Ferrosan Medical Devices Sp. Z.O.O.
PolandFDA applicant, unverified FDA
- Devices
- 7
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA establishment
What Ferrosan Medical Devices Sp. Z.O.O. makes
Ferrosan Medical Devices produces the Certa Catheter, a medical device designed for specific vascular procedures.
The Certa Catheter is classified as a Class II device under FDA regulations and is listed via the 510(k) pathway. The company is based in the United States.
Catalogue
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
Certa Catheter Ref K171193
Regimes: 510(k) Registry: 510(k)
Company details
- DUNS number
- 426737794
FDA establishments
- Ferrosan Medical Devices Sp. z o.o. Szczecin Zachodniopomorskie · PL FEI 3007162296
Frequently asked questions
How many devices does Ferrosan Medical Devices Sp. Z.O.O. have in the registry?
The registry currently lists 7 devices for Ferrosan Medical Devices Sp. Z.O.O.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Ferrosan Medical Devices Sp. Z.O.O.'s devices?
Among its 7 most recently registered devices, Ferrosan Medical Devices Sp. Z.O.O. has devices listed in FDA 510(k) (1 device) and FDA GUDID (6 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Ferrosan Medical Devices Sp. Z.O.O.'s devices fall under?
Among its 7 most recently registered devices, the classes recorded for Ferrosan Medical Devices Sp. Z.O.O.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Ferrosan Medical Devices Sp. Z.O.O. in the registry?
The most recently registered devices listed for Ferrosan Medical Devices Sp. Z.O.O. include Certa Catheter R120D1, Certa Catheter R75D1, Certa Catheter R50D1 and Certa Catheter R75C1.
Which FDA establishments are linked to Ferrosan Medical Devices Sp. Z.O.O.?
1 FDA establishment is linked to Ferrosan Medical Devices Sp. Z.O.O. in the registry; they are listed on the company page.