FDA Device Entity Profile: Sirtex Medical Inc.

Known Identifiers & Locations

FEI Numbers 3005579300, 3009088444, 3012690638, 3013070673

Owner Operator Numbers 9047689

Locations Covered Frankfurt am Main Hesse, DE; Singapore Central Singapore, SG; Wilmington, MA, US; Woburn, MA, US

Registered Establishments (4)

Registration #	Establishment Name	Location	Establishment Type(s)	Action
3005579300	Sirtex Wilmington LLC	Wilmington, MA, US	Repack or Relabel Medical Device	View Details
3009088444	Sirtex Singapore Manufacturing Pte Ltd	Singapore Central Singapore, SG	Repack or Relabel Medical Device	View Details
3012690638	SIRTEX MEDICAL INC.	Woburn, MA, US	Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility	View Details
3013070673	Sirtex Germany Manufacturing GmbH	Frankfurt am Main Hesse, DE	Repack or Relabel Medical Device,Manufacture Medical Device	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.

Profile Disclaimer

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