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CenterPoint Systems, LLC

USA · West Valley

✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel — 9 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 10Class III 0

plus 18 registration records and 17 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

1registered devices

Class I 1

3 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

4 including historic records

TWTaiwanTFDA

2valid device licences

Class II 2

SGSingaporeHSA SMDR

2device registrations

CLASS D 2

KRSouth KoreaMFDS GMP

5GMP quality-system certificates

Import 5

AUAustraliaTGA ARTG

4active ARTG entries

Class III 3Class Is (sterile) 1

HKHong KongMDACS

1valid listings

Class IV 1

ILIsraelAMAR

3registrations

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 States18 registration records, 17 510(k), 0 PMA

Brazil1 confirmed, 0 excluded

Manufacturer names merged into this page: CENTERPOINT SYSTEMS LLC

FDA 510(k) clearances by year

12019

12021

22023

42024

42025 · K250147

52026 · K262240

FDA listed device types

showing 8 of 12

Forceps, Biopsy, Non-Electric 1Instruments, Surgical, Cardiovascular 1Endoscope Channel Accessory 1Bronchoscope (Flexible Or Rigid) 1Endoscopic Video Imaging System/Component, Gastroenterology-Urology 1Catheter, Steerable 1Choledochoscope And Accessories, Flexible/Rigid 1Led Light Source 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K262240	SSPC NXT Delivery Catheter	2026-07-29
US	K261766	CPS Locator 3D Plus Delivery Catheter	2026-07-29
US	K261492	FieldFlex Steerable Sheath	2026-06-05
BR	10341351054	Ferramenta de Travamento Helix	Class I

CenterPoint Systems, 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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