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Sign in to claim this brandNOxBOX Limited
United Kingdom (ex Northern Ireland)·GB-MF-000009734
Last updated September 17, 2026
Information
- Country
- United Kingdom (ex Northern Ireland)
- Address
- 1 , Eurolink Gateway, Sittingbourne, United Kingdom (ex Northern Ireland)
- Website
- mhra.gov.uk
- —
- —
- [email protected]
- Phone
- —
- PRRC Contact
- Karen Ring
- EUDAMED SRN
- GB-MF-000009734
- FDA FEI Number
- 3012796317
- DUNS Number
- —
Catalogue (8)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Single-use delivery and sampling kit for Bunnell Life Pulse | NOXKIT-HFJV | EUDAMEDFDA UDI | Class IIa | Active |
| Single-use 10mm delivery and sampling kit | NOXKIT-1-10 | EUDAMEDFDA UDI | Class IIa | Active |
| Single-use kit for adapting 10 mm kit to 12 mm circuits | NOXKIT-2-12 | EUDAMEDFDA UDI | Class IIa | Active |
| Single-use 15mm delivery and sampling kit | NOXKIT-2-15 | EUDAMEDFDA UDI | Class IIa | Active |
| NOxFLOW sensor for use with NOxBOXi system | NOXFLOW-2 | EUDAMED | Class IIa | Active |
| NOxBOXi | NOXBOX-I, NOXDC-I | EUDAMED | Class IIb | Active |
| Emergency Backup Kit for the NOxBOXi system | NOXKIT-EMER | EUDAMED | Class IIa | Active |
| Single-use 22mm delivery and sampling kit | NOXKIT-2-22 | EUDAMEDFDA UDI | Class IIa | Active |
Related Companies
Authorised Representatives
Importers
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Notified Bodies
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Authorities
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FDA Recalls (3)
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 9, 2025 | Z-0028-2026 | — | open, classified | Fluctuations may be more likely to occur if the total flow through the device sensor (used by the device to determine flow) is less than the minimum device requirement of 0.5 LPM. In addition, dose fluctuations have been observed when Bunnel LifePulse HFJV system or conventional ventilators have the following device settings: low service pressures generally less than 3.0 PSI, a pressure difference greater than 5.0cm H2O; or at breath per minute rates of 300 (5 Hz). |
| Sep 9, 2025 | Z-0029-2026 | — | open, classified | The unexpected internal fault / system diagnostic error to result when a rapid succession of button selections is made to the user interface without waiting for the device to respond to user prompts. |
| Jul 19, 2023 | Z-2544-2025 | — | open, classified | Replacement of the internal Sample Pump due to high failure rates. |
FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Noxbox Ltd US