Plasmatica, Ltd.
IsraelFDA applicant, unverified FDA
- Devices
- 4
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA establishment
What Plasmatica, Ltd. makes
Plasmatica, Ltd. manufactures endoscope cold plasma antifogging support sets and standalone antifogging units designed to reduce fogging on endoscope lenses during procedures. The Plasma Shield is a key product in this portfolio, addressing a common challenge in endoscopic imaging.
These devices are classified as Class II under US regulations and are listed in the FDA’s 510(k) and UDI registries. The company is based in the United States.
Catalogue
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
Plasma Shield Ref K221533
Regimes: 510(k) Registry: 510(k)
Company details
- DUNS number
- 532350462
- [email protected]
- Phone
- 1 (800) 280-2183
FDA establishments
- Plasmatica RaAnana Tel Aviv · IL FEI 3025306172
Frequently asked questions
How many devices does Plasmatica, Ltd. have in the registry?
The registry currently lists 4 devices for Plasmatica, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Plasmatica, Ltd.'s devices?
Among its 4 most recently registered devices, Plasmatica, Ltd. has devices listed in FDA 510(k) (1 device) and FDA GUDID (3 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Plasmatica, Ltd.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Plasmatica, Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Plasmatica, Ltd. in the registry?
The most recently registered devices listed for Plasmatica, Ltd. include Plasma Shield PLA-04, Plasma Shield 1.0 and Plasma Shield.
Which FDA establishments are linked to Plasmatica, Ltd.?
1 FDA establishment is linked to Plasmatica, Ltd. in the registry; they are listed on the company page.