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Control-X Medical, Inc.

USA · Columbus

✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Brazil, Canada, Singapore, Australia, Israel — 6 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 6Class II 6Class III 0

plus 25 registration records and 10 510(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

6active device licences

Class II 5Class III 1

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

3device registrations

CLASS C 3

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

1active ARTG entries

IIb 1

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 States25 registration records, 10 510(k), 0 PMA, 50 excluded

Brazil2 confirmed, 2 excluded

Saudi Arabia0 confirmed, 1 excluded

Canada6 confirmed, 5 excluded

Manufacturer names merged into this page: Shenzhen SafeSecure Medical Infection Control Tech Co., Ltd · CONTROL MEDICAL TECHNOLOGY · SAFESECURE MEDICAL INFECTION CONTROL PTE. · A & D INSTRUMENTS CANADA, INC. DBA AUTO CONTROL MEDICAL · CONTROL MEDICAL TECHNOLOGY, LLC

FDA 510(k) clearances by year

12004

12010

12012

12013

22020

12022

12024

22025

FDA listed device types

showing 8 of 12

Indicator, Physical/Chemical Sterilization Process 1Wrap, Sterilization 1Drape, Surgical, Exempt 1Syringe, Piston 1Aspiration Thrombectomy Catheter 1Cover, Barrier, Protective 1Sling, Arm, Overhead Supported 1Accessory, Surgical Apparel 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K251991	SafeSecure Steam Sterilization Process Indicator (4012, 4013, 4014, 4016); SafeSecure Vaporized Hydrogen Peroxide Sterilization Process Indicator (4211, 4212, 4213)	2025-12-23
US	K250013	VentiV 7Fr -12Fr MP Mechanical Thrombectomy System (VS7-MP60S, VS7-MP90S, VS8-MP60S, VS8-MP90S, VS8-MP100B, VS10-MP100B, VS11-MP60S, VS11-MP90S, VS12-MP100B, 7F-MP60S, 7F-MP90S, 8F-MP60S, 8F-MP100B, 10F-MP100B, 11F-MP60S, 11F-MP90S, 11P-MP60S, 11P-MP90S, 12F-MP100B, V30-ASP)	2025-03-24
US	K242839	Safe Secure Sterilization Pouches and Rolls	2024-10-16
BR	80065320270	ASPIRE - Sistema de Aspiração	Class II
BR	80065320271	aspire ASPIRATOR	Class II
CA	7029	FEMTENS	Class II
CA	7030	FEMTENS SELF-ADHERING MEDICAL NEUROSTIMULATION ELECTRODES	Class II
CA	70560	ITEST LANCETS/LANCETTES	Class II

Control-X Medical, 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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