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SOUTHWEST TECHNOLOGIES, INC.

USA · North Kansas City

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Israel — 5 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

7listed device types

Class I 5Class II 0Class III 0unclassified 2

plus 7 registration records and 5 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

4registered devices

Class I 4

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

2 including historic records

TWTaiwanTFDA

1valid device licences

Class I 1

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 States7 registration records, 5 510(k), 0 PMA, 5 excluded

Brazil4 confirmed, 0 excluded

Manufacturer names merged into this page: SOUTHWEST TECHNOLOGIES, INC. · SOUTHWEST TECHNOLOGIES INC.

FDA 510(k) clearances by year

21987 · K872488

12004 · K030774

12009 · K083334

12010 · K102478

FDA listed device types

Exerciser, Non-Measuring 1Protector, Skin Pressure 1Nursing Pad, Cohesive Gel 1Pack, Hot Or Cold, Reusable 1Tips And Pads, Cane, Crutch And Walker 1Dressing, Wound, Drug 1Wound Dressing With Animal-Derived Material(S) 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K102478	OTC ELASTO-GEL MANUKA HONEY WOUND DRESSING	2010-11-03
US	K083334	ELASTO-GEL MANUKA HONEY WOUND DRESSING	2009-07-30
US	K030774	STIMULEN COLLAGEN	2004-08-09
BR	10315999016	LUVA PARA TERAPIA HIPOTÉRMICA ELASTO-GEL	Class I
BR	10315999017	SAPATILHA PARA TERAPIA HIPOTÉRMICA ELASTO-GEL	Class I
BR	10315999015	ELASTO-GEL CAPACETE PARA TERAPIA HIPOTÉRMICA	Class I

SOUTHWEST TECHNOLOGIES, 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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