Home›USA›Advanced Medical Components, Inc.

Advanced Medical Components, Inc.

USA · Lansing

✓ 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

34listed device types

Class I 9Class II 25Class III 0

plus 150 registration records and 64 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

3registered devices

Class I 1Class II 2

5 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

12active device licences

Class II 9Class III 3

73 including historic records

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 States150 registration records, 64 510(k), 0 PMA, 38 excluded

Brazil3 confirmed, 5 excluded

Canada12 confirmed, 2 excluded

Manufacturer names merged into this page: MEDICAL COMPONENTS INC · Medical Components, Inc. · MEDICAL COMPONENTS, INC.

FDA 510(k) clearances by year

21982

41984

71986

11987

11988

31989

11991

21993

11994

11995

11996

31998

51999

52001

12002

12011

82012

52013

22014

12025

FDA listed device types

showing 8 of 34

Catheter, Hemodialysis, Non-Implanted 1Accessories, A-V Shunt 1Kit, Repair, Catheter, Hemodialysis 1Port & Catheter, Implanted, Subcutaneous, Intravascular 1Trocar 1Catheter, Intravascular, Diagnostic 1Clamp, Vascular 1Midline Catheter 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K250836	14F Duo-Flow® Side X Side Double Lumen Catheter	2025-08-12
US	K141633	PRO-PICC WITH VALVE TECHNOLOGY	2014-09-29
US	K132880	MEDCOMP POWER INJECTABLE SAFETY HUBER NEEDLE	2014-01-08
BR	10312210044	INTRODUTOR VALVULADO PARA CATETER DE HEMODIÁLISE E AFÉRESE	Class II
BR	10312210045	KIT REPARADOR PARA CATETER DE HEMODIÁLISE E AFÉRESE	Class I
BR	10312210029	DISPOSITIVO INTRODUTOR MICRO-STICK NITINOL	Class II
CA	13066	DOUBLE LUMEN CVVII CATHETER KIT - SILICONE	Class II
CA	13067	CVVH CATHETER KIT - POLYURETHANE	Class II
CA	4255	VESSEL DILATORS	Class II

Advanced Medical Components, Inc.

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