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Innovative Health Sciences, LLC

USA · Chester

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Canada, Israel — 4 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

14listed device types

Class I 0Class II 14Class III 0

plus 42 registration records and 52 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

2registered devices

Class II 2

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

3 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

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 States42 registration records, 52 510(k), 0 PMA, 106 excluded

Brazil2 confirmed, 9 excluded

Saudi Arabia0 confirmed, 4 excluded

Canada0 confirmed, 13 excluded

Manufacturer names merged into this page: INNOVATIVE HEALTH, LLC. · INNOVATIVE HEALTH SCIENCES · INNOVATIVE HEALTH SCIENCES, LLC · INNOVATIVE HEALTH LLC. · INNOVATIVE HEALTH SCIENCES LLC

FDA 510(k) clearances by year

112016

72017

52018

82019

52020

62021

32022

22023

42024

12026

FDA listed device types

showing 8 of 14

Cable, Electrode 1Reprocessed Catheter Introducer 1Catheter, Recording, Electrode, Reprocessed 1Reprocessed Intravascular Ultrasound Catheter 1Catheter, Intracardiac Mapping, High-Density Array 1Catheter, Intracardiac Mapping, High-Density, Reprocessed 1Immunoglobulin G (Igg) Infusion System 1Catheter, Electrode Recording, Or Probe, Electrode Recording 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K250305	Reprocessed Agilis NxT Steerable Introducer	2026-01-07
US	K231015	Reprocessed Super Torque and Super Torque Plus Diagnostic Angiographic Catheters	2024-07-01
US	K233825	Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter	2024-06-07
BR	80299889051	Insignis26G Subcutaneous Needle Set	Class II
BR	80299889078	Insignis26G Subcutaneous Needle Set	Class II

Innovative Health Sciences, LLC

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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