Bioscaffold International Pte, Ltd.
ItalyFDA applicant, unverified
- Devices
- 1
What Bioscaffold International Pte, Ltd. makes
Bioscaffold International Pte, Ltd. manufactures resorbable scaffolds designed for tissue regeneration, including the BIOSCAFF ALVELAC scaffold, which is intended for vascular applications.
The company’s products are regulated as Class II medical devices under the FDA’s 510(k) pathway and are listed in the U.S. regulatory system. The company is based in the United States.
Catalogue
Bio-Scaffold Bioscaff Alvelac Resobable Scaffold Ref K080308
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Bioscaffold International Pte, Ltd. have in the registry?
The registry currently lists 1 device for Bioscaffold International Pte, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Bioscaffold International Pte, Ltd.'s devices?
Among its 1 most recently registered device, Bioscaffold International Pte, Ltd. has devices listed in FDA 510(k) (1 device).
What risk classes do Bioscaffold International Pte, Ltd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Bioscaffold International Pte, Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Bioscaffold International Pte, Ltd. in the registry?
The most recently registered devices listed for Bioscaffold International Pte, Ltd. include BIO-SCAFFOLD BIOSCAFF ALVELAC RESOBABLE SCAFFOLD.