Hindernis DE Mexico, S.A.P.I. DE C.V.
MexicoFDA applicant, unverified
- Devices
- 1
What Hindernis DE Mexico, S.A.P.I. DE C.V. makes
Hindernis DE Mexico, S.A.P.I. DE C.V. manufactures BAÜMER Surgical Gowns, including variants for specific surgical procedures (COP01, COP04, COP05, COP10). These products are designed for single-use in sterile surgical environments to protect healthcare personnel and patients from contamination during medical procedures.
The company’s surgical gowns are classified as Class II medical devices and are listed under the FDA’s 510(k) pathway. The products are intended for use in Mexico, where the manufacturer is based.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Hindernis DE Mexico, S.A.P.I. DE C.V. have in the registry?
The registry currently lists 1 device for Hindernis DE Mexico, S.A.P.I. DE C.V.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Hindernis DE Mexico, S.A.P.I. DE C.V.'s devices?
Among its 1 most recently registered device, Hindernis DE Mexico, S.A.P.I. DE C.V. has devices listed in FDA 510(k) (1 device).
What risk classes do Hindernis DE Mexico, S.A.P.I. DE C.V.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Hindernis DE Mexico, S.A.P.I. DE C.V.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Hindernis DE Mexico, S.A.P.I. DE C.V. in the registry?
The most recently registered devices listed for Hindernis DE Mexico, S.A.P.I. DE C.V. include BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10).