Scandinavian Health Limited
Country not established FDA
- Devices
- 4
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA establishment
What Scandinavian Health Limited makes
Scandinavian Health Limited makes push-on needles and auto-injectors, including the PUSH-ON NEEDLE 30GX8MM, LOBSTER AUTO-INJECTOR, and WHISPERJECT AUTOINJECTOR.
These devices are classified as Class II medical devices and are listed in the FDA 510(k) registry; the company is based in the United States.
Catalogue
Push-On Needle 30GX8MM Ref K120191
Regimes: 510(k) Registry: 510(k)Lobster Auto-Injector Ref K124026
Regimes: 510(k) Registry: 510(k)Pen-Inject 2.25 Ref K954729
Regimes: 510(k) Registry: 510(k)Whisperject Autoinjector Ref K141384
Regimes: 510(k) Registry: 510(k)
FDA establishments
- Scandinavian Health Ltd. Taoyuan City · TW FEI 3004483565
Frequently asked questions
How many devices does Scandinavian Health Limited have in the registry?
The registry currently lists 4 devices for Scandinavian Health Limited. Devices recorded under merged duplicate company entries are counted once.
Which registries list Scandinavian Health Limited's devices?
Among its 4 most recently registered devices, Scandinavian Health Limited has devices listed in FDA 510(k) (4 devices).
What risk classes do Scandinavian Health Limited's devices fall under?
Among its 4 most recently registered devices, the classes recorded for Scandinavian Health Limited's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Scandinavian Health Limited in the registry?
The most recently registered devices listed for Scandinavian Health Limited include PUSH-ON NEEDLE 30GX8MM, LOBSTER AUTO-INJECTOR, PEN-INJECT 2.25 and WHISPERJECT AUTOINJECTOR.
Which FDA establishments are linked to Scandinavian Health Limited?
1 FDA establishment is linked to Scandinavian Health Limited in the registry; they are listed on the company page.