Sdi Limited

Australia · Bayswater

✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, South Korea, 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

pendingnot queried

USUnited StatesFDA openFDA

16listed device types

Class I 6Class II 10Class III 0

plus 38 registration records and 9 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

39registered devices

Class I 7Class II 32

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

SASaudi ArabiaSFDA

10registered imported devices

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

CACanadaMDALL

0active device licences

19 including historic records

TWTaiwanTFDA

28valid device licences

Class I 2Class II 26

SGSingaporeHSA SMDR

16device registrations

CLASS B 16

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

43active ARTG entries

Class I 35IIa 8

HKHong KongMDACS

3valid listings

Class II 3

ILIsraelAMAR

2registrations

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 States38 registration records, 9 510(k), 0 PMA, 3 excluded

Brazil39 confirmed, 2 excluded

Saudi Arabia10 confirmed, 0 excluded

Manufacturer names merged into this page: SDI LTD. · SDI LIMITED · SDI Limited · SDI Ltd.,

Business registration

ABN: 27008075581
Registration status: Active
Legal form: Australian Public Company
Registered address: VIC, 3153

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

FDA 510(k) clearances by year

11984

12007

12008

12010

12018

12019

32022

FDA listed device types

showing 8 of 16

Sealant, Pit And Fissure, And Conditioner 1Dental Amalgam 1Alloy, Amalgam 1Cement, Dental 1Activator, Ultraviolet, For Polymerization 1Diammine Silver Fluoride Dental Hypersensitivity Varnish 1Material, Tooth Shade, Resin 1Mercury 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K222583	Stela Capsule System	2022-10-28
US	K222581	Stela Automix System	2022-10-28
US	K214118	Riva Cem Automix	2022-08-30
BR	82375629032	SET MAXX	Class II
BR	82375629001	POLA OFFICE PLUS	Class II
BR	82375620006	Radii	Class I
SA	ME0000007570SFDAA00042	Promix 2	—
SA	ME0000007570SFDAA00042	Promix 2	—

Sdi Limited

Registrations by market

How these numbers were verified

Company information

Business registration

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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