HOYA Corporation PENTAX Division

Entity profile compiled from public source records

Public Record Profile Registrations: 6 510(k) filings: 0 Recalls: 0

Known Identifiers & Locations

FEI Numbers 1000080301, 3003782610, 3008185830, 3012414760, 3014605202, 3033588952
Owner Operator Numbers 8030235
Locations Covered Akishima-shi Tokyo, JP; KURIHARA-SHI Miyagi, JP; MONTVALE, NJ, US; Mississauga Ontario, CA; Penang Pulau Pinang, MY; Plovdiv, BG

Registered Establishments (6)

Registration # Establishment Name Location Establishment Type(s) Action
2518897 PENTAX of America, Inc. MONTVALE, NJ, US Complaint File Establishment per 21 CFR 820.198 View Details
3003782610 HOYA Corporation PENTAX Lifecare Division KURIHARA-SHI Miyagi, JP Manufacture Medical Device,Export Device to the United States But Perform No Other Operation on Device View Details
3012414760 Pentax Medical Mississauga Ontario, CA Remanufacture Medical Device View Details
3014605202 PENTAX MEDICAL (PENANG) SDN. BHD. Penang Pulau Pinang, MY Export Device to the United States But Perform No Other Operation on Device View Details
3033588952 HOYA Corporation Plovdiv, BG Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device View Details
9610877 HOYA Corporation PENTAX Lifecare Division Akishima-shi Tokyo, JP Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility 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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