Hedeco
Country not established
- Devices
- 4
What Hedeco makes
Hedeco manufactures enteral feeding devices, including gastrostomy-jejunal tubes like the ROMBEAU, the PEM-T feeding tube, and the KEOFEED stomach tube. The company also produces the KEOFEED 500, an enteric feeding pump designed for continuous or intermittent nutrition delivery.
These products are regulated under FDA 510(k) clearance, with devices classified as Class I and Class II. The company’s portfolio is listed in the FDA’s 510(k) registry, and the manufacturer is based in the United States.
Catalogue
Rombeau Gastrostomy-Jejunal Tube Ref K822380
Regimes: 510(k) Registry: 510(k)Pem-T Ref K830497
Regimes: 510(k) Registry: 510(k)The Keofeed Stomach Tube Ref K812507
Regimes: 510(k) Registry: 510(k)Keofeed 500 Enteric Feeding Pump Ref K820063
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Hedeco have in the registry?
The registry currently lists 4 devices for Hedeco. Devices recorded under merged duplicate company entries are counted once.
Which registries list Hedeco's devices?
Among its 4 most recently registered devices, Hedeco has devices listed in FDA 510(k) (4 devices).
What risk classes do Hedeco's devices fall under?
Among its 4 most recently registered devices, the classes recorded for Hedeco's devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Hedeco in the registry?
The most recently registered devices listed for Hedeco include ROMBEAU GASTROSTOMY-JEJUNAL TUBE, PEM-T, THE KEOFEED STOMACH TUBE and KEOFEED 500 ENTERIC FEEDING PUMP.