FDA Device Entity Profile: ASAHI INTECC CO., LTD.

Known Identifiers & Locations

FEI Numbers 3003775027, 3003780911, 3004718255, 3009121749, 3016119728

Owner Operator Numbers 9051916

Locations Covered Amphur Muang Pathumthani Pathum Thani, TH; Hanoi Ha Noi, VN; Lapu-Lapu Cebu, PH; SETO Aichi, JP; Tustin, CA, US

Registered Establishments (5)

Registration #	Establishment Name	Location	Establishment Type(s)	Action
3003775027	ASAHI INTECC CO., LTD.	SETO Aichi, JP	Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device	View Details
3003780911	ASAHI INTECC (THAILAND) CO., LTD.	Amphur Muang Pathumthani Pathum Thani, TH	Manufacture Medical Device for Another Party (Contract Manufacturer)	View Details
3004718255	ASAHI INTECC USA, INC.	Tustin, CA, US	Develop Specifications But Do Not Manufacture At This Facility	View Details
3009121749	ASAHI INTECC HANOI CO., LTD.	Hanoi Ha Noi, VN	Manufacture Medical Device for Another Party (Contract Manufacturer)	View Details
3016119728	Toyoflex Cebu Corporation	Lapu-Lapu Cebu, PH	Manufacture Medical Device for Another Party (Contract Manufacturer)	View Details

510(k) Premarket Notifications (1)

Submission #	Device Name	Decision Date	Decision Description	Action
K150445	ASAHI Peripheral Guide Wire Series (ASAHI Gladius, ASAHI Halberd, ASAHI Gaia PV)	2015-06-30	Substantially Equivalent	View Details

FDA Recall History (0)

No recall records found for this entity.

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