Shl Medical, USA
Country not established
- Devices
- 2
What Shl Medical, USA makes
Shl Medical produces disposable autoinjectors designed for single-use administration of medications, including the SHL DISPOSABLE AUTOINJECTOR and the DAI-R model. These devices are engineered for ease of use in emergency or self-administered scenarios, ensuring precise dosing without the need for manual injection training. They are intended for use with specific pharmaceuticals to deliver treatments in clinical or home settings.
The company’s portfolio is regulated under Class II medical devices in the United States, with individual products authorised through the FDA’s 510(k) clearance process. The devices are listed in the FDA’s 510(k) database, adhering to U.S. regulatory requirements for safety and performance. Shl Medical operates as a U.S.-based manufacturer, focusing on compliance with domestic medical device regulations.
Catalogue
Shl Disposable Autoinjector Ref K050434
Regimes: 510(k) Registry: 510(k)Dai-R Ref K060141
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Shl Medical, USA have in the registry?
The registry currently lists 2 devices for Shl Medical, USA. Devices recorded under merged duplicate company entries are counted once.
Which registries list Shl Medical, USA's devices?
Among its 2 most recently registered devices, Shl Medical, USA has devices listed in FDA 510(k) (2 devices).
What risk classes do Shl Medical, USA's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Shl Medical, USA's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Shl Medical, USA in the registry?
The most recently registered devices listed for Shl Medical, USA include SHL DISPOSABLE AUTOINJECTOR and DAI-R.