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Elite Surgical Supplies (Pty), Ltd.

South Africa · Pretoria Gauteng

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Israel — 2 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

13listed device types

Class I 6Class II 7Class III 0

plus 10 registration records and 4 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

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

TWTaiwanTFDA

pendingnot queried

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 States10 registration records, 4 510(k), 0 PMA, 22 excluded

Brazil0 confirmed, 2 excluded

Saudi Arabia0 confirmed, 5 excluded

Manufacturer names merged into this page: ELITE SURGICAL SUPPLIES (PTY) LTD

FDA 510(k) clearances by year

12007 · K063453

12008 · K080075

12013 · K130274

12020 · K200523

FDA listed device types

showing 8 of 13

Template 1Instrument, Surgical, Disposable 1Kit, Surgical Instrument, Disposable 1Caliper 1Tape, Measuring, Rulers And Calipers 1Tray, Surgical, Instrument 1Appliance, Fixation, Spinal Intervertebral Body 1Intervertebral Fusion Device With Bone Graft, Lumbar 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K200523	Biolign® Roto-Loc Cervical Plate System	2020-04-30
US	K130274	BIOLIGN ACIF SYSTEMS, BIOLIGN STACC ACIF SYSTEM, BIOLIGN TLIF SYSTEM	2013-10-29
US	K080075	MODIFICATION TO: VERTEFIX PEDICLE SCREW SPINAL SYSTEM	2008-01-28

Elite Surgical Supplies (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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