Andon Health Co., Ltd.

Certificate HZ 2095583-1

Rev. 1Supplemented

Valid until: Oct 9, 2029

Certificate HZ 2095583-1 is a valid Quality management system issued to Andon Health Co., Ltd. and registered in EUDAMED. Valid until October 9, 2029. View the full certificate record on MD Atlas.

Overview

Certificate number: HZ 2095583-1
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 2
Certificate ID: 0197HZ 2095583-11

Validity

Issued: Aug 8, 2025
Valid from: Aug 8, 2025
Valid until: Oct 9, 2029

Manufacturer

Manufacturer: Andon Health Co., Ltd.
Manufacturer SRN: CN-MF-000001799
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: 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: No
Intended medical purpose: No
SPP applicable

History

Status changes

Supplemented

Supersedes

HZ 2095583-1Quality management systemIssuedOct 10, 2024 → Oct 9, 2029

Scope coverage

Class IIa1

1 scope

Z120302 - VITAL SIGNS MONITORING INSTRUMENTS Z120628 - NEUROMUSCULAR STIMULATION EQUIPMENT V030101 - THERMOMETERS Z120306 - VITAL SIGNS TELEMETRY INSTRUMENTS (ECG, NIPB, EtCO2, SpO2, RESPIRATION,...) V9099 - VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER
Class IIa

Documents

LanguagesEN