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Sign in to claim this brandNoah Medical Corp.
US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 1391 Geneva Dr, Sunnyvale, CA, 94089
- Website
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- Phone
- —
- PRRC Contact
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- EUDAMED SRN
- —
- FDA FEI Number
- 3027205723
- DUNS Number
- —
Catalogue (7)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Galaxy System | GAL-001 | FDA UDI | Class II | Active |
| Accessory Kit | 10000799 | FDA UDI | Class II | Active |
| Bronchoscope connector | 10000339 | FDA UDI | Class II | Active |
| Bronchoscope guide | 10000307 | FDA UDI | Class II | Active |
| Bronchoscope | 10000769 | FDA UDI | Class II | Active |
| Basic Accessory Kit | 10000111 | FDA UDI | Class II | Unknown |
| Galaxy System | K223144 | FDA 510(k) | Class II | 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 (5)
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 |
|---|---|---|---|---|
| Sep 12, 2025 | Z-0598-2026 | — | open, classified | Due to Users not having access to the Instructions for Use/User Manual due to it being password protected. |
| Oct 28, 2024 | Z-0742-2025 | — | open, classified | Bronchoscopic visualization system power supplies have defective semiconductor components that may fail unexpectedly, which could result in an aborted procedure since it is a non recoverable failure. Manual removal of the bronchoscope when the system is not functioning can increase the chance of injury to the tissues of the lung as the scope is withdrawn including the possibility of pneumothorax. |
| Oct 25, 2024 | Z-0679-2025 | — | open, classified | Not all biopsy tools meant to fit bronchoscope channel (2.1mm inner diameter/length greater or equal to 1100mm) will pass through if scope channel positioned in sharp bend (approx. greater than 100-deg.), excessive force may result in tissue injury/pneumothorax; instruments with long rigid distal sections may exhibit insertion resistance when bronchoscope bending section significantly articulated. |
| Oct 25, 2024 | Z-0693-2025 | — | open, classified | Bronchoscopic system uninterruptable power may have defective component, may cause power supply short circuit/trip protective circuit breakers causing sudden, unrecoverable power loss, which could occur while system is on mains or internal battery power; if during procedure, could cause interrupted/aborted procedure, may necessitate manual removal, which could lead to lung injury/pneumothorax. |
| Mar 9, 2024 | Z-1734-2024 | — | open, classified | Due to a misaligned calibration of the wired controller that may result in unintended motion of the scope. |