Aizoi s.r.l.

Certificate 084-00-00-MDR

Rev. 00Issued

Valid until: Oct 8, 2030

Certificate 084-00-00-MDR is a valid Quality management system issued to Aizoi s.r.l. and registered in EUDAMED. Valid until October 8, 2030. View the full certificate record on MD Atlas.

Overview

Certificate number: 084-00-00-MDR
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 0426084-00-00-MDR00

Validity

Issued: Oct 8, 2025
Valid from: Oct 8, 2025
Valid until: Oct 8, 2030

Manufacturer

Manufacturer: Aizoi s.r.l.
Manufacturer SRN: IT-MF-000026605
Manufacturer country: Italy

Notified body

Notified body: ITALCERT SRL
Notified body SRN: 0426
Notified body country: Italy

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: Yes
New device: No
Discard allowed: No
SSCP enabled: Yes
Mechanism of scrutiny: No
Intended medical purpose: No
SPP applicable: No
Conditions applicable: No
MOS outside EUDAMED: —
QMS/MOS type: Others

History

No status changes or preceding certificates are recorded.

Scope coverage

Class IIa2

2 scopes

Other active non-implantable devices for monitoring and/or diagnosis
Class IIa
GENERAL PURPOSE ELECTROCARDIOGRAPHS
Class IIa

Documents

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