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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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MD Atlas
Documents

WISE S.p.A.

Certificate 1434-MDR-006/2025

Rev. 1/18.06.2025/ S/024/BM/2023Issued

Valid until: Jun 17, 2030

Overview

Certificate number: 1434-MDR-006/2025
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 14341434-MDR-006/20251/18.06.2025/ S/024/BM/2023

Validity

Issued: Jun 18, 2025
Valid from: Jun 18, 2025
Valid until: Jun 17, 2030

Manufacturer

Manufacturer: WISE S.p.A.
Manufacturer SRN: IT-MF-000012628
Manufacturer country: Italy

Notified body

Notified body: POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.
Notified body SRN: 1434
Notified body country: Poland

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: Yes
New device: No
Discard allowed: No
SSCP enabled: No
Mechanism of scrutiny: No
Intended medical purpose: Yes
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 III2

2 scopes

N0101020101 - EEG CORTICAL ELECTRODES
Class III
WISE Cortical Strip – WCS®
Class III

Documents

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