FDA Device Entity Profile: SB-KAWASUMI LABORATORIES, INC.

Known Identifiers & Locations

FEI Numbers 1000113359, 3002806337, 3003282181, 3010141954

Owner Operator Numbers 8031539

Locations Covered Akita, JP; CHOK CHAI Nakhon Ratchasima, TH; Dongguan Guangdong, CN; Tampa, FL, US

Registered Establishments (4)

Registration #	Establishment Name	Location	Establishment Type(s)	Action
1055927	KAWASUMI LABORATORIES AMERICA, INC.	Tampa, FL, US	Complaint File Establishment per 21 CFR 820.198	View Details
3002806337	Akita Sumitomo Bakelite Co., Ltd.	Akita, JP	Manufacture Medical Device for Another Party (Contract Manufacturer)	View Details
3010141954	Sumitomo Bakelite (Dongguan) Co., Ltd.	Dongguan Guangdong, CN	Sterilize Medical Device for Another Party (Contract Sterilizer),Manufacture Medical Device for Another Party (Contract Manufacturer)	View Details
9615908	KAWASUMI LABORATORIES (THAILAND) CO., LTD.	CHOK CHAI Nakhon Ratchasima, TH	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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