WISE S.p.A.

Italy IT-MF-000012628 Last updated 23 Oct 2026

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Devices: 3
Registries: EUDAMEDGUDIDFDA
FDA recalls: 0

Catalogue3

WCS® Link Ref WSCC_4CH

Class I EUDAMEDFDA UDI Active
WISE Cortical Strip - WCS Ref WCS04S10A-00-002

Class III EUDAMED Active
WCS® Link Ref WSCC_4CH-001

Class I EUDAMEDFDA UDI Active

EUDAMED certificates3

Held under this manufacturer's EUDAMED registration, grouped by notified body; in force first, then by expiry.

POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. 1434 2 certificates

1434-MDR-005/2025 Amended

Technical documentation EU MDR

Issued
18 Jun 2025

Expires
17 Jun 2030

Reason
Other
1434-MDR-006/2025 Issued

Quality management system EU MDR

Issued
18 Jun 2025

Expires
17 Jun 2030

CERTIQUALITY S.r.l. 0546 1 certificate

70944 Issued

Quality management system EU MDR

Issued
21 Apr 2026

Expires
20 Apr 2031

Notified bodies

CERTIQUALITY S.r.l. 0546
POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. 1434

Information

Country: Italy
Address: 38, Michelangelo Buonarroti, Cologno Monzese, Italy
Website: wiseneuro.com
Email: [email protected]
PRRC contact: Roberto Cuzzupè
EUDAMED SRN: IT-MF-000012628
FDA FEI number: 3030387292