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Sign in to claim this brandQvella Corporation
US
Last updated May 30, 2026
Information
- Country
- US
- Address
- —
- Website
- qvella.com
- —
- —
- [email protected]
- Phone
- 833-478-3552
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 251371170
Catalogue (2)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| FAST PBC Prep Cartridge | 1 | FDA UDI | Class I | Active |
| FAST Instrument | 1 | FDA UDI | Class I | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
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Notified Bodies
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Authorities
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FDA Recalls (1)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Nov 2, 2022 | Z-0425-2023 | — | open, classified | Device exceeds the limitations of a Class I 510(k)-exempt device so the user manual, instructions for use, and promotional materials are being corrected to remove all references to downstream applications. |