Data / Medical devices / United Kingdom / Huma Therapeutics Limited
Huma Therapeutics Limited: FDA-registered device maker in London England, United Kingdom, 2 510(k) clearances
Huma Therapeutics Limited is registered with the FDA (registration 3016670256) in London England, United Kingdom. It lists 4 device types. The FDA files 2 510(k) clearances under its listings, the newest dated November 25, 2024. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3016670256
- Address
- 13th Floor Millbank Tower 21-24 Millbank, Westminster, London England, United Kingdom, SW1P 4QP
- Owner or operator
- HUMA THERAPEUTICS LIMITED (10064143)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- December 21, 2021
- Registered through
- 2026
- Brand names listed
- Aluna Care, HUMA App, Huma RPM
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Medical Device Data System | OUG | 1 | Manufacturer | accessdata.fda.gov |
| Meter, Peak Flow, Spirometry | BZH | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | MWI | 2 | Manufacturer | accessdata.fda.gov |
| System, Network And Communication, Physiological Monitors | MSX | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 25, 2024 | K232588 | Aluna 2 | BZH | Substantially Equivalent | Knox Medical Diagnostics | accessdata.fda.gov |
| June 2, 2023 | K230214 | Huma RPM (RPM) | MWI | Substantially Equivalent | Medopad, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Medical Device Data System
- All makers of Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
- All makers of System, Network And Communication, Physiological Monitors
- All makers of Meter, Peak Flow, Spirometry
Updated November 25, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.