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Medical Components, Inc.

USA · Harleysville

✓ 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

73listed device types

Class I 12Class II 56Class III 4unclassified 1

plus 279 registration records and 94 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

5registered devices

Class I 2Class II 3

29 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

13active device licences

Class II 10Class III 3

80 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 States279 registration records, 94 510(k), 0 PMA, 26 excluded

Brazil5 confirmed, 1 excluded

Canada13 confirmed, 1 excluded

Manufacturer names merged into this page: MEDICAL COMPONENTS INC · ARCH MEDICAL SOLUTIONS - PHILADELPHIA, LLC DBA JADE PRECISION MEDICAL COMPONENTS · Medical Components, Inc. · Heraeus Medical Components Caribe, Inc. · MEDICAL COMPONENTS, INC. · HERAEUS MEDICAL COMPONENTS, LLC

FDA 510(k) clearances by year

11995

11996

31998

51999

52001

12002

12009

22011

82012

82013

42014

12015

22016

102017

32018

32019

22020

12021

12023

12025

FDA listed device types

showing 8 of 73

Posterior Cervical Screw System 1Intervertebral Fusion Device With Bone Graft, Thoracic 1Catheter, Hemodialysis, Non-Implanted 1Thoracolumbosacral Pedicle Screw System 1Appliance, Fixation, Spinal Intervertebral Body 1Endoscopic Guidewire, Gastroenterology-Urology 1Accessories, A-V Shunt 1Kit, Repair, Catheter, Hemodialysis 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K250836	14F Duo-Flow® Side X Side Double Lumen Catheter	2025-08-12
US	K232945	Trio-CT® Triple Lumen Catheter w/ Curved Extensions	2023-11-16
US	K210461	End Cap	2021-09-14
BR	80689090156	Fio Guia Híbrido SOLO PLUS	Class II
BR	10312210044	INTRODUTOR VALVULADO PARA CATETER DE HEMODIÁLISE E AFÉRESE	Class II
BR	10312210045	KIT REPARADOR PARA CATETER DE HEMODIÁLISE E AFÉRESE	Class I
CA	13066	DOUBLE LUMEN CVVII CATHETER KIT - SILICONE	Class II
CA	13067	CVVH CATHETER KIT - POLYURETHANE	Class II
CA	4255	VESSEL DILATORS	Class II

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)

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