Data / Medical devices / United Kingdom / Emboss Medical Limited
Emboss Medical Limited: FDA-registered device maker in London London, City of, United Kingdom, 1 510(k) clearance
Emboss Medical Limited is registered with the FDA (registration 3017907745) 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 September 18, 2015. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3017907745
- Address
- 128 City Road, London London, City of, United Kingdom, EC1V 2NX
- Owner or operator
- Emboss Medical Limited (10079807)
- Roles
- Exporter to the US, Specification developer
- First device listed
- December 24, 2020
- Registered through
- 2026
- Brand names listed
- Circumplast
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Clamp, Circumcision | HFX | 2 | Exporter to the US, Specification developer | 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 |
|---|---|---|---|---|---|---|
| September 18, 2015 | K151095 | Circumplast Circumcision Device | HFX | Substantially Equivalent | Novadien Healthcare | accessdata.fda.gov |
Compare with other makers
Updated September 18, 2015. 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.