Profilatex, S.A. DE C.V.
MexicoFDA applicant, unverified FDA FEI 3002997683
- Devices
- 1
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA FEI
What Profilatex, S.A. DE C.V. makes
Profilatex, S.A. DE C.V. manufactures INSTINCT surgical sutures in variations including plain, dotted, and ultra-thin designs. These are absorbable or non-absorbable monofilament or multifilament sutures intended for use in soft tissue approximation and ligation during surgical procedures.
The company’s products fall under FDA Class II devices and are listed via 510(k) premarket notifications. The manufacturer is based in the United States.
Catalogue
Instinct; Plain, Dotted, Ultra Thin Ref K132390
Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 3002997683
- Address
- FEBRERO DE 1917 NO. 4,, MEXICO
Frequently asked questions
How many devices does Profilatex, S.A. DE C.V. have in the registry?
The registry currently lists 1 device for Profilatex, S.A. DE C.V.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Profilatex, S.A. DE C.V.'s devices?
Among its 1 most recently registered device, Profilatex, S.A. DE C.V. has devices listed in FDA 510(k) (1 device).
What risk classes do Profilatex, S.A. DE C.V.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Profilatex, S.A. DE C.V.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Profilatex, S.A. DE C.V. in the registry?
The most recently registered devices listed for Profilatex, S.A. DE C.V. include INSTINCT; PLAIN, DOTTED, ULTRA THIN.