MicroTech Medical (Hangzhou) Co.,Ltd.

Certificate HZ 1582538-1

Rev. Rev.2Amended

Valid until: Sep 3, 2029

Certificate HZ 1582538-1 is a valid Quality management system issued to MicroTech Medical (Hangzhou) Co.,Ltd. and registered in EUDAMED. Valid until September 3, 2029. View the full certificate record on MD Atlas.

Overview

Certificate number: HZ 1582538-1
Certificate type: Quality management system
Certificate status: Amended
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 3
Certificate ID: 0197HZ 1582538-1Rev.2

Validity

Issued: Jan 23, 2026
Valid from: Jan 23, 2026
Valid until: Sep 3, 2029

Manufacturer

Manufacturer: MicroTech Medical (Hangzhou) Co.,Ltd.
Manufacturer SRN: CN-MF-000001157
Manufacturer country: China

Notified body

Notified body
Notified body SRN: 0197
Notified body country: Germany

Covered devices

No specific devices are listed for this certificate.

Characteristics

Sterile: Yes
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: No
Intended medical purpose: No
SPP applicable

History

Status changes

Amended

Supersedes

HZ 1582538-1Quality management systemSupplementedOct 9, 2024 → Sep 3, 2029

Scope coverage

Class IIb1

1 scope

Z120401 - GENERAL MEDICINE INSTRUMENTS GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - Continuous Glucose Monitoring System Sensor - Continuous Glucose Monitoring App - Continuous Glucose Monitoring System Transmitter - Continuous Glucose Monitoring System PDA
Class IIb

Documents

LanguagesEN