Home›USA›LUCAS MEDICAL, INC (NORTH CASE)

LUCAS MEDICAL, INC (NORTH CASE)

USA

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Saudi Arabia — 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

3listed device types

Class I 0Class II 3Class III 0

plus 16 registration records and 16 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

1registered devices

Class II 1

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

1registered imported devices

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

CACanadaMDALL

0active device licences

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 States16 registration records, 16 510(k), 0 PMA, 3 excluded

Brazil1 confirmed, 0 excluded

Saudi Arabia1 confirmed, 0 excluded

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

FDA 510(k) clearances by year

11997

11999

12000

32003

12008

12010

12011

12012

12017

12018

22022

12024

12026

FDA listed device types

Wrap, Sterilization 1Sterilization Wrap Containers, Trays, Cassettes & Other Accessories 1Indicator, Physical/Chemical Sterilization Process 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K252854	SteriTite Container System with MediTray Products	2026-06-03
US	K240898	SteriTite rigid reusable sterilization container with MediTray Products	2024-07-31
US	K221492	SteriTite Container System with MediTray Parts	2022-10-07
BR	10256400006	CATETER PARA EMBOLECTOMIA LUCAS MEDICAL	Class II
SA	ME0000022028SFDAA00001	Case MR8™ sterilization	—

LUCAS MEDICAL, INC (NORTH CASE)

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

Similar companies