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DIRECTA AB

Sweden · Upplands Vaesby Stockholm

✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Taiwan, Singapore, Australia, Israel, Russia — 7 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

32listed device types

Class I 28Class II 4Class III 0

plus 35 registration records and 1 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

1registered devices

Class I 1

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

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

12valid device licences

Class I 12

SGSingaporeHSA SMDR

1device registrations

CLASS B 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

28active ARTG entries

Class I 22IIa 6

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

6registrations

RURussiaRoszdravnadzor

3active registrations

Class 1 2Class 2a 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 States35 registration records, 1 510(k), 0 PMA

Brazil1 confirmed, 0 excluded

Manufacturer names merged into this page: DIRECTA AB

FDA 510(k) clearances by year

12015 · K133178

FDA listed device types

showing 8 of 32

Frame, Rubber Dam 1Elevator, Surgical, Dental 1Drill, Dental, Intraoral 1Absorber, Saliva, Paper 1Instruments, Dental Hand 1Dam, Rubber 1File, Pulp Canal, Endodontic 1Broach, Endodontic 1

Market	Identifier	Name	Class / date
US	K133178	LUXATOR LX HANDPIECE	2015-11-24
BR	10334210015	TrollFoil	Class I

DIRECTA AB

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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