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Mc3 Incorporated

USA · Dexter

✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel — 8 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

10listed device types

Class I 2Class II 8Class III 0

plus 18 registration records and 6 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

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

0active device licences

5 including historic records

TWTaiwanTFDA

2valid device licences

Class II 2

SGSingaporeHSA SMDR

4device registrations

CLASS B 2CLASS C 1CLASS D 1

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

10active ARTG entries

Class I 7Class III 1IIa 1IIb 1

HKHong KongMDACS

2valid listings

Class II 1Class IV 1

ILIsraelAMAR

4registrations

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 States18 registration records, 6 510(k), 0 PMA, 1 excluded

Manufacturer names merged into this page: MC3, Inc. · MC3, INC.

FDA 510(k) clearances by year

12017 · K171610

22018 · K182914

12020 · K191935

12021 · K203409

12023 · K232767

FDA listed device types

showing 8 of 10

Single Lumen Ecmo Cannula 1Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass 1Tubing, Long Term Support Greater Than 6 Hours 1Dual Lumen Ecmo Cannula 1Blood Pump For Ecmo, Long-Term (> 6 Hours) Use 1Extracorporeal System For Long-Term Respiratory / Cardiopulmonary Failure 1Dilator, Vessel, For Percutaneous Catheterization 1Oxygenator, Long Term Support Greater Than 6 Hours 1

Market	Identifier	Name	Class / date
US	K232767	Nautilus VF ECMO Oxygenator	2023-10-04
US	K203409	MC3 Crescent Jugular Dual Lumen Catheter	2021-05-03
US	K191935	Nautilus Smart ECMO Module	2020-04-09

Mc3 Incorporated

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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