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DeRoyal Industries, Inc.

✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, United Kingdom, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, Australia, Hong Kong, Israel — 10 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

0UDI-DI device records

USUnited StatesFDA openFDA

359listed device types

Class I 200Class II 151Class III 1unclassified 7

plus 1,994 registration records and 96 510(k)

UKUnited KingdomMHRA PARD

40registered device records

Class I 31Class IIa 3Class IIb 6

BRBrazilANVISA

30registered devices

Class I 7Class II 23

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

88registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

114active device licences

Class II 114

171 including historic records

TWTaiwanTFDA

1valid device licences

Class I 1

SGSingaporeHSA SMDR

3device registrations

CLASS B 3

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

27active ARTG entries

Class I 9IIa 4IIb 7Class Is (sterile) 7

HKHong KongMDACS

3valid listings

Class III 3

ILIsraelAMAR

13registrations

RURussiaRoszdravnadzor

pendingnot queried

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States1,994 registration records, 96 510(k), 0 PMA, 6 excluded

United Kingdom40 confirmed, 0 excluded

Brazil30 confirmed, 4 excluded

Saudi Arabia88 confirmed, 0 excluded

Canada114 confirmed, 0 excluded

Manufacturer names merged into this page: DEROYAL INDUSTRIES, INC. · DeRoyal Industries, Inc. · DEROYAL INDUSTRIES INC. · DeRoyal Industries · DEROYAL INDUSTRIES INC · DeRoyal Industries Inc

Regulatory identity

UK responsible person: MedEnvoy UK Limited

Business registration

LEI: 5493009C8ZDS7D3LZR40
Registration status: Active
Legal form: For-Profit Corporation (corp.)
Registered address: C/O Debusk, Autry O V, Knoxville, 37849
Registration authority: Business Services (Department of State), no. 000048405
Registry record updated: 2023-08-04

Business registration data from GLEIF, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

FDA 510(k) clearances by year

61992

21993

111994

71995

151996

101997

41998

11999

32003

12009

12010

12013

12014

12015

12016

12017

12018

52020

12024

12025

FDA listed device types

showing 8 of 359

Pad, Eye 1Device, Occlusion, Umbilical 1Container, Specimen, Sterile 1Solvent, Adhesive Tape 1Splint, Hand, And Components 1Toothbrush, Manual 1Needle, Aspiration And Injection, Disposable 1Insoles, Medical 1

Registration details (sample)

Market	Identifier	Name	Class / date
UK	16545	Control Syringe	Class I
UK	36206	Ankle Contracture Boot	Class I
UK	35818	Fall Alarm Pads	Class I
US	K250586	Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White Foam Accessory	2025-11-21
US	K230233	Prospera Spectruum Negative Pressure Wound Therapy System	2024-04-18
US	K200631	DeRoyal Temperature Monitoring Probe	2020-12-23
BR	80199339027	BOLSA COLETORA FLEXÍVEL	Class II
BR	80199339009	SONDA DE TEMPERATURA DE USO GERAL	Class II
BR	80199339010	SONDA DE TEMPERATURA DE PELE ADULTO	Class II
SA	ME0000001358SFDAA00047	Suture Boot	—
SA	ME0000001358SFDAA00002	Cervical Collar	—
CA	3968	HIP TRAY	Class II
CA	3973	KNEE TRAY	Class II
CA	3984	LAMINECTOMY TRAY	Class II