WISE S.p.A.

Certificate 1434-MDR-005/2025

Rev. 2/19.02.2026/ S/024/BM/2023Amended

Valid until: Jun 17, 2030

Certificate 1434-MDR-005/2025 is a valid Technical documentation issued to WISE S.p.A. and registered in EUDAMED. Valid until June 17, 2030. View the full certificate record on MD Atlas.

Overview

Certificate number: 1434-MDR-005/2025
Certificate type: Technical documentation
Certificate status: Amended
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 2
Certificate ID: 14341434-MDR-005/20252/19.02.2026/ S/024/BM/2023

Validity

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

Notified body

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

Characteristics

Sterile: —
Human tissues: —
Animal tissues: —
In vitro diagnostics: —
Initial registration: No
New device: No
Discard allowed: No
SSCP enabled: Yes
Mechanism of scrutiny: No
Intended medical purpose: —
SPP applicable: —
Conditions applicable: No
MOS outside EUDAMED: No
QMS/MOS type: Others

History

Status changes

Amended

Supersedes

1434-MDR-005/2025Technical documentationIssuedJun 18, 2025 → Jun 17, 2030

Scope coverage

Unspecified1

1 scope

WISE Cortical Strip
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