Scient'X

France · Guyancourt

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Canada, South Korea, Israel — 5 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

12510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 12 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

7registered devices

Class I 7

9 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

4active device licences

Class III 4

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

2registrations

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 States0 registration records, 12 510(k), 0 PMA, 1 excluded

Brazil7 confirmed, 0 excluded

Canada4 confirmed, 0 excluded

Manufacturer names merged into this page: SCIENT'X · SCIENT´X

Registration details (sample)

Market	Identifier	Name	Class / date
US	K071261	ISOBAR SEMI-RIGID DUAL DAMPENER	2008-04-17
US	K062912	SCIENT'X SPINAL SYSTEM	2007-02-05
US	K052763	STELLA CERVICAL PLATE	2005-11-10
BR	80263050017	CAIXAS E PARTES PARA ACOMODAÇÃO DE IMPLANTES E INSTRUMENTAIS SCIENT'X	Class I
BR	80263050004	Kit instrumental para espaçador expansível Scient 'X	Class I
BR	80263059002	Kit instrumental para fixação cervical Scient 'X	Class I
CA	1675	PCB CERVICAL SYSTEM	Class III
CA	2013	CC CAGE	Class III
CA	12773	ISOBAR TTL U-LINE	Class III

Scient'X

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

Registration details (sample)

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