ONFU electronics Co., LTD.

FDA Device Registration & Listing · Trang Bom Dong Nai, VN · Registration 3016867013

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
3016867013
FEI Number
3016867013
Entity Name
ONFU electronics Co., LTD.
City/State/Country
Trang Bom Dong Nai, VN
Establishment Address
Street No.3, Song May Industrial Zone, Binh Minh Commune,, Trang Bom Dong Nai 76000, VN
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
MICROLIFE CORP. (Owner Number: 8020605)
Owner / Operator Contact Address
9F, 431, RuiGuang Road, NeiHu, TAIPEI, TW-TPE 11492, TW
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K230075
PMA Number
N/A

All Registered Proprietary Names

Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MW1-4B

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 2008-09-17
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2023-03-29
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2023-10-29
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2015-08-05
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2016-02-14
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2008-09-12
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2011-07-20
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2023-06-05
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2007-12-05
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2025-08-21
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2017-08-31
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2009-06-11
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2023-07-12

Official Correspondent

No official correspondent registered.

US Agent Details

Alan Schwartz Business: mdi Consultants Inc. Email: info@mdiconsultants.com Phone: (516) 4829001

Related Public Records

Same Entity

MICROLIFE CORP.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3003993690 MICROLIFE INTELLECTUAL PROPERTY GMBH Widnau Sankt Gallen, CH
8020605 MICROLIFE CORP. TAIPEI, TW
9680225 ONBO ELECTRONIC (SHENZHEN) CO. LTD. SHENZHEN Guangdong, CN

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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016867013. Last updated year: 2026. Please use registration number 3016867013 when referencing this establishment in official correspondence.
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