WISE Cortical Strip - WCS
by WISE S.p.A. Italy EUDAMED
Ref WCS04S10A-00-002, WCS04S10A-00-003 EMDN N0101020101
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number805116096A000AAA0JK | Date28 Jul 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
- 1434-MDR-005/2025 Amended
Technical documentation EU MDR
- Notified body
- POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. 1434
- Issued
- 18 Jun 2025
- Expires
- 17 Jun 2030
- Reason
- Other
Specification
- Trade Name
- WISE Cortical Strip - WCSWISE Cortical Strip
- Model / Reference
- WCS04S10A-00-002, WCS04S10A-00-003
- Primary DI / UDI-DI
- 18051160960047, 18051160960054
- Basic UDI-DI
- 805116096A000AAA0JK
- EMDN Code
- N0101020101 EEG cortical electrodes
- Device Class
- Class III
- Market of Registration
- Italy
Manufacturer details
- EUDAMED SRN
- IT-MF-000012628
Other devices from WISE S.p.A.
Properties & raw data
Show properties, registry sources and raw records
Other properties (12)
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
Sources (2)
- EUDAMED 03cf0746-949f-48a8-b0cd-26f2b9a1ac28
- EUDAMED 18051160960054|805116096A000AAA0JK