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GENTUITY, LLC

USA · Sudbury

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Singapore, Australia, 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

3listed device types

Class I 0Class II 3Class III 0

plus 4 registration records and 4 510(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

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

1device registrations

CLASS D 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

2active ARTG entries

Class III 1IIb 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

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 States4 registration records, 4 510(k), 0 PMA

Manufacturer names merged into this page: GENTUITY, LLC

FDA 510(k) clearances by year

12020 · K192922

12023 · K230620

12024 · K242239

12025 · K242966

FDA listed device types

Catheter, Intravascular, Diagnostic 1System, Imaging, Optical Coherence Tomography (Oct) 1Optical Coherence Tomography, Intravascular Catheter 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K242966	Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging Catheter	2025-01-31
US	K242239	HF-OCT Imaging System with Vis-RX Micro-Imaging Catheter (G10 (HF-OCT Console), G30 (Vis-Rx Micro-Imaging Catheter))	2024-08-16
US	K230620	Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging Catheter	2023-08-08

GENTUITY, LLC

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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