FDA Device Entity Profile: JenaValve Technology, Inc.

Known Identifiers & Locations

FEI Numbers 3011894841, 3012148004

Owner Operator Numbers 10051384

Locations Covered Irvine, CA, US; Swillington Leeds, GB

Registered Establishments (2)

Registration #	Establishment Name	Location	Establishment Type(s)	Action
3011894841	JenaValve Production Limited	Swillington Leeds, GB	Manufacture Medical Device	View Details
3012148004	JENAVALVE TECHNOLOGY, INC.	Irvine, CA, US	Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device,Develop Specifications But Do Not Manufacture At This Facility	View Details

510(k) Premarket Notifications (0)

No 510(k) notifications found for this entity.

FDA Recall History (0)

No recall records found for this entity.

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