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TERUMO CARDIOVASCULAR COSTA RICA, LLC

Costa Rica · Cartago

✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Israel, Russia — 6 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

208listed device types

Class I 35Class II 146Class III 18unclassified 9

plus 682 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

6registered devices

Class II 6

7 including historic records

SASaudi ArabiaSFDA

3registered imported devices

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

CACanadaMDALL

2active device licences

Class II 2

6 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

RURussiaRoszdravnadzor

1active registrations

Class 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 States682 registration records, 0 510(k), 0 PMA

Brazil6 confirmed, 0 excluded

Saudi Arabia3 confirmed, 0 excluded

Canada2 confirmed, 0 excluded

Manufacturer names merged into this page: Viant Costa Rica, S.A. · Nitinol Devices & Components Costa Rica, S. R. L. · Medtronic Medical Costa Rica S.R.L. · Sterigenics Costa Rica S.R.L. · ABBOTT MEDICAL COSTA RICA LTD · TERUMO CARDIOVASCULAR COSTA RICA, LLC

Same-named companies — This database also contains companies with near-identical names: Abbott Medical Costa Rica Ltda., BOSTON SCIENTIFIC DE COSTA RICA S.R.L., Cardinal Health Costa Rica, S.A., Medtronic Medical Costa Rica S.R.L.. Company name alone cannot separate their registrations, so the figures below may include either.

FDA listed device types

showing 8 of 208

Electrosurgical, Cutting & Coagulation & Accessories 1Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component 1Thoracolumbosacral Pedicle Screw System 1Appliance, Fixation, Spinal Intervertebral Body 1Endoscopic Access Overtube, Gastroenterology-Urology 1Catheter, Intracardiac Mapping, High-Density Array 1Valvulotome 1Dialysis Administration Kit 1

Registration details (sample)

Market	Identifier	Name	Class / date
BR	10332349017	EnSite Precision Surface Electrode Kit	Class II
BR	10332349008	EnSite NavX Precision	Class II
BR	10332349014	EnSite X EP System Surface Electrode Kit	Class II
SA	ME0000001070SFDAA00003	Ensite Velocity Surface Electrode Kit	—
SA	ME0000001070SFDAA00005	EnSite X EP System Surface Electrode Kit	—
CA	61991	ENSITE NAVX SURFACE ELECTRODE KITS	Class II
CA	97747	ENSITE VELOCITY SURFACE ELECTRODE KIT	Class II

TERUMO CARDIOVASCULAR COSTA RICA, LLC

Registrations by market

How these numbers were verified

Company information

FDA listed device types

Registration details (sample)

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