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LUCAS MEDICAL, INC.

USA · Orange

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Singapore, Australia, Israel — 5 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

4listed device types

Class I 1Class II 3Class III 0

plus 7 registration records and 7 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

1registered devices

Class II 1

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

0valid device licences

SGSingaporeHSA SMDR

1device registrations

CLASS B 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

1active ARTG entries

IIa 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 States7 registration records, 7 510(k), 0 PMA, 11 excluded

Brazil1 confirmed, 1 excluded

Manufacturer names merged into this page: LUCAS MEDICAL, INC. · LUCAS MEDICAL, INC (NORTH CASE)

FDA 510(k) clearances by year

41996 · K955126

21997 · K972623

11999 · K983802

FDA listed device types

Stents, Drains And Dilators For The Biliary Ducts 1Catheter, Intravascular Occluding, Temporary 1Catheter, Embolectomy 1Catheter, Irrigation 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K983802	LMI CAROTID ENDARTERECTOMY SHUNT CATHETER, MODEL #'S CES, CESR, CESB, CESRB, CEST, CESTR, CESTB, CESTRB, CES-SB, CESR-SB	1999-07-30
US	K972623	LMI IRRIGATION CATHETER (IGR)	1997-11-19
US	K970657	LMI THROMBECTOMY CATHETER	1997-07-01
BR	10256400006	CATETER PARA EMBOLECTOMIA LUCAS MEDICAL	Class II

LUCAS MEDICAL, 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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