Saliwell, Ltd.
IsraelFDA 510(k) applicant, unverified FDA
- Devices
- 5
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA establishment
What Saliwell, Ltd. makes
Saliwell, Ltd. manufactures electrical stimulators designed to treat dry mouth by stimulating saliva production. The devices include portable pen-style stimulators (e.g., SaliPen) and a handheld unit (GenNarino) for targeted salivary gland activation.
The company’s products are regulated as Class II devices in the US, with authorisations recorded via FDA 510(k) and UDI registries. The manufacturer is based in the United States.
Catalogue
Company details
- DUNS number
- 533732749
FDA establishments
- Saliwell Ltd. Harutzim Central · IL FEI 3015282800
Frequently asked questions
How many devices does Saliwell, Ltd. have in the registry?
The registry currently lists 5 devices for Saliwell, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Saliwell, Ltd.'s devices?
Among its 5 most recently registered devices, Saliwell, Ltd. has devices listed in FDA 510(k) (4 devices) and FDA GUDID (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Saliwell, Ltd.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Saliwell, Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Saliwell, Ltd. in the registry?
The most recently registered devices listed for Saliwell, Ltd. include SaliPen OTC, SaliPen and GenNarino.
Which FDA establishments are linked to Saliwell, Ltd.?
1 FDA establishment is linked to Saliwell, Ltd. in the registry; they are listed on the company page.