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Sign in to claim this brandAZURE BIOTECH INC
US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 10400 Main Street, Houston, TX, 77025
- Website
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- —
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- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 3014862351
- DUNS Number
- —
Catalogue (12)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Fastep | COV-S35002H1 | FDA UDI | N | Active |
| Fastep | COV-S23010H2 | FDA UDI | N | Active |
| Fastep | AZC-8105 | FDA UDI | N/A | Active |
| Fastep | AZC-6125 | FDA UDI | N/A | Active |
| Fastep | COV-S23010H5 | FDA UDI | N | Active |
| Fastep | COV-S23010H1 | FDA UDI | N | Active |
| Fastep | COV-S23010H4 | FDA UDI | N | Active |
| Fastep | COV-S35002H4 | FDA UDI | N | Active |
| Fastep | COV-S35002H2 | FDA UDI | N | Active |
| Fastep | COV-S35002H20 | FDA UDI | N | Active |
| Fastep | COV-S23010H25 | FDA UDI | N | Active |
| Fastep | COV-S23010H25 | FDA UDI | N | 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 |
|---|---|---|---|---|
| Mar 2, 2021 | Z-1432-2021 | — | terminated | Due to Products being incorrect labeling "for diagnostic use" and labelled with an unsupported 24 month expiration dating. |