Tuttnauer Co., Ltd.
Country not established FDA
- Devices
- 10
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA establishment
What Tuttnauer Co., Ltd. makes
The company manufactures steam autoclaves for sterilizing medical and laboratory instruments, including pre-vacuum, automatic, and tabletop models. Products include the Pre-Vacuum Autoclave, American Gold Series, LSI series, and EZ Plus Series, designed for healthcare and research environments. Some models are specified for particular applications, such as the EHS Series for tabletop use.
These devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The company’s products are registered in the FDA’s 510(k) database. The manufacturer is based in the United States.
Catalogue
- 510(k) 510(k)
T-Edge 10, T-Edge 11 Ref K213080
510(k) 510(k)- 510(k) 510(k)
Tuttnauer Pre-Vacuum Autoclave Ref K850264
510(k) 510(k)American Gold Series Autoclave Ref K833837
510(k) 510(k)Tuttnauer Lsi (Automatic) Ref K920478
510(k) 510(k)- 510(k) 510(k)
- 510(k) 510(k)
- 510(k) 510(k)
- 510(k) 510(k)
FDA establishments
- Tuttnauer Ltd. BEIT SHEMESH Jerusalem · IL FEI 3005343391
Frequently asked questions
How many devices does Tuttnauer Co., Ltd. have in the registry?
The registry currently lists 10 devices for Tuttnauer Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Tuttnauer Co., Ltd.'s devices?
Among its 10 most recently registered devices, Tuttnauer Co., Ltd. has devices listed in FDA 510(k) (10 devices).
What risk classes do Tuttnauer Co., Ltd.'s devices fall under?
Among its 10 most recently registered devices, the classes recorded for Tuttnauer Co., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Tuttnauer Co., Ltd. in the registry?
The most recently registered devices listed for Tuttnauer Co., Ltd. include Tuttnauer Horizontal autoclave series model: 4472, 5596, 6690, 66120, T-Edge 10, T-Edge 11, Tuttnauer Pre-vacuum Steam Sterilizer models 3870HSG and 3870HSG-WS and TUTTNAUER PRE-VACUUM AUTOCLAVE.
Which FDA establishments are linked to Tuttnauer Co., Ltd.?
1 FDA establishment is linked to Tuttnauer Co., Ltd. in the registry; they are listed on the company page.