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Mortara Instrument, Inc.

USA · Milwaukee

✓ Record-verifiedregistrations found in 4 markets

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

51510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 51 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

3registered devices

Class II 3

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 7

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

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, 51 510(k), 0 PMA

Brazil3 confirmed, 0 excluded

Canada7 confirmed, 0 excluded

Manufacturer names merged into this page: MORTARA INSTRUMENT INC. · MORTARA INSTRUMENT, INC

Registration details (sample)

Market	Identifier	Name	Class / date
US	K182297	Surveyor S2	2019-01-24
US	K173765	Surveyor Patient Monitor	2018-09-04
US	K161517	Mortara Surveyor Patient Monitor	2017-01-11
BR	80288099012	GRAVADOR DE HOLTER DIGITAL MORTARA	Class II
BR	80288099015	ELETROCARDIÓGRAFO DE 12 DERIVAÇÕES EM REPOUSO	Class II
BR	80288099013	AMBULO 2400	Class II
CA	6700	ECLIPSE ELECTROCARDIOGRAPH	Class II
CA	63575	ELI 100 ELECTROCARDIOGRAPH	Class II
CA	63576	ELI 200 ELECTROCARDIOGRAPH	Class II

Mortara Instrument, Inc.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

Registration details (sample)

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