Sturdy Industrial Co., Ltd.
Country not established FDA
- Devices
- 3
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA establishment
What Sturdy Industrial Co., Ltd. makes
Sturdy Industrial Co., Ltd. manufactures manual resuscitators and autoclaves, including the Sturdy Autoclave Super Microm and its variants (SA-260MA, SA-260MA-R). These devices are designed for sterilization and emergency respiratory support in medical settings.
The company’s products are classified as Class II devices under FDA regulations and are listed via the 510(k) pathway. Sturdy Industrial Co., Ltd. is based in the United States.
Catalogue
Sturdy Manual Resuscitator Ref K032596
Regimes: 510(k) Registry: 510(k)Sturdy Autoclave Super Microm Ref K231489
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
FDA establishments
- Sturdy Industrial Co., Ltd. NEW TAIPEI CITY · TW FEI 3007515605
Frequently asked questions
How many devices does Sturdy Industrial Co., Ltd. have in the registry?
The registry currently lists 3 devices for Sturdy Industrial Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Sturdy Industrial Co., Ltd.'s devices?
Among its 3 most recently registered devices, Sturdy Industrial Co., Ltd. has devices listed in FDA 510(k) (3 devices).
What risk classes do Sturdy Industrial Co., Ltd.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Sturdy Industrial Co., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Sturdy Industrial Co., Ltd. in the registry?
The most recently registered devices listed for Sturdy Industrial Co., Ltd. include STURDY MANUAL RESUSCITATOR, Sturdy Autoclave Super Microm and STURDY Autoclave Super Microm (models SA-260MA and SA-260MA-R).
Which FDA establishments are linked to Sturdy Industrial Co., Ltd.?
1 FDA establishment is linked to Sturdy Industrial Co., Ltd. in the registry; they are listed on the company page.