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Southern Implants (Pty), Ltd.

South Africa · Irene

✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, Australia, Hong Kong, Israel, Russia — 9 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

18listed device types

Class I 6Class II 12Class III 0

plus 41 registration records and 30 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

4registered devices

Class I 3Class II 1

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

20 including historic records

TWTaiwanTFDA

7valid device licences

Class I 2Class II 1Class III 4

SGSingaporeHSA SMDR

4device registrations

CLASS C 4

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

52active ARTG entries

Class I 24IIa 14IIb 12Class Is (sterile) 2

HKHong KongMDACS

1valid listings

Class III 1

ILIsraelAMAR

3registrations

RURussiaRoszdravnadzor

4active registrations

Class 2a 1Class 2b 2Class 3 1

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 States41 registration records, 30 510(k), 0 PMA, 14 excluded

Brazil4 confirmed, 2 excluded

Canada0 confirmed, 2 excluded

Manufacturer names merged into this page: SOUTHERN IMPLANTS (PTY) LTD · SOUTHERN MEDICAL (PTY) LTD · SOUTHERN IMPLANTS PTY LTD.

FDA 510(k) clearances by year

32007

12008

12010

12016

22017

52018

22019

22020

42022

72023

12024

12025

FDA listed device types

showing 8 of 18

Plate, Bone 1Screw, Fixation, Intraosseous 1Appliance, Fixation, Spinal Intervertebral Body 1Dental Abutment Design Software For Dental Laboratory 1Intervertebral Fusion Device With Bone Graft, Lumbar 1Sterilization Wrap Containers, Trays, Cassettes & Other Accessories 1Abutment, Implant, Dental, Endosseous 1Intervertebral Fusion Device With Bone Graft, Cervical 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K253373	Southern Craniomaxillofacial (CMF) System	2025-12-19
US	K232726	External Hex Implant System	2024-04-01
US	K232418	Single Platform SP1 Implant System	2023-12-01
BR	10344420494	INSTRUMENTAIS DE INSERÇÃO EM AÇO INOXIDÁVEL PARA IMPLANTES ZIGOMÁTICOS	Class I
BR	10344429056	INSTRUMENTAIS CIRÚRGICOS EM TI PARA IMPLANTES ZIGOMÁTICOS	Class II
BR	10344420495	INSTRUMENTAIS CIRÚRGICOS EM AÇO INOXIDÁVEL PARA IMPLANTES ZIGOMÁTICOS	Class I

Southern Implants (Pty), Ltd.

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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