Ibsa Institut Biochimique SA
Country not established FDA
- Devices
- 1
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA establishment
What Ibsa Institut Biochimique SA makes
Ibsa Institut Biochimique SA manufactures Gel-Syn™, a medical-grade gel used for specific surgical applications requiring tissue adhesion or barrier formation. This product is designed to support procedures where controlled interaction with biological tissues is critical.
The company’s portfolio is regulated under Class III devices in the United States, with Gel-Syn™ authorised through a Premarket Approval (PMA) application. The manufacturer operates from the US and has its products listed in the FDA’s PMA registry.
Catalogue
Gel-Syn™ Ref P110005
PMA PMA
FDA establishments
- Ibsa Institut Biochimique SA Pazzallo Ticino · CH FEI 3002864272
Frequently asked questions
How many devices does Ibsa Institut Biochimique SA have in the registry?
The registry currently lists 1 device for Ibsa Institut Biochimique SA. Devices recorded under merged duplicate company entries are counted once.
Which registries list Ibsa Institut Biochimique SA's devices?
Among its 1 most recently registered device, Ibsa Institut Biochimique SA has devices listed in FDA PMA (1 device).
What risk classes do Ibsa Institut Biochimique SA's devices fall under?
Among its 1 most recently registered device, the classes recorded for Ibsa Institut Biochimique SA's devices are Class III. Each device page shows its own class and authorisation.
What are the newest devices from Ibsa Institut Biochimique SA in the registry?
The most recently registered devices listed for Ibsa Institut Biochimique SA include Gel-Syn™.
Which FDA establishments are linked to Ibsa Institut Biochimique SA?
1 FDA establishment is linked to Ibsa Institut Biochimique SA in the registry; they are listed on the company page.