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AMPLITUDE SAS

France · Valence

✓ Record-verifiedregistrations found in 4 markets

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

24listed device types

Class I 23Class II 1Class III 0

plus 25 registration records and 2 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

33registered devices

Class I 32Class II 1

47 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

10 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

64active ARTG entries

Class I 2Class III 40IIa 16IIb 5Class Is (sterile) 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

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 States25 registration records, 2 510(k), 0 PMA

Brazil33 confirmed, 2 excluded

Manufacturer names merged into this page: AMPLITUDE · AMPLITUDE SAS

FDA 510(k) clearances by year

12017 · K161414

12023 · K230078

FDA listed device types

showing 8 of 24

Template 1Forceps 1Probe 1Chisel, Surgical, Manual 1Impactor 1Clamp, Surgical, General & Plastic Surgery 1Punch, Surgical 1Table, Surgical With Orthopedic Accessories, Manual 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K230078	TRAX® CR Total Knee System	2023-11-03
US	K161414	Anatomic Total Knee System	2017-01-19
BR	80726260082	Instrumental Cabo de Raspa Acetabular Reto - Conexão AO	Class I
BR	80726260083	Instrumental Cabo de Raspa Acetabular com Offset - Conexão AO	Class I
BR	80726260053	Instrumental Quadril - SATURNE® II - Versão Mecânica - Reto	Class I

AMPLITUDE SAS

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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