FDA Device Entity Profile: Fujirebio Diagnostics, Inc.

Known Identifiers & Locations

FEI Numbers 1643621, 2521625, 3000125561, 3002608770, 3002895169, 3014643041, 3027273565

Owner Operator Numbers 10022860

Locations Covered GHENT Oost-Vlaanderen, BE; Gothenburg Vastra Gotaland, SE; Malvern, PA, US; Molndal Vastra Gotaland, SE; Sagamihara-shi Kanagawa, JP; Seguin, TX, US; Yamaguchi, JP

Registered Establishments (7)

Registration #	Establishment Name	Location	Establishment Type(s)	Action
1643621	Fujirebio Diagnostics, Inc.	Seguin, TX, US	Manufacture Medical Device	View Details
2521625	Fujirebio Diagnostics, Inc.	Malvern, PA, US	Manufacture Medical Device for Another Party (Contract Manufacturer)	View Details
3000125561	Fujirebio Diagnostics, AB	Gothenburg Vastra Gotaland, SE	Manufacture Medical Device	View Details
3002895169	Fujirebio Inc.	Sagamihara-shi Kanagawa, JP	Manufacture Medical Device	View Details
3014643041	Fujirebio Inc. Ube Facility	Yamaguchi, JP	Manufacture Medical Device	View Details
3027273565	Fujirebio Diagnostics AB	Molndal Vastra Gotaland, SE	Manufacture Medical Device	View Details
9615837	Fujirebio Europe N.V.	GHENT Oost-Vlaanderen, BE	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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