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SEDATELEC

France · Irigny

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Canada, Australia, Israel — 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

4listed device types

Class I 2Class II 2Class III 0

plus 4 registration records and 4 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

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

7active device licences

Class II 6Class III 1

15 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

6active ARTG entries

Class I 1IIa 5

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

3registrations

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 States4 registration records, 4 510(k), 0 PMA

Canada7 confirmed, 0 excluded

Manufacturer names merged into this page: SEDATELEC

FDA 510(k) clearances by year

21999 · K983800

12006 · K060392

12010 · K101267

FDA listed device types

Device, Pressure Applying 1Light, Examination, Medical, Battery Powered 1Lamp, Infrared, Therapeutic Heating 1Needle, Acupuncture, Single Use 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K101267	PREMIO 10 MOXA	2010-12-03
US	K060392	ASP TITANIUM	2006-04-26
US	K983800	DN ACUPUNTURE NEEDLES	1999-08-27
CA	3138	STIMULATEURS LASER	Class III
CA	3154	DETECTEURS/STIMULATEURS DE POINTS	Class II
CA	3156	AIGUILLE STERILE A USAGE UNIQUE POUR ELECTROLIPOLYSE ASE	Class II

SEDATELEC

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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