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Salter Labs de Mexico de S.A. de C.V.

Mexico · Chihuahua Mexico

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Canada, Taiwan — 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

37listed device types

Class I 17Class II 20Class III 0

plus 115 registration records and 50 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

39registered devices

Class I 20Class II 19

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

3active device licences

Class II 3

6 including historic records

TWTaiwanTFDA

7valid device licences

Class I 7

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

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 States115 registration records, 50 510(k), 0 PMA, 3 excluded

Brazil39 confirmed, 1 excluded

Canada3 confirmed, 1 excluded

Manufacturer names merged into this page: Salter Labs · Salter Labs de Mexico de S.A. de C.V. · SALTER LABS · SALTER LABS DE MEXICO S.A. DE C.V.

FDA 510(k) clearances by year

11978

11984

81986

71987

31988

51989

11990

41991

31996

11998

31999

12000

12002

22005

12009

22015

32016

12017

12020

12026

FDA listed device types

showing 8 of 37

Spirometer, Therapeutic (Incentive) 1Nebulizer (Direct Patient Interface) 1Analyzer, Gas, Oxygen, Gaseous-Phase 1Ventilator, Continuous, Facility Use 1Meter, Peak Flow, Spirometry 1Blanket, Neonatal Phototherapy 1Ventilator, Continuous, Non-Life-Supporting 1Blood Pressure Cuff 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K261389	PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1)	2026-07-30
US	K190878	Trach- Vac Endotracheal Tube (SFTVPU) Subglottic Suction Tube with Salter Flex-Tip and Salter ThinCuff, Trach- Vac Endotracheal Tube (SFTVVC) Subglottic Suction Tube with Salter Flex-Tip and Salter ThinCuff	2020-01-10
US	K161719	Salter Labs Bubble Humidifier	2017-09-21
BR	10289680144	Bolsa infusora de pressão INFUSE IT	Class I
BR	10349590031	CÂNULA SALTER LABS	Class II
BR	10320090020	CANULA DE AMOSTRAGEM DE ETCO2 SALTER LABS	Class II
CA	6906	DISPOSABLE SPIROMETER	Class II
CA	33149	INLINE WATER TRAP	Class II
CA	35780	DOSIMETER - AEROSOL GENERATING DEVICE	Class II

Salter Labs de Mexico de 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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