Home›Denmark›3SHAPE TRIOS A/S

3SHAPE TRIOS A/S

Denmark · Copenhagen

✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, Australia, Hong Kong, Israel, Russia — 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

3listed device types

Class I 0Class II 3Class III 0

plus 4 registration records and 3 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

3registered devices

Class I 2Class II 1

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

SASaudi ArabiaSFDA

1registered imported devices

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

CACanadaMDALL

1active device licences

Class II 1

9 including historic records

TWTaiwanTFDA

2valid device licences

Class I 2

SGSingaporeHSA SMDR

2device registrations

CLASS B 2

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

7active ARTG entries

Class I 1IIa 4Class Im (measuring) 2

HKHong KongMDACS

1valid listings

Class II 1

ILIsraelAMAR

14registrations

RURussiaRoszdravnadzor

1active registrations

Class 1 1

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 States4 registration records, 3 510(k), 0 PMA

Brazil3 confirmed, 0 excluded

Saudi Arabia1 confirmed, 0 excluded

Canada1 confirmed, 0 excluded

Manufacturer names merged into this page: 3SHAPE TRIOS A/S · 3Shape TRIOS A/S

FDA 510(k) clearances by year

12022 · K221249

12025 · K242103

12026 · K260082

FDA listed device types

System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations 1Light-Induced Fluorescence Caries Detector 1Dental Image Analyzer, In-Office 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K260082	TRIOS Dx (R1)	2026-04-10
US	K242103	TRIOS Ready Tip	2025-04-04
US	K221249	L1P-1F (TRIOS 5)	2022-09-16
BR	81901719001	Scanner Intraoral TRIOS 3	Class I
BR	81901710005	Software 3Shape TRIOS Patient Monitoring	Class II
BR	81901710006	Scanner Intraoral TRIOS 5	Class I
SA	ME0000004659SFDAA00001	TRIOS® 3 Color	—
CA	103809	3SHAPE TRIOS DIAGNOSTIC AID	Class II

3SHAPE TRIOS A/S

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

Similar companies