Home›Taiwan›AVITA CORPORATION

AVITA CORPORATION

Taiwan · New Taipei City

✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Canada, Singapore, Australia, Hong Kong, Israel — 7 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

pendingnot queried

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

10listed device types

Class I 2Class II 8Class III 0

plus 20 registration records and 27 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

9registered devices

Class II 9

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

6active device licences

Class II 6

16 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

1device registrations

CLASS B 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

4active ARTG entries

IIa 4

HKHong KongMDACS

2valid listings

Class II 2

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 States20 registration records, 27 510(k), 0 PMA, 4 excluded

Brazil9 confirmed, 2 excluded

Canada6 confirmed, 1 excluded

Manufacturer names merged into this page: AVITA CORPORATION

FDA 510(k) clearances by year

12000

22001

32003

12004

12007

12008

22009

32010

12011

22012

22018

12020

32024

22025

22026

FDA listed device types

showing 8 of 10

System, Measurement, Blood-Pressure, Non-Invasive 1Bottle, Collection, Vacuum 1Breast Pump Kit 1Humidifier Nebulizer Kit 1Oximeter, Infrared, Sporting, Aviation 1Oximeter 1Continuous Measurement Thermometer 1Pump, Portable, Aspiration (Manual Or Powered) 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K250129	AViTA Breast Pump	2026-06-11
US	K252448	AViTA Pulse Oximeter (SP61)	2026-02-27
US	K250765	AViTA Arm Type Blood Pressure Monitor Cuff	2025-09-03
BR	10343209047	INALADOR / NEBULIZADOR COMPRESSOR PORTÁTIL INCOTERM NB700	Class II
BR	81602809007	MONITOR DE PRESSÃO ARTERIAL DE PULSO	Class II
BR	10343209052	ASPIRADOR NASAL ELÉTRICO	Class II
CA	60878	FAT GENIUS BODY FAT ANALYZER	Class II
CA	64316	VITALIO BODY FAT ANALYZER (BF 101/102)	Class II
CA	64317	BLOOD PRESSURE MONITORS	Class II

AVITA CORPORATION

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

Similar companies