDUSTRIES, INC. (Owner Number: 1044833)

Owner / Operator Contact Address

200 DEBUSK LN., --, Powell, TN 37849, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K920977

PMA Number

N/A

All Registered Proprietary Names

Orthosis, Limb Brace - DeRoyal Basin, Emesis - DeRoyal Laparoscopy Kit - DeRoyal Blade, Scalpel - DeRoyal Container, Specimen, Sterile - DeRoyal Syringe, Piston - DeRoyal Instrument, Surgical, Disposable - DeRoyal Kit, Surgical Instrument, Disposable - DeRoyal Tubing, Pressure and Accessories - DeRoyal Negative Pressure Wound Therapy Powered Suction Pump - DeRoyal Instrument, Manual, Surgical, General Use - DeRoyal Blood Pressure Cuff - DeRoyal Electrosurgical, Cutting & Coagulation & Accessories - DeRoyal Catheter, Irrigation - DeRoyal Dispenser, Liquid Medication - DeRoyal Container, Empty, for Collection & Processing of Blood & Blood Components - DeRoyal Forceps, General & Plastic Surgery - DeRoyal BLOOD PRESSURE CUFF - DeRoyal Accessories, Traction - DeRoyal Injector and Syringe, Angiographic - DeRoyal Instruments, Surgical, Cardiovascular - DeRoyal Scissors, Medical, Disposable - DeRoyal Orthosis, Lumbo-Sacral - DeRoyal Oxygenator, Cardiopulmonary Bypass - DeRoyal DEROYAL THERMO-COLD S Pack, Hot and Cold, Disposable - DeRoyal Protector, Skin Pressure - DeRoyal Restraint, Protective - DeRoyal Set, Administration, Intravascular - DeRoyal Anti Fog Solution and Accessories, Endoscopy - DeRoyal Support, Arm - DeRoyal Angiography/Angioplasty Kit - DeRoyal Tubing, Pressure and Accessories - DeRoyal Set, Administration, Intravascular - DeRoyal Dressing, Wound, Occlusive - DeRoyal Orthosis, Cervical - DeRoyal Gauze/Sponge, Internal - DeRoyal Pack, Hot or Cold, Reuseable - DeRoyal Dissector, Surgical, General & Plastic Surgery - DeRoyal Tourniquet Kit - DeRoyal Marker, Skin - DeRoyal Bandage, Elastic - DeRoyal Shoe, Cast - DeRoyal Needle, Hypodermic, Single Lumen - DeRoyal Transducer, Blood-Pressure, Extravascular - DeRoyal Instrument, Cranioplasty Material Forming - DeRoyal Skin Prep Tray (Kit)- DeRoyal Container, I. V. - DeRoyal Dressing Change Tray - DeRoyal Device, Occlusion, Umbilical - DeRoyal Scissors, General, Surgical - DeRoyal Catheter, Urological - DeRoyal Catheter, Intravascular, Diagnostic - DeRoyal Probe - DeRoyal Light, Surgical, Accessories - DeRoyal Set, Administration, Intravascular - DeRoyal Handle, Scalpel - DeRoyal Tubing/Tubing with Filter, Insufflation, Laparoscopic - DeRoyal Needle, Hypodermic, Single Lumen - DeRoyal Splint, Hand, and Components - DeRoyal WRIST MICROSCOPE SLIDES - DeRoyal Set, administration, intravascular - DeRoyal Snare, Surgical - DeRoyal Wire, Guide, Catheter - DeRoyal Splint, Extremity, Inflatable, External - DeRoyal Connector, Catheter - DeRoyal Drape, Surgical, Exempt - DeRoyal Joint, Knee, External Brace - DeRoyal Accessory, Surgical Apparel - DeRoyal Cotton, Roll - DeRoyal Monitor, Bed Patient - DeRoyal Gauze/Sponge, Internal, X-Ray Detectable - DeRoyal Pack, Hot or Cold, Water Circulating - DeRoyal Set, Administration, Intravascular - DeRoyal Hemostat - DeRoyal Catheter, Intravascular, Diagnostic - DeRoyal Pneumoperitoneum Needle - DeRoyal Transducer, Blood-Pressure, Extravascular - DeRoyal

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	2006-06-20
FNY	Basin, Emesis	General Hospital	Class 1	880.6730	2001-05-16
FDE	Laparoscopy Kit	Gastroenterology, Urology	Class 2	876.1500	2016-03-07
GES	Blade, Scalpel	General, Plastic Surgery	Class 1	878.4800	1998-08-19
FMH	Container, Specimen, Sterile	Pathology	Class 1	864.3250	2004-03-03
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2016-01-14
KDC	Instrument, Surgical, Disposable	General, Plastic Surgery	Class 1	878.4800	2001-02-21
KDD	Kit, Surgical Instrument, Disposable	General, Plastic Surgery	Class 1	878.4800	2001-08-03
BYX	Tubing, Pressure And Accessories	Anesthesiology	Class 1	868.5860	2012-09-20
OMP	Negative Pressure Wound Therapy Powered Suction Pump	General, Plastic Surgery	Class 2	878.4780	2023-10-06
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2006-08-22
DXQ	Blood Pressure Cuff	Cardiovascular	Class 2	870.1120	2016-07-25
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2013-09-05
GBX	Catheter, Irrigation	General, Plastic Surgery	Class 1	878.4200	2005-04-20
KYX	Dispenser, Liquid Medication	General Hospital	Class 1	880.6430	2005-08-25
KSR	Container, Empty, For Collection & Processing Of Blood & Blood Components	Hematology	Class 2	864.9100	2009-12-30
GEN	Forceps, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2001-08-03
DXQ	Blood Pressure Cuff	Cardiovascular	Class 2	870.1120	2006-06-20
ILZ	Accessories, Traction	Physical Medicine	Class 1	890.5925	2015-09-21
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2016-03-30
DWS	Instruments, Surgical, Cardiovascular	Cardiovascular	Class 1	870.4500	2012-09-04
JOK	Scissors, Medical, Disposable	General Hospital	Class 1	880.6820	1998-08-07
IPY	Orthosis, Lumbo-Sacral	Physical Medicine	Class 1	890.3490	2006-06-20
DTL	Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4290	2012-12-28
IMD	Pack, Hot Or Cold, Disposable	Physical Medicine	Class 1	890.5710	2006-08-09
FMP	Protector, Skin Pressure	General Hospital	Class 1	880.6450	2006-07-27
FMQ	Restraint, Protective	General Hospital	Class 1	880.6760	2015-09-15
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2025-08-26
OCT	Anti Fog Solution And Accessories, Endoscopy	Gastroenterology, Urology	Class 2	876.1500	2009-08-24
IOY	Support, Arm	Physical Medicine	Class 1	890.3475	2015-09-21
OEQ	Angiography/Angioplasty Kit	Cardiovascular	Class 2	870.1650	2016-03-07
BYX	Tubing, Pressure And Accessories	Anesthesiology	Class 1	868.5860	2004-11-03
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2015-11-09
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2004-12-09
IQK	Orthosis, Cervical	Physical Medicine	Class 1	890.3490	2006-06-20
EFQ	Gauze/Sponge, Internal	Unknown	Class U	N/A	2010-01-29
IME	Pack, Hot Or Cold, Reusable	Physical Medicine	Class 1	890.5700	2001-08-03
GDI	Dissector, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2001-08-03
OJS	Tourniquet Kit	General, Plastic Surgery	Class 1	878.5900	2016-02-08
FZZ	Marker, Skin	General, Plastic Surgery	Class 1	878.4660	2006-08-22
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2006-08-09
IPG	Shoe, Cast	Physical Medicine	Class 1	890.3025	2006-06-20
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2016-01-14
DRS	Transducer, Blood-Pressure, Extravascular	Cardiovascular	Class 2	870.2850	2012-09-04
HBX	Instrument, Cranioplasty Material Forming	Neurology	Class 1	882.4500	2024-11-12
OJU	Skin Prep Tray	General, Plastic Surgery	Class 1	878.4800	2016-03-07
KPE	Container, I.V.	General Hospital	Class 2	880.5025	2024-01-15
OXQ	Dressing Change Tray	General Hospital	Class 1	880.5075	2015-12-10
FOD	Device, Occlusion, Umbilical	General Hospital	Class 1	880.5950	1997-02-12
LRW	Scissors, General, Surgical	General, Plastic Surgery	Class 1	878.4800	2004-12-09
KOD	Catheter, Urological	Gastroenterology, Urology	Class 2	876.5130	2012-09-17
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2008-12-17
HXB	Probe	Orthopedic	Class 1	888.4540	2026-01-13
FTA	Light, Surgical, Accessories	General, Plastic Surgery	Class 2	878.4580	2015-09-22
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2025-08-26
GDZ	Handle, Scalpel	General, Plastic Surgery	Class 1	878.4800	2012-09-17
NKC	Tubing/Tubing With Filter, Insufflation, Laparoscopic	Obstetrics/Gynecology	Class 1	884.1730	2009-08-21
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2024-01-16
ILH	Splint, Hand, And Components	Physical Medicine	Class 1	890.3475	2006-06-20
KEW	Slides, Microscope	Pathology	Class 1	864.3010	2004-07-12
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2007-12-19
GAE	Snare, Surgical	General, Plastic Surgery	Class 1	878.4800	2005-09-28
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2015-11-09
FZF	Splint, Extremity, Inflatable, External	General, Plastic Surgery	Class 1	878.3900	2014-07-29
GCD	Connector, Catheter	General, Plastic Surgery	Class 1	878.4200	2012-09-25
PUI	Drape, Surgical, Exempt	General, Plastic Surgery	Class 2	878.4370	2017-08-01
ITQ	Joint, Knee, External Brace	Physical Medicine	Class 1	890.3475	2006-06-20
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2005-08-25
EFN	Cotton, Roll	Dental	Class 1	872.6050	2004-10-15
KMI	Monitor, Bed Patient	General Hospital	Class 1	880.2400	2014-02-10
GDY	Gauze/Sponge, Internal, X-Ray Detectable	General, Plastic Surgery	Class 1	878.4450	2006-08-22
ILO	Pack, Hot Or Cold, Water Circulating	Physical Medicine	Class 2	890.5720	1997-02-28
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2025-08-26
HRQ	Hemostat	General, Plastic Surgery	Class 1	878.4800	2006-08-22
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2007-12-19
HIF	Insufflator, Laparoscopic	Obstetrics/Gynecology	Class 2	884.1730	2016-06-22
FHO	Pneumoperitoneum Needle	Gastroenterology, Urology	Class 2	876.1500	2016-06-22
DRS	Transducer, Blood-Pressure, Extravascular	Cardiovascular	Class 2	870.2850	2025-08-26

Official Correspondent

Elizabeth Reed

US Agent Details

Elizabeth Reed Business: DeRoyal Industries, Inc. Email: ereed@deroyal.com Phone: (865) 3621256

Related Public Records

Same Entity

DEROYAL INDUSTRIES, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3008583452	DeRoyal Industries, Inc.	Powell, TN, US
1051550	DEROYAL INDUSTRIES, INC.	MAYNARDVILLE, TN, US
1057404	DeRoyal Industries, Inc.	POWELL, TN, US
1034876	DEROYAL INDUSTRIES, INC.	MAYNARDVILLE, TN, US
3021190810	DePre, LLC	Powell, TN, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K880350	Honway International Co.	YUE/FA DISPOSABLE SYRINGE	1988-02-16
K003571	Terumo Medical Corp.	SERONO FOR USE WITH GONAL-F 1200IU MULTI-DOSE ONLY AT 600IU/ML SYRINGE	2001-02-12
K831798	I M, Inc.	DISPOSABLE SCALPELS	1983-07-19
K831001	Frontier Products	UNICUFF-BLOOD PRESSURE CUFF	1983-07-28
K253089	Shenzhen Best Electronics Co., Ltd.	NIBP Cuff (BCS-112, BCS-212, BCS-312, BCS-412, BCS-512, BCS-612, BCS-712, BCS-122, BCS-222, BCS-322, BCS-422, BCS-522, BCS-622, BCS-722, BCD-112, BCD-212, BCD-312, BCD-412, BCD-512, BCD-612, BCD-712, BCD-122, BCD-222, BCD-322, BCD-422, BCD-522, BCD-622, BCD-722)	2026-02-13

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0012-2008	Becton Dickinson & Company	1	Shelf Pack: Bard-Parker Rib-Back Carbon Steel no.11, surgical blade. Unit Package: Contents of unopened or undamaged package guaranteed sterile; After use place product in a puncture resistant container and dispose properly. Becton Dickinson Becton Dickinson Acute Care Franklin Lakes, NJ 07417
Z-0013-2008	Becton Dickinson & Company	1	Shelf Pack: Bard-Parker Rib-Back Stainless Steel no.11, surgical blade. Unit Package: Contents of unopened or undamaged package guaranteed sterile; After use place product in a puncture resistant container and dispose properly. Becton Dickinson Becton Dickinson Acute Care Franklin Lakes, NJ 07417
Z-0003-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 30G X 5/16'' syringes
Z-0004-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1 cc X 29G X 1/2 '' insulin syringes
Z-0005-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 29G X 1/2 '' insulin syringes

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004605321. Last updated year: 2026. Please use registration number 3004605321 when referencing this establishment in official correspondence.