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US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 4201 Burton Drive, Santa Clara, CA, 95054
- Website
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- Phone
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- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 3017487805
- DUNS Number
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Catalogue (7)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Exo Iris | EI2001 | FDA UDI | Class II | Active |
| Exo Iris Ultrasound System | EI2001 | FDA UDI | Class II | Active |
| Exo Works | EW1001 | FDA UDI | Class I | Active |
| AI Platform 2.0 (AIP002) | K240953 | FDA 510(k) | Class II | Active |
| Exo Iris (El2001) | K222198 | FDA 510(k) | Class II | Active |
| Exo Iris | K211527 | FDA 510(k) | Class II | Active |
| AI Platform 2.2 (AIP002) | K260217 | FDA 510(k) | Class II | Active |
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