Satelec

France · Wellesley

✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Brazil, Singapore, South Korea, Israel, Russia — 6 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

24510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 24 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

4registered devices

Class I 1Class II 3

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

0valid device licences

SGSingaporeHSA SMDR

5device registrations

CLASS B 4CLASS C 1

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

4registrations

RURussiaRoszdravnadzor

1active registrations

Class 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 States0 registration records, 24 510(k), 0 PMA, 3 excluded

Brazil4 confirmed, 2 excluded

Canada0 confirmed, 1 excluded

Manufacturer names merged into this page: SATELEC

Registration details (sample)

Market	Identifier	Name	Class / date
US	K110379	AIR-N-GO	2011-12-08
US	K100410	PIEZOELECTRIC SYSTEM	2010-04-28
US	K091331	PIEZOTOME 2	2009-12-11
BR	80840260011	PONTAS SATELEC	Class II
BR	80145901755	Família de Instrumental Não Articulado Cortante PT - Estéril	Class II
BR	80145901756	Família de Instrumental Não Articulado Não Cortante PT - Estéril	Class II

Satelec

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

Registration details (sample)

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