MICROLIFE CORP.

FDA Device Registration & Listing · TAIPEI, TW · Registration 8020605

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
8020605
FEI Number
3003079707
Entity Name
MICROLIFE CORP.
City/State/Country
TAIPEI, TW
Establishment Address
9F, 431, RuiGuang Road, NeiHu, TAIPEI 11492, TW
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
K112845
PMA Number
N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2013-06-13
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2017-11-16
IRT Pad, Heating, Powered Physical Medicine Class 2 890.5740 2008-07-16
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2018-10-15
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2015-11-10
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 2019-03-20
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2007-12-05
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2007-12-05
LHD Device, Fertility Diagnostic, Proceptive Unknown Class U N/A 2008-01-28
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2017-07-24
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2015-11-10
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2010-11-23
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2008-09-17
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2008-09-17
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2008-09-17
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2023-02-21
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2008-09-16
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2020-08-12
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2023-10-29
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 2008-09-17
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2008-09-12
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2008-09-17
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2019-07-25
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2007-12-05
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2008-09-17
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2008-09-16
BZH Meter, Peak Flow, Spirometry Anesthesiology Class 2 868.1860 2008-09-17
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2021-05-25
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2008-09-17
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 2010-12-02
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2016-12-08
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2008-09-17
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2020-08-12
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 2008-09-17
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2008-09-17
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2023-02-21
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 2015-12-18
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2008-11-26
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2014-07-07
BZH Meter, Peak Flow, Spirometry Anesthesiology Class 2 868.1860 2007-12-05
DPW Flowmeter, Blood, Cardiovascular Cardiovascular Class 2 870.2100 2007-12-05
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2008-09-17
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2008-09-17
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2010-06-23
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2008-09-17
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2008-11-23
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2014-08-25
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2023-07-12
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2013-03-08
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2020-02-28
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2008-01-28
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2007-12-05
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2010-12-02
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2023-06-05
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2011-12-14

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
3016867013 ONFU electronics Co., LTD. Trang Bom Dong Nai, VN
3003993690 MICROLIFE INTELLECTUAL PROPERTY GMBH Widnau Sankt Gallen, CH
9680225 ONBO ELECTRONIC (SHENZHEN) CO. LTD. SHENZHEN Guangdong, CN

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K100940 Andon Health Co, Ltd. FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5965 2010-06-29
K251581 Shenzhen Hingmed Medical Instrument Co., Ltd. Wearable Ambulatory Blood Pressure Monitor (WBP-02A) 2026-02-13
K200521 Health & Life Co., Ltd. Full Automatic(NIBP) Blood Pressure Monitor 2020-06-12
K152003 Andon Health Co, Ltd. iHealth BP3L Wireless Blood Pressure Monitor 2015-09-24
K952827 Sein Electronics Co., Ltd. FULL AUTO WRIST BLOOD PRESSURE METER MODEL SE-5000 1996-11-14

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.

Similar Registrations

Registration Number Establishment Name Location
1062836 DIGICARE BIOMEDICAL TECHNOLOGY, INC. BOYNTON BEACH, FL, US
3006543075 SHANGHAI KODEA ECONOMIC AND TRADE DEVELOPMENT LIMI SHANGHAI, CN
3011912849 BODYTRACE San Jose, CA, US
3036999955 ZYBS CONSULTING LLC DBA ZYBS MEDICAL GROUP, DBA ZYBS MEDICAL Largo, MD, US
3019575688 AKTIIA SA Neuchatel, CH
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8020605. Last updated year: 2026. Please use registration number 8020605 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.