AVITA (WUJIANG) CO., LTD

FDA Device Registration & Listing · Wujiang City Jiangsu, CN · Registration 3004727197

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3004727197
FEI Number
3004727197
Entity Name
AVITA (WUJIANG) CO., LTD
City/State/Country
Wujiang City Jiangsu, CN
Establishment Address
No.858.Jiao Tong Road, Wujiang Economic Development Zone, Wujiang City Jiangsu 215200, CN
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
AViTA (WUJIANG) CO., LTD (Owner Number: 9066962)
Owner / Operator Contact Address
No.858.Jiao Tong Road, Wujiang Economic Development Zone, Wujiang City, Jiangsu, CHINA, CN-NOTA 215200, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K242193
PMA Number
N/A

All Registered Proprietary Names

BRAUN Sensian 4 3-in-1 Thermometer BNT100USV2 6NRLI-K Cuff (33–42 cm arm circumference) 6NRMI-K Cuff (22–33 cm arm circumference) 6NRSI-K Cuff (15–22 cm arm circumference) 6NRUI-K Cuff (22–42 cm arm circumference) 6NRXI-K Cuff (2–52 cm arm circumference) Arm Type Blood Pressure Monitor (BPM82)

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 2018-07-31
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2020-05-19
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2012-02-07
DQA Oximeter Cardiovascular Class 2 870.2700 2024-09-12
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2008-01-11
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2011-03-22
DXQ Blood Pressure Cuff Cardiovascular Class 2 870.1120 2026-04-16
MDM Instrument, Manual, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2021-08-23
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2010-03-08
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2008-01-11
DRG Transmitters And Receivers, Physiological Signal, Radiofrequency Cardiovascular Class 2 870.2910 2008-01-11
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2014-06-03
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2020-04-17
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2021-05-06
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2009-12-07
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2012-01-08
IRT Pad, Heating, Powered Physical Medicine Class 2 890.5740 2024-11-08
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2008-01-11
CCQ Nebulizer, Medicinal, Non-Ventilatory (Atomizer) Anesthesiology Class 1 868.5640 2025-12-04
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2020-05-28
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2011-03-02
DQA Oximeter Cardiovascular Class 2 870.2700 2025-03-03
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2017-04-19
BTA Pump, Portable, Aspiration (Manual Or Powered) General, Plastic Surgery Class 2 878.4780 2020-05-28
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2026-04-16

Official Correspondent

Rex Hsieh

US Agent Details

Ken Grant Business: Compliance Engineering, Inc Email: Kgrant@Compliance-Engineer.Com Phone: (516) 9847287

Related Public Records

Same Entity

AViTA (WUJIANG) CO., LTD
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-0032-2025 MEDLINE INDUSTRIES, LP Northfield 2
MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001
Z-0033-2025 MEDLINE INDUSTRIES, LP Northfield 2
MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001U.
Z-0034-2025 MEDLINE INDUSTRIES, LP Northfield 2
MEDLINE Automatic Digital Blood Pressure Monitor, REF MDS1001UT.
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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004727197. Last updated year: 2026. Please use registration number 3004727197 when referencing this establishment in official correspondence.
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