Microlife Corporation

Certificate TW023/00000625

Rev. 7Supplemented

Valid until: Aug 24, 2028

Certificate TW023/00000625 is a valid Quality management system issued to Microlife Corporation and registered in EUDAMED. Valid until August 24, 2028. View the full certificate record on MD Atlas.

Overview

Certificate number: TW023/00000625
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 7
Certificate ID: 1639TW023/000006257

Validity

Issued: Dec 17, 2025
Valid from: Dec 17, 2025
Valid until: Aug 24, 2028

Manufacturer

Manufacturer
Manufacturer SRN: TW-MF-000010688
Manufacturer country: Taiwan

Notified body

Notified body
Notified body SRN: 1639
Notified body country: Belgium

Covered devices

No specific devices are listed for this certificate.

Characteristics

Sterile: No
Human tissues: No
Animal tissues: No
In vitro diagnostics: No
Initial registration: No
New device: No
Discard allowed: No
SSCP enabled: Yes
Mechanism of scrutiny: Yes
Intended medical purpose: No
SPP applicable

History

Status changes

Supplemented

Supersedes

TW023/00000625Quality management systemAmendedFeb 18, 2025 → Aug 24, 2028

Scope coverage

Class IIa8Class I2Class IIb1

10 scopes

MDA0203, MDS1010
Class IIaClass IIb
MDN1207, MDS1010
Class I
Blood Pressure Long-term Ambulatory Recorder Series
Class IIa
Digital Non-invasive Blood Pressure Monitor for Home Use Series
Class IIa
Digital Infrared Thermometer Series
Class IIa
Digital Thermometer Series
Class IIa
Digital Non-invasive Blood Pressure Monitors for Professional Use Series
Class IIa
Digital Peak Flow Meters Series
Class IIa
Aneroid Sphygmomanometer series
Class I
Digital Non-invasive Blood Pressure and Electrocardiogram Monitor Series
Class IIa

Documents

LanguagesEN