Data / Medical devices / United Kingdom / Biotronics 3D Limited
Biotronics 3D Limited: FDA-registered device maker in London London, City of, United Kingdom, 1 510(k) clearance
Biotronics 3D Limited is registered with the FDA (registration 3031755019) in London London, City of, United Kingdom. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated April 24, 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
- 3031755019
- Address
- 1 First Floor Offices, Suite 3 1 Duchess Street, London London, City of, United Kingdom, W1W 6AN
- Owner or operator
- Biotronics 3D Limited (10091168)
- Roles
- Manufacturer
- First device listed
- July 16, 2024
- Registered through
- 2026
- Brand names listed
- 3Dnet
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Image Processing, Radiological | LLZ | 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 |
|---|---|---|---|---|---|---|
| April 24, 2024 | K240839 | OpenRad Cloud | LLZ | Substantially Equivalent | Openrad Services Uk, Ltd. | accessdata.fda.gov |
Compare with other makers
Updated April 24, 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.