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BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. S.A. de C.V.

Mexico · Nogales Sonora

✓ Record-verifiedregistrations found in 4 markets

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

15listed device types

Class I 2Class II 13Class III 0

plus 58 registration records and 38 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

8registered devices

Class II 8

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

25active device licences

Class II 23Class III 2

57 including historic records

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

3GMP quality-system certificates

Import 3

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 States58 registration records, 38 510(k), 0 PMA, 14 excluded

Brazil8 confirmed, 0 excluded

Canada25 confirmed, 2 excluded

Manufacturer names merged into this page: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. S.A. de C.V. · BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. · BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC · BECTON DICKINSON INFUSION THERAPY SYSTEMS INC

Same-named companies — This database also contains companies with near-identical names: Becton Dickinson Infusion Therapy Systems, Inc., Infusion Systems Corp.. Company name alone cannot separate their registrations, so the figures below may include either.

FDA 510(k) clearances by year

11988

41997

11998

22000

22001

32002

22004

12005

12010

12011

12013

22015

12016

12017

12019

22020

12022

32023

62025

12026

FDA listed device types

showing 8 of 15

Stopcock, I.V. Set 1Anesthesia Conduction Kit 1Syringe, Piston 1Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days 1Pump, Infusion 1Syringe, Antistick 1Set, I.V. Fluid Transfer 1I.V. Start Kit 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K252137	BD Insyte IV Catheter	2026-04-02
US	K251422	BD Saf-T-Intima Subcutaneous Catheter System	2025-10-08
US	K243403	BD Nexiva Closed IV Catheter System	2025-07-25
BR	10033430186	BD Insyte Autoguard	Class II
BR	10033439112	BD Saf-T-Intima Safety System	Class II
BR	10033439113	BD Saf-T-Intima Safety System	Class II
CA	5863	I.V. LOOP	Class II
CA	5892	MINICATH WINGED NEEDLES WITH PRN	Class II
CA	5910	INTRACATH I.V. CATHETER/NEEDLE UNIT	Class II

BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. S.A. de C.V.

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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