FDA Device Entity Profile: Epredia Holdings Ltd.

Known Identifiers & Locations

FEI Numbers 1219230, 1831638, 3003584784, 3005642384, 3011631044

Owner Operator Numbers 10062642

Locations Covered Duiven Gelderland, NL; KALAMAZOO, MI, US; Portsmouth, NH, US; RUNCORN Cheshire East, GB; SHANGHAI, CN

Registered Establishments (5)

Registration #	Establishment Name	Location	Establishment Type(s)	Action
1219230	NEW ERIE SCIENTIFIC LLC	Portsmouth, NH, US	Manufacture Medical Device,Complaint File Establishment per 21 CFR 820.198	View Details
1831638	RICHARD-ALLAN SCIENTIFIC LLC	KALAMAZOO, MI, US	Manufacture Medical Device	View Details
3003584784	SHANDON DIAGNOSTICS LIMITED	RUNCORN Cheshire East, GB	Manufacture Medical Device	View Details
3005642384	Epredia Laboratory Products Manufacturing (Shanghai) Co., Ltd	SHANGHAI, CN	Manufacture Medical Device for Another Party (Contract Manufacturer)	View Details
3011631044	FA-Tech Diagnostics Europe BV	Duiven Gelderland, NL	Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)	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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