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Bracco Diagnostics, Inc.

USA · Monroe Township

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Saudi Arabia, Canada, Singapore — 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

5510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 5 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

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

SASaudi ArabiaSFDA

4registered imported devices

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

CACanadaMDALL

11active device licences

Class II 11

29 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

1device registrations

CLASS C 1

KRSouth KoreaMFDS GMP

pendingnot queried

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 States0 registration records, 5 510(k), 0 PMA, 3 excluded

Brazil0 confirmed, 2 excluded

Saudi Arabia4 confirmed, 0 excluded

Canada11 confirmed, 1 excluded

Manufacturer names merged into this page: E-Z-EM INC, A SUBSIDIARY OF BRACCO DIAGNOSTICS INC. · E-Z-EM INC. A SUBSIDIARY OF BRACCO DIAGNOSTICS A.D.B.A. BRACCO DIAGNOSTICS INC. · E-Z-EM, INC. (A SUBSIDIARY OF BRACCO DIAGNOSTICS INC.) · E-Z-EM, Inc., a subsidiary of Bracco Diagnostics Inc.

Same-named companies — This database also contains companies with near-identical names: E-Z-EM, INC. (A SUBSIDIARY OF BRACCO DIAGNOSTICS INC.), E-Z-EM INC. A SUBSIDIARY OF BRACCO DIAGNOSTICS A.D.B.A. BRACCO DIAGNOSTICS INC., Em Diagnostics, Inc.. Company name alone cannot separate their registrations, so the figures below may include either.

Registration details (sample)

Market	Identifier	Name	Class / date
US	K243881	HeartSee Cardiac P.E.T. Processing Software For Myocardial Perfusion and Coronary Flow Reserve (CFR) Version 4	2025-03-03
US	K181343	HeartSee Cardiac P.E.T. Processing Software	2018-06-12
US	K132192	BRACCO DIAGNOSTICS INC. PROTOCO, L TOUCH COLON INSUFFLATOR	2014-02-14
SA	ME0000007065SFDAA00001	Vented Cap for Waste Bottle	—
SA	ME0000007065SFDAA00002	Waste Bottle	—
CA	32684	MRI BIO-GUN	Class II
CA	86977	CO2 ENDOSCOPIC INSUFFLATOR WATER BOTTLE HOLDER	Class II
CA	21788	MRI COMPATIBLE BIOPSY NEEDLE	Class II

Bracco Diagnostics, Inc.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

Registration details (sample)

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