Tuta Healthcare Pty Limited
AustraliaFDA applicant, unverified
- Devices
- 3
What Tuta Healthcare Pty Limited makes
Tuta Healthcare manufactures single-use medical devices for fluid administration and arthroscopic procedures, including a 150 mL burette for inline use, an arthroscopy flushing set, and blood/solution administration sets with specific model identifiers. These products are designed for controlled fluid delivery in surgical and diagnostic settings, ensuring compatibility with sterile procedures.
The company’s portfolio consists of Class II devices, which require premarket notification (510(k)) clearance under FDA regulations. These products are listed in the FDA’s 510(k) database, adhering to U.S. medical device authorization requirements. The manufacturer operates from the United States.
Catalogue
Burette-In Line (150 Ml) Ref K023595
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Blood/Solution Administration Set, Model 33.015 Ref K023039
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Tuta Healthcare Pty Limited have in the registry?
The registry currently lists 3 devices for Tuta Healthcare Pty Limited. Devices recorded under merged duplicate company entries are counted once.
Which registries list Tuta Healthcare Pty Limited's devices?
Among its 3 most recently registered devices, Tuta Healthcare Pty Limited has devices listed in FDA 510(k) (3 devices).
What risk classes do Tuta Healthcare Pty Limited's devices fall under?
Among its 3 most recently registered devices, the classes recorded for Tuta Healthcare Pty Limited's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Tuta Healthcare Pty Limited in the registry?
The most recently registered devices listed for Tuta Healthcare Pty Limited include BURETTE-IN LINE (150 ML), TUTA HEALTHCARE ARTHROSCOPY FLUSHING SET, MODEL 80.601 and BLOOD/SOLUTION ADMINISTRATION SET, MODEL 33.015.