ENZTEC LIMITED

New Zealand · Christchurch Canterbury

✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Brazil, Saudi Arabia, Taiwan, Israel, Russia — 6 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

35listed device types

Class I 19Class II 16Class III 0

plus 31 registration records and 5 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

3registered devices

Class I 3

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

2registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

2valid device licences

Class I 2

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

3registrations

RURussiaRoszdravnadzor

1active registrations

Class 2a 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 States31 registration records, 5 510(k), 0 PMA

Brazil3 confirmed, 0 excluded

Saudi Arabia2 confirmed, 0 excluded

Manufacturer names merged into this page: ENZTEC LIMITED · Enztec Limited

FDA 510(k) clearances by year

12021 · K212823

12022 · K220449

32023 · K232014

FDA listed device types

showing 8 of 35

Template 1Rasp 1Hook, Bone 1Clamp 1Impactor 1Guide, Surgical, Instrument 1Instrument, Cutting, Orthopedic 1Screwdriver 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K232014	CONDUIT ATP Inserters	2023-09-01
US	K230876	RI.KNEE Adjustable Tibia Cut Guide	2023-06-27
US	K223671	CONDUIT LLIF Straight Inserters	2023-01-05
BR	81290840038	INSTRUMENTAIS ENZTEC	Class I
BR	80145901982	Instrumentais para Cirurgia de Coluna Enztec	Class I
BR	80145901813	Kit Instrumental para Joelho Enztec	Class I
SA	ME0000003225SFDAA00001	HP Femoral Imp/Ext W/O Handle	—
SA	ME0000003225SFDAA00002	MBT Tibial Impactor	—

ENZTEC LIMITED

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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