UDI CompassNo Certificate Found
Snapshot 2026-10-27 · Link to EUDAMED
Hyperfine, Inc.
SRN US-MF-000029806
manufacturer · Guilford, CT, US · 9 devices
351 New Whitfield Street, 06437
Devices
| Name | UDI-DI | Class | Badge |
|---|---|---|---|
| Back Pad | 00850043319030 | Class I | No Certificate Found Snapshot 2026-10-27 · Link to EUDAMED |
| Back Pad | 00850043319153 | Class I | No Certificate Found Snapshot 2026-10-27 · Link to EUDAMED |
| Foam Head Pad | 00850043319047 | Class I | No Certificate Found Snapshot 2026-10-27 · Link to EUDAMED |
| Head Stabilizer | 00850043319146 | Class I | No Certificate Found Snapshot 2026-10-27 · Link to EUDAMED |
| SQA Phantom (MRI Quality Assurance Phantom) | 00860000606134 | Class I | No Certificate Found Snapshot 2026-10-27 · Link to EUDAMED |
| Swoop Portable MR Imaging System | 00850043319160 | Class IIa | No Certificate Found Snapshot 2026-10-27 · Link to EUDAMED |
| Swoop® Portable MR Imaging® System | 00850043319009 | Class IIa | No Certificate Found Snapshot 2026-10-27 · Link to EUDAMED |
| Swoop Transmit and Receive Radio Frequency Head Coil | 00850043319023 | Class IIa | No Certificate Found Snapshot 2026-10-27 · Link to EUDAMED |
| Swoop Transmit and Receive Radio Frequency Head Coil | 00850043319184 | Class IIa | No Certificate Found Snapshot 2026-10-27 · Link to EUDAMED |