FDA Device Entity Profile: ATEX Co., Ltd.

Known Identifiers & Locations

FEI Numbers 3006644662, 3014133483

Owner Operator Numbers 10060111, 9105439

Locations Covered Osaka, JP; Paju-Si Gyeonggi, KR

Registered Establishments (2)

Registration #	Establishment Name	Location	Establishment Type(s)	Action
3006644662	ATEX CO., LTD.	Paju-Si Gyeonggi, KR	Manufacture Medical Device	View Details
3014133483	ATEX CO., LTD.	Osaka, JP	Sterilize Medical Device for Another Party (Contract Sterilizer),Develop Specifications But Do Not Manufacture At This Facility,Complaint File Establishment per 21 CFR 820.198,Remanufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer),Reprocess Single-Use Device,Repack or Relabel Medical Device,Foreign Private Label Distributor,Manufacture Medical Device,Export Device to the United States But Perform No Other Operation on 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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