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Medical Cv, Inc.

USA · Inver Grove Heights

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Canada — 3 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

84listed device types

Class I 35Class II 46Class III 2unclassified 1

plus 205 registration records and 7 510(k), 8 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

7registered devices

Class I 3Class II 4

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

1active device licences

Class IV 1

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

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 States205 registration records, 7 510(k), 8 PMA, 47 excluded

Brazil7 confirmed, 16 excluded

Saudi Arabia0 confirmed, 7 excluded

Canada1 confirmed, 0 excluded

Manufacturer names merged into this page: MARTECH MEDICAL PRODUCTS S. DE RL. DE CV. · Devicor Medical Products de Mexico S de RL de CV · HARMAC MEDICAL PRODUCTS, INC./H3 de Tijuana, S. de RL de CV · Sunrise Medical Tecnologias, S.A. de CV · MEDICALCV INC. · SMITHS HEALTHCARE MANUFACTURING SA DE CV -MÉXICO PARA SMITHS MEDICAL INTERNATIONAL LTD.

FDA 510(k) clearances by year

22004 · K040744

12005 · K052495

12006 · K060680

12007 · K061489

12008 · K081457

12024 · K233974

FDA listed device types

showing 8 of 84

Fluorometer, Lead (Dedicated Instruments) 1Cystoscope And Accessories, Flexible/Rigid 1Catheter, Hemodialysis, Non-Implanted 1Accessories, A-V Shunt 1Kit, Repair, Catheter, Hemodialysis 1Port & Catheter, Implanted, Subcutaneous, Intravascular 1System, Suction, Lipoplasty For Removal 1Injector And Syringe, Angiographic 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K233974	Mucosal Impedance Measurement System	2024-09-06
US	K081457	ATRILAZE LASER ABLATION SYSTEM	2008-08-08
US	K061489	ATRILAZE MI SURGICAL ABLATION SYSTEM	2007-03-16
BR	10150470189	MASCARA PARA TERAPIA RESPIRATORIA PORTEX / SMITHS MEDICAL	Class II
BR	10224000063	Gypsona BSN	Class I
BR	80269330004	SONDAS MAMMOTOME RM PARA BIÓPSIA	Class II
CA	60649	OMNICARDON CARDIAC VALVE PROSTHESIS, AORTIC AND MITRAL	Class IV

Medical Cv, Inc.

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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