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SOUTHMEDIC, INC.

Canada · Barrie

✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, South Korea, Australia, Israel — 8 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

27listed device types

Class I 17Class II 8Class III 0unclassified 2

plus 35 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

1registered imported devices

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

CACanadaMDALL

12active device licences

Class II 12

45 including historic records

TWTaiwanTFDA

2valid device licences

Class I 2

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

6active ARTG entries

Class I 1IIa 5

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

2registrations

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 States35 registration records, 10 510(k), 0 PMA

Brazil2 confirmed, 0 excluded

Saudi Arabia1 confirmed, 0 excluded

Canada12 confirmed, 0 excluded

Manufacturer names merged into this page: SOUTHMEDIC, INC. · SOUTHMEDIC INC. · Southmedic Inc.

FDA 510(k) clearances by year

11984

31986

11993

11995

12002

12011

12014

12023

FDA listed device types

showing 8 of 27

Accessories, Cleaning Brushes, For Endoscope 1Stylet, Tracheal Tube 1Device, Specimen Collection 1Support, Patient Position 1Topical Approximation System 1Laryngoscope, Rigid 1Endoscopic Bite Block 1Brush, Scrub, Operating-Room 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K222511	Oxy2Pro	2023-11-21
US	K131410	CO2/O2 NASAL CANNULA (WITH 4 (10CM) O2 AND CO2 TUBE), CO2/O2 NASAL CANNULA (WITH 8 (240CM) O2 AND 4 (10CM) CO2 TUBE),	2014-01-13
US	K101953	SMDIA-1000	2011-01-07
BR	81832589105	OxyMask	Class II
BR	81832589107	OxyMask O2 Aerosol	Class II
SA	ME0000007861SFDAA00017	BETTERSHIELD	—
CA	6950	SURGICAL BLADES	Class II
CA	62142	PVC TUBING	Class II
CA	71099	VAPOFIL KEYED ANAESTHETIC AGENT ADAPTER WITH PVC SLEEVE	Class II

SOUTHMEDIC, 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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