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ADEPT MEDICAL LIMITED

New Zealand · Auckland Metro

✓ Record-verifiedregistrations found in 6 markets

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

14listed device types

Class I 13Class II 1Class III 0

plus 14 registration records and 5 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

2registered devices

Class I 2

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

5active device licences

Class II 4Class III 1

TWTaiwanTFDA

2valid device licences

Class I 2

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

33active ARTG entries

Class I 24IIa 6Class Is (sterile) 3

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

4registrations

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 States14 registration records, 5 510(k), 0 PMA, 2 excluded

Brazil2 confirmed, 0 excluded

Saudi Arabia0 confirmed, 1 excluded

Canada5 confirmed, 1 excluded

Manufacturer names merged into this page: ADEPT MEDICAL LTD · ADEPT MEDICAL LIMITED

FDA 510(k) clearances by year

32003 · K032221

12004 · K042496

12006 · K061058

FDA listed device types

showing 8 of 14

Tube, Ear Suction 1Knife, Myringotomy 1Support, Patient Position 1Excavator, Ear 1Kit, Surgical Instrument, Disposable 1Table And Attachments, Operating-Room 1Chair And Table, Medical 1Speculum, Ent 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K061058	NEOZOLINE VENTILATION TUBES	2006-07-12
US	K042496	ADEPT ULTRALITE 532 LASER	2004-11-02
US	K032221	ADEPT 1064/755 LASER	2003-10-24
BR	10212990368	ACESSÓRIOS PARA MESA DE IMAGEM	Class I
BR	10212990369	SUPORTE PARA BRAÇOS SUSPENSO	Class I
CA	72325	SUCTION TUBES WITH CONTROLLERS	Class II
CA	72326	MYRINGOTOMY KNIFE	Class II
CA	72327	MYRINGOTOMY KIT	Class II

ADEPT MEDICAL 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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