Sphere-9™
Ref AFR-00001
Sphere-9™ (AFR-00001) is a Class III device made by Medtronic, Inc., registered in EUDAMED on 11 Jun 2026 (Basic UDI-DI 0763000B000262284) with CE/MDR certificate G70 039709 1510 valid until 26 Jan 2028, active as of 24 Oct 2026.
Active
CE MDR
Valid until
26 Jan 2028
FDA recalls
Not applicable
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberG70 039709 1510 | Date30 Jul 2026 | StatusActive |
Official records
- EUDAMED public site 0763000B000262284
Certificates
- G70 039709 1510 Active
Technical documentation EU MDR
- Certifier
- TÜV SÜD Product Service GmbH 0123
- Issued
- 30 Jul 2026
- Expires
- 26 Jan 2028
- Reason
- Add device or group
Timeline
- Registered EUDAMED 0763000B000262284
- Certificate issued EUDAMED G70 039709 1510
- Certificate expires EUDAMED G70 039709 1510
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device name
- Sphere 9 Catheter
- Model / reference
- AFR-00001
- Primary DI / UDI-DI
- 00763000973384
- Basic UDI-DI
- 0763000B000262284
- EMDN code
- C020399 Cardiac tissue ablation devices - other
- 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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