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Olsen Industria E Comercio S.A.

Brazil · Palhoca Santa Catarina

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Australia, Russia — 4 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

7listed device types

Class I 7Class II 0Class III 0

plus 7 registration records and 2 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

9registered devices

Class I 9

10 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

1active ARTG entries

Class I 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

3active registrations

Class 1 1Class 2a 2

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 States7 registration records, 2 510(k), 0 PMA, 3 excluded

Brazil9 confirmed, 0 excluded

Saudi Arabia0 confirmed, 1 excluded

Canada0 confirmed, 3 excluded

Manufacturer names merged into this page: OLSEN INDUSTRIA E COMERCIO S/A · OLSEN INDUSTRIA E COMÉRCIO S/A

FDA 510(k) clearances by year

12020 · K180935

12022 · K213742

FDA listed device types

Chair, Surgical, Ac-Powered 1Controller, Foot, Handpiece And Cord 1Unit, Operative Dental 1Table, Examination, Medical, Powered 1Light, Operating, Dental 1Table, Powered 1Chair, Dental, Without Operative Unit 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K213742	Infinity Pro, Logic, Quality, Sprint	2022-10-19
US	K180935	Infinity / Infinity Cross Flex Dental Systems	2020-02-05
BR	10281300009	EQUIPAMENTO ODONTOLOGICO	Class I
BR	10281300010	Unidade Odontológica Transportável	Class I
BR	10281300013	CADEIRA MÉDICA AUTOMÁTICA PARA PROCEDIMENTOS OLSEN	Class I

Olsen Industria E Comercio S.A.

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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