Unoplast A/S
Country not established
- Devices
- 7
What Unoplast A/S makes
Unoplast A/S manufactures single-use medical devices including nasogastric and orogastric feeding tubes, suction catheters (straight and coudé), Nelaton and Tiemann catheters, oxygen catheters, and a vacuum-assisted drainage device (VACCON). The company also produces the UNOMETER 500, a device for measuring oxygen flow, and the DISARP Original, a disposable suction device.
The portfolio includes Class I and Class II devices, with several authorised via the FDA’s 510(k) pathway. Products are listed under U.S. regulatory frameworks, and the company operates from the United States.
Catalogue
Unometer 500 Ref K896732
510(k) 510(k)Disarp Original Ref K802248
510(k) 510(k)Feeding Tube Ref K896734
510(k) 510(k)Nelaton-, Female - Or Tiemann Catheter Ref K896729
510(k) 510(k)Oxygen Catheters Ref K896731
510(k) 510(k)Suction Catheter Straight/Coude Ref K896730
510(k) 510(k)Vaccon Ref K896733
510(k) 510(k)
Frequently asked questions
How many devices does Unoplast A/S have in the registry?
The registry currently lists 7 devices for Unoplast A/S. Devices recorded under merged duplicate company entries are counted once.
Which registries list Unoplast A/S's devices?
Among its 7 most recently registered devices, Unoplast A/S has devices listed in FDA 510(k) (7 devices).
What risk classes do Unoplast A/S's devices fall under?
Among its 7 most recently registered devices, the classes recorded for Unoplast A/S's devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Unoplast A/S in the registry?
The most recently registered devices listed for Unoplast A/S include UNOMETER 500, DISARP ORIGINAL, FEEDING TUBE and NELATON-, FEMALE - OR TIEMANN CATHETER.