Medicamat S.A.
Country not established
- Devices
- 2
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Medicamat S.A. makes
Medicamat S.A. manufactures the B.U.S. ENDOTRON, a device used in endoscopic procedures, and the CALVITRON HAIR TRANSPLANT SYSTEM, which assists in hair restoration through transplantation techniques.
The company’s portfolio includes devices classified as Class I and Class II (Unclassified), with products listed under the FDA’s 510(k) pathway. Medicamat S.A. is based in the United States.
Catalogue
B.U.S. Endotron Ref K972148
Regimes: 510(k) Registry: 510(k)Calvitron Hair Transplant System Ref K952737
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 1 recall initiated by Medicamat S.A., initiated on 2013-02-18. By recorded status: 1 terminated. The reasons filed fall into these groups: other reasons as filed. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2013
- 18 Feb 2013 Z-1129-2014 Class II Terminated Medicamat is initiating a field correction due to misbranded marketing literature for the Punch Hair Matic SAFER.
Frequently asked questions
How many devices does Medicamat S.A. have in the registry?
The registry currently lists 2 devices for Medicamat S.A.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Medicamat S.A.'s devices?
Among its 2 most recently registered devices, Medicamat S.A. has devices listed in FDA 510(k) (2 devices).
What risk classes do Medicamat S.A.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Medicamat S.A.'s devices are Class I. Each device page shows its own class and authorisation.
Are there FDA recall records for Medicamat S.A.?
FDA recall records list 1 recall initiated by Medicamat S.A., the most recent initiated on 18 Feb 2013. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Medicamat S.A. in the registry?
The most recently registered devices listed for Medicamat S.A. include B.U.S. ENDOTRON and CALVITRON HAIR TRANSPLANT SYSTEM.