SenSight™
by Medtronic, Inc. 38 variants
Ref B31010
SenSight™ (B31010) is a Class III device made by Medtronic, Inc., registered in EUDAMED on 15 Sep 2026 (Basic UDI-DI 0763000B00024498E) with CE/MDR certificate G70 039709 1513 valid until 16 Dec 2029, active as of 23 Oct 2026.
Active
CE MDR
Valid until
16 Dec 2029
FDA recalls
Not applicable
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number0763000B00024498E 00763000949648 | Date15 Sep 2026 | StatusActive |
Official records
- EUDAMED public site 0763000B00024498E
Certificates
- G70 039709 1513 Active
Technical documentation EU MDR
- Certifier
- TÜV SÜD Product Service GmbH 0123
- Issued
- 10 Aug 2026
- Expires
- 16 Dec 2029
- Reason
- Add device or group
Timeline
- Certificate issued EUDAMED G70 039709 1513
- Registered EUDAMED 0763000B00024498E
- Certificate expires EUDAMED G70 039709 1513
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device name
- SenSight™ Depth Stop & Cranial Tunneler
- Model / reference
- B31010
- Primary DI / UDI-DI
- 00763000949648
- Basic UDI-DI
- 0763000B00024498E
- EMDN code
- J020180 Cerebral implantable neurostimulators - accessories
- Device class
- Class III
- EU registration type
- Standard device
- EU market of registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- US-MF-000019977
- Authorised representative
- Medtronic B.V. NL-AR-000006050
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