Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9617543

FEI Number

3003272793

Entity Name

AVITA CORPORATION

City/State/Country

San-Chung District, New Taipei City, TW

Establishment Address

9F, NO. 78, SEC. 1,, Kwang-Fu Road, San-Chung District, New Taipei City 24158, TW

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

AViTA CORPORATION (Owner Number: 9042237)

Owner / Operator Contact Address

9F, No. 78, Sec. 1,, Kwang-Fu Road, San-Chung District, New Taipei City, TW-NOTA 24158, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K120672

PMA Number

N/A

All Registered Proprietary Names

Baby 2-in-1 Nasal Aspirator with Sprayer (NS 13) NS22 Nasal Aspirator NS13 AViTA Breast Pump BR10 NS22 AViTA NE 10 AViTA NE 60 AViTA NE 20

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2011-03-22
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2020-09-25
BTA	Pump, Portable, Aspiration (Manual Or Powered)	General, Plastic Surgery	Class 2	878.4780	2025-04-07
OGG	Humidifier Nebulizer Kit	Anesthesiology	Class 2	868.5450	2023-12-22
OHH	Breast Pump Kit	Obstetrics/Gynecology	Class 2	884.5160	2023-07-28
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2012-01-09
KMA	Irrigator, Powered Nasal	Ear, Nose, Throat	Class 1	874.5550	2005-09-02
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2008-07-02
OCH	Oximeter, Infrared, Sporting, Aviation	Cardiovascular	Class 2	870.2700	2023-06-28
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2020-09-11
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2024-06-28
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2020-09-13
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2018-09-25
CCQ	Nebulizer, Medicinal, Non-Ventilatory (Atomizer)	Anesthesiology	Class 1	868.5640	2026-01-15
KDQ	Bottle, Collection, Vacuum	General Hospital	Class 2	880.6740	2013-07-03
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2018-05-03
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2017-04-19

Official Correspondent

Rex Hsieh

US Agent Details

Matt Dryden Business: ProMedic, LLC. Email: matt.dryden@promedic.cc Phone: (239) 3076063

Related Public Records

Same Entity

AViTA CORPORATION

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K010462	Avita Corporation	AVITA PICCOLO/EXATO INFARED EAR THERMOMETER (TS2 & TS4 SERIES)	2001-04-11
K760421	Arbrook Mfg. Corp.	THERMOMETER, SURVALENT-ELECTRONIC	1976-08-23
K813409	Yellow Springs Instrument Co., Inc.	MODEL 2100 DUAL-DISPLAY TELE-THERMOMETER	1981-12-18
K830039	Science Development Corp.	SDC RECTAL TEMP. PROBE PRODUCT #1020	1983-02-23
K842199	Sharp Electronics Corp.	ELEC. DIGITAL THERMOMETER MT-20 & 30	1984-07-18

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0035-2007	Haemonetics Corporation	2	SmartSuction Harmony Powered Suction Device Model Number: HAR-E-115-US
Z-0020-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20 (US) N, Part Number CS08651
Z-0022-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-02
Z-0023-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-03
Z-0028-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	Capnostream20 (US) M, Part Number CS08653

Similar Registrations

Registration Number	Establishment Name	Location
1062836	DIGICARE BIOMEDICAL TECHNOLOGY, INC.	BOYNTON BEACH, FL, US
3009487317	SHENZHEN JUZHONG TECHNOLOGY CO.,LTD	shenzhen Guangdong, CN
9681837	ME CENTER OF TERUMO CORP.	FUJINOMIYA Shizuoka, JP
3038761440	Corsano Health SA	Plan-les-Ouates Geneve, CH
3016595211	DYNAMIC EMS LTD	Dalgety Bay Fife, GB

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9617543. Last updated year: 2026. Please use registration number 9617543 when referencing this establishment in official correspondence.