FDA Device Entity Profile: BIOTRONIK AG

Known Identifiers & Locations

FEI Numbers 3002808050, 3011574793, 3018805824

Owner Operator Numbers 10024585

Locations Covered BULACH Zurich, CH; Rostock-Warnemuende Mecklenburg-Western Pomerania, DE; Singapore South East, SG

Registered Establishments (3)

Registration #	Establishment Name	Location	Establishment Type(s)	Action
3011574793	CORTRONIK GmbH	Rostock-Warnemuende Mecklenburg-Western Pomerania, DE	Manufacture Medical Device for Another Party (Contract Manufacturer)	View Details
3018805824	BIOTRONIK APM PTE. LTD	Singapore South East, SG	Manufacture Medical Device for Another Party (Contract Manufacturer)	View Details
8043892	BIOTRONIK AG	BULACH Zurich, CH	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.

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