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HEALTH LINE INTERNATIONAL CORPORATION

USA · Salt Lake City

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Canada, South Korea, 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

12listed device types

Class I 2Class II 9Class III 0unclassified 1

plus 17 registration records and 14 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

1registered devices

Class II 1

8 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

2active device licences

Class II 1Class III 1

3 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

7registrations

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 States17 registration records, 14 510(k), 0 PMA, 27 excluded

Brazil1 confirmed, 12 excluded

Saudi Arabia0 confirmed, 2 excluded

Canada2 confirmed, 3 excluded

Manufacturer names merged into this page: HEALTH LINE INTERNATIONAL CORPORATION

FDA 510(k) clearances by year

12006

12007

12010

22012

12013

22014

12016

12019

22020

12023

12026

FDA listed device types

showing 8 of 12

Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days 1Catheter, Hemodialysis, Non-Implanted 1Wire, Guide, Catheter 1Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days 1Cap, Device Disinfectant 1Set, Administration, Intravascular 1Catheter, Hemodialysis, Triple Lumen, Non-Implanted 1Catheter, Percutaneous 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K261950	Health Line Tearaway Introducer	2026-06-22
US	K222170	Power Acute Triple Lumen Hemodialysis Catheter	2023-01-13
US	K200426	Acute Dual Lumen Hemodialysis Catheter	2020-12-24
BR	80102519406	CATETER HEALTH LINE CT MIDLINE	Class II
CA	85558	IV ADMINISTRATION SET	Class II
CA	92994	PICC KITS	Class III

HEALTH LINE INTERNATIONAL CORPORATION

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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