FDA Device Entity Profile: HELENA LABORATORIES, CORP.

Known Identifiers & Locations

FEI Numbers 1000116989, 1618982, 2916657

Owner Operator Numbers 1618982

Locations Covered BEAUMONT, TX, US; PETALUMA, CA, US

Registered Establishments (3)

Registration #	Establishment Name	Location	Establishment Type(s)	Action
1618982	HELENA LABORATORIES, CORP.	BEAUMONT, TX, US	Manufacture Medical Device	View Details
1644474	HELENA LABORATORIES, CORP.	BEAUMONT, TX, US	Manufacture Device in the United States for Export Only	View Details
2916657	LABCON, NORTH AMERICA	PETALUMA, CA, US	Manufacture Medical Device for Another Party (Contract Manufacturer),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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