Data / Medical devices / France / Bodycap
Bodycap: FDA-registered device maker in Herouville Saint-Clair Calvados, France, 1 510(k) clearance
Bodycap is registered with the FDA (registration 3014271659) in Herouville Saint-Clair Calvados, France. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated June 28, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014271659
- Address
- 3 rue du docteur Laennec, Herouville Saint-Clair Calvados, France, 14200
- Owner or operator
- BodyCAP (10088770)
- Roles
- Manufacturer
- First device listed
- October 10, 2023
- Registered through
- 2026
- Brand names listed
- e-Celsius Medical System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Continuous Measurement Thermometer | FLL | 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 |
|---|---|---|---|---|---|---|
| June 28, 2023 | K210924 | e-Celsius Medical System | FLL | Substantially Equivalent | Bodycap | accessdata.fda.gov |
Compare with other makers
Updated June 28, 2023. 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.