FDA.reportPublic FDA data

Avita Medical Americas LLC

Matched from indexed company URL: AVITA CORPORATION

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
20294123001452123Avita Medical Americas LLC1N2026-01-013007 Bunsen Ave UNIT K Ventura CA US 93003
96175433003272793AVITA CORPORATION1N2026-01-019F, NO. 78, SEC. 1, Kwang-Fu Road San-Chung District, New Taipei City TW 24158
30142707953014270795AVITA MEDICAL AMERICAS LLC1N2026-01-0128159 Avenue Stanford Suite 220 Valencia CA US 91355

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
04710953421628Harbor Freight Tools - The product automatically measures human begins Systolic, Diastolic blood pressure and pulse rate by oscillometric method. The measurement results are displayed on the LCD. Measurement position is at human being's wrist. The intended use of this over-the-counter device is for adults with wrist circumference ranging from 125 mm to 210 mm (Approx.4.9 ~ 8.3 inches) and for home use. When the device detects the appearance of irregular heartbeats such as atrial or ventricular premature beats during measurement, an indicated symbol will appear with measuring readings. This device is designed only for adults.+886285121568pin_fan@avita.com.tw
04710953421635Harbor Freight Tools - The product automatically measures human begins Systolic, Diastolic blood pressure and pulse rate by oscillometric method. The measurement results are displayed on the LCD. Measurement position is at human being's wrist. The intended use of this over-the-counter device is for adults with wrist circumference ranging from 125 mm to 210 mm (Approx.4.9 ~ 8.3 inches) and for home use. When the device detects the appearance of irregular heartbeats such as atrial or ventricular premature beats during measurement, an indicated symbol will appear with measuring readings. This device is designed only for adults.+886285121568pin_fan@avita.com.tw

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
578871719415052K242455AViTA Pulse Oximeter (SP62B)DQA2025-02-19
578871462569617K242193Arm Type Blood Pressure Monitor (BPM82)DXN2024-10-22
578871930594339K241852Nasal Aspirator (NS 13)BTA2024-12-31
578871683195631K223399AViTA Pulse OximeterDQA2024-05-20
578871631515875K181242Braun BNT400 No Touch + Forehead ThermometerFLL2018-07-23
578871313955203K181015Braun BFH175 Infrared Forehead ThermometerFLL2018-07-18
578871193041808K180155Arm Type Blood Pressure MonitorDXN2018-08-03
578871508429146K172427AViTA Radar Thermo NT16 Series IR ThermometerFLL2018-04-19
578871098835554K163516Braun No Touch + Forehead NTF3000 ThermometerFLL2017-04-21
578871745855507K120672KD-936 FULLY AUTOMATIC WIRELESS BLOOD PRESSURE MONITORDXN2012-06-01
578871361489103K110559AVITA INFRARED THEROMETER WITH BLUETOOTHFLL2012-01-06
578871106639594K102554AVITA SCANEO IR THERMOMETER MODEL TS4X SERIESFLL2011-03-03
578871328454328K090379AVITA NASAL ASPIRATOR, MODEL, NS1 SERIESBTA2010-05-26
578871283100352K081160AVITA RADAR THERMO IR THERMOMETER, NT1 SERIESFLL2008-06-24
578871025045558K002182AVITA TSO/TS1 INFRARED EAR THERMOMETERFLL2000-12-29
2233291589829432BP220799
2233261589829432BP220799
2233291512362847BP170122
2233261512362847BP170122
2233291322634199
578871332698526
578871446328393
578871553034095
578871627335768
578871829364726
578871951234157

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
FLL92018-07-23
DXN32024-10-22
DQA22025-02-19
BTA22024-12-31

PMN#

GUDID#