Data / Medical devices / France / Laboratoires Brothier, S.A.
Laboratoires Brothier, S.A.: FDA-registered device maker in FONTEVRAUD L ABBAYE Maine-et-Loire, France, 1 510(k) clearance
Laboratoires Brothier, S.A. is registered with the FDA (registration 8043838) in FONTEVRAUD L ABBAYE Maine-et-Loire, France. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated February 2, 2011. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 8043838
- FEI number
- 3004728227
- Address
- Zone Artisanale-B.p. 26, FONTEVRAUD L ABBAYE Maine-et-Loire, France, F-49590
- Owner or operator
- LABORATOIRES BROTHIER, S.A. (9004082)
- Roles
- Manufacturer
- First device listed
- March 26, 1999
- Registered through
- 2026
- Brand names listed
- ENTAXIS NASAL PACKING, NasalCEASE and BleedCEASE
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Balloon, Epistaxis | EMX | 1 | Manufacturer | accessdata.fda.gov |
| Hemostatic Wound Dressing Without Thrombin Or Other Biologics | QSY | U | 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 |
|---|---|---|---|---|---|---|
| February 2, 2011 | K102742 | NASAL CEASE | QSY | Substantially Equivalent | Catalina, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Balloon, Epistaxis
- All makers of Hemostatic Wound Dressing Without Thrombin Or Other Biologics
Updated February 2, 2011. 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.