MDR MDR QMS Issued

HZ 2095583-1

Manufacturer: Andon Health Co., Ltd.
Basic UDI-DIs
0
Scopes
1
Preceding Certs
0
Risk Classes
1
Characteristics
0
Revision
0

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1170
Valid for 1170 days
Expiry: October 9, 2029

Basic Information

Number
HZ 2095583-1
Type
MDR QMS
Legislation
MDR
Issue Date
October 10, 2024
Expiry Date
October 9, 2029
Manufacturer
Andon Health Co., Ltd.

Certificate Lifecycle

October 10, 2024 October 9, 2029

Scopes

Quality Procedure Scope

Device Group Class IIa

Z120302 - VITAL SIGNS MONITORING INSTRUMENTS Z120628 - NEUROMUSCULAR STIMULATION EQUIPMENT V030101 - THERMOMETERS Z120306 - VITAL SIGNS TELEMETRY INSTRUMENTS (ECG, NIPB, EtCO2, SpO2, RESPIRATION,...)

Basic UDI-DIs

This Certificate doesn't seem to be associated with any Basic UDI-DIs. If you think that sounds weird, so do we. But that's what the EUDAMED data seems to state.