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Newdeal Sas

France · Saint-Priest

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Canada, 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

10510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 10 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

8registered devices

Class I 6Class II 2

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

25active device licences

Class II 8Class III 17

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

2active registrations

Class 1 1Class 3 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, 10 510(k), 0 PMA

Brazil8 confirmed, 0 excluded

Canada25 confirmed, 0 excluded

Manufacturer names merged into this page: NEWDEAL SAS · NEWDEAL

Registration details (sample)

Market	Identifier	Name	Class / date
US	K103623	NEWDEAL INTERPHALANGEAL IMPLANT	2012-03-20
US	K093914	NEWDEAL COMPRESSION PLATES	2011-04-14
US	K093781	MODIFIED: NEWDEAL HALLU PLATES	2010-01-22
BR	80043770005	ACHILLON	Class II
BR	80043770008	K-FIX - EXTREMIDADE PROTETORA DAS AGULHAS KRISCHNER	Class I
BR	80124810003	CONJUNTO DE INSTRUMENTAIS PARA CIRURGIA DE PÉ PLANO NEWDEAL	Class I
CA	28401	BOLD SCREW	Class III
CA	30919	SPIN SNAP-OFF SCREW	Class III
CA	30925	I.CO.S SCREW	Class III

Newdeal Sas

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

Registration details (sample)

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