FDA Device Entity Profile: TERUMO MEDICAL CORP.

Known Identifiers & Locations

FEI Numbers 1118880, 2243441, 3008307705, 3013394970

Owner Operator Numbers 9003933

Locations Covered Caguas, PR, US; ELKTON, MD, US; Somerset, NJ, US; Vaughan Ontario, CA

Registered Establishments (4)

Registration #	Establishment Name	Location	Establishment Type(s)	Action
1118880	TERUMO MEDICAL CORP.	ELKTON, MD, US	Manufacture Device in the United States for Export Only,Manufacture Medical Device	View Details
2243441	TERUMO MEDICAL CORP.	Somerset, NJ, US	Manufacture Device in the United States for Export Only	View Details
3008307705	Terumo Medical Canada, Inc.	Vaughan Ontario, CA	Export Device to the United States But Perform No Other Operation on Device	View Details
3013394970	Terumo Puerto Rico LLC	Caguas, PR, US	Manufacture Medical Device for Another Party (Contract Manufacturer)	View Details

510(k) Premarket Notifications (2)

Submission #	Device Name	Decision Date	Decision Description	Action
K003571	SERONO FOR USE WITH GONAL-F 1200IU MULTI-DOSE ONLY AT 600IU/ML SYRINGE	2001-02-12	Substantially Equivalent	View Details
K850376	TERUMO SENSIBEAD EIA TSH KIT	1985-03-04	Substantially Equivalent	View Details

FDA Recall History (0)

No recall records found for this entity.

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