Biom'Up SAS
FranceFDA applicant, unverified
- Devices
- 2
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Biom'Up SAS makes
Biom'Up Sas makes resorbable collagen membranes, including products like COVAORTHO-NERVE RESORBABLE COLLAGEN MEMBRANE and COVAMAX RESORBABLE COLLAGEN MEMBRANE. These are types of medical devices used in surgical procedures.
The company's portfolio is regulated as Class II devices and is listed in the FDA 510(k) registry. Biom'Up Sas is based in the US.
Catalogue
Covaortho-Nerve Resorbable Collagen Membrane Ref K103081
Regimes: 510(k) Registry: 510(k)Covamax Resorbable Collagen Membrane Ref K103087
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 1 recall initiated by Biom'Up Sas, initiated on 2016-12-02. By recorded status: 1 terminated. The reasons filed fall into these groups: sterility or contamination. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2016
- 2 Dec 2016 Z-1110-2017 Class II Terminated Lack of sterility assurance
Frequently asked questions
How many devices does Biom'Up Sas have in the registry?
The registry currently lists 2 devices for Biom'Up Sas. Devices recorded under merged duplicate company entries are counted once.
Which registries list Biom'Up Sas's devices?
Among its 2 most recently registered devices, Biom'Up Sas has devices listed in FDA 510(k) (2 devices).
What risk classes do Biom'Up Sas's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Biom'Up Sas's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Biom'Up Sas?
FDA recall records list 1 recall initiated by Biom'Up Sas, the most recent initiated on 2 Dec 2016. 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 Biom'Up Sas in the registry?
The most recently registered devices listed for Biom'Up Sas include COVAORTHO-NERVE RESORBABLE COLLAGEN MEMBRANE and COVAMAX RESORBABLE COLLAGEN MEMBRANE.