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MAILLEFER INSTRUMENTS HOLDING SARL

Switzerland · Ballaigues

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, South Korea — 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

32listed device types

Class I 20Class II 11Class III 0unclassified 1

plus 34 registration records and 1 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

36registered devices

Class I 15Class II 21

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

13registered imported devices

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

CACanadaMDALL

0active device licences

13 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

pendingnot queried

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 States34 registration records, 1 510(k), 0 PMA

Brazil36 confirmed, 0 excluded

Saudi Arabia13 confirmed, 0 excluded

Canada0 confirmed, 1 excluded

Manufacturer names merged into this page: MAILLEFER INSTRUMENTS HOLDING SARL · MAILLEFER INSTRUMENTS TRADING S.À.R.L · MAILLEFER INSTRUMENTS HOLDING SÀRL · MAILLEFER INSTRUMENTS HOLDING S.A.R.L. · Maillefer Instruments Holding Sarl

Same-named companies — This database also contains companies with near-identical names: Maillefer Instruments S.A., MAILLEFER INSTRUMENTS TRADING S.À.R.L. Company name alone cannot separate their registrations, so the figures below may include either.

FDA 510(k) clearances by year

11996 · K961759

FDA listed device types

showing 8 of 32

Driver, Wire, And Bone Drill, Manual 1Drills, Burrs, Trephines & Accessories (Simple, Powered) 1Fastener, Fixation, Biodegradable, Soft Tissue 1Plate, Bone 1Wire, Surgical 1Mesh, Surgical, Metal 1Plate, Fixation, Bone 1Screw, Fixation, Bone 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K961759	CEMENT AND BONE REMOVAL KIT	1996-06-13
BR	10186370089	BROCA LARGO PEESO	Class II
BR	10186370087	BROCA GATES GLIDDEN	Class II
BR	10186370101	Condensador de Gutta-percha	Class I
SA	ME0000003435SFDAA00183	Rubber Dam Instrument	—
SA	ME0000003435SFDAA00184	Dental Rubber Dam	—

MAILLEFER INSTRUMENTS HOLDING SARL

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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