FDA Device Entity Profile: Convatec, Inc.

Known Identifiers & Locations

FEI Numbers 1000477110, 3003442380, 3011987967

Owner Operator Numbers 8021535

Locations Covered OSTED, LEJRE Sjalland, DK; Reynosa Tamaulipas, MX

Registered Establishments (2)

Registration #	Establishment Name	Location	Establishment Type(s)	Action
3003442380	Unomedical Devices S.A de C.V	Reynosa Tamaulipas, MX	Manufacture Medical Device for Another Party (Contract Manufacturer)	View Details
8021545	UNOMEDICAL A/S	OSTED, LEJRE Sjalland, DK	Complaint File Establishment per 21 CFR 820.198,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 (1)

Recall #	Product Description	Initiation Date	Status	Action
Z-0013-2012	Natura Durahesive ConvaTec Moldable Technology Post-Operative /Surgical System (57 mm) Required for application to a patient immediately after ostomy surgery. Reason: Post-operative kits 57 mm may contain 70 mm pouches.	2011-06-22	Terminated	View Details

Profile Disclaimer

AvaSpecs compiles public data records from the FDA database. This compiled profile does not indicate endorsement, safety, clearance, approval, or compliance status. AvaSpecs is a private search index and is not affiliated with the FDA or any government agency.