NIHON KOHDEN CORP.

Entity profile compiled from public source records

Public Record Profile Registrations: 11 510(k) filings: 0 Recalls: 0

Known Identifiers & Locations

FEI Numbers 2080783, 3002807720, 3002807739, 3003142870, 3007481893, 3007962724, 3013501110, 3016852448, 3021736577, 3030154814, 3030516450
Owner Operator Numbers 8030227
Locations Covered Foothill Ranch, CA, US; Fukaya-Shi Saitama, JP; Gunma Tokyo, JP; Hachioji-shi Tokyo, JP; Honjo-shi Saitama, JP; IRVINE, CA, US; Irvine, CA, US; SHINJUKU-KU Tokyo, JP; Sakado City Saitama, JP; TOMIOKA-SHI Gunma, JP; Tokorozawa Saitama, JP

Registered Establishments (11)

Registration # Establishment Name Location Establishment Type(s) Action
2032233 Nihon Kohden Digital Health Solutions, LLC. IRVINE, CA, US Manufacture Medical Device View Details
2080783 NIHON KOHDEN AMERICA, INC. Irvine, CA, US Complaint File Establishment per 21 CFR 820.198 View Details
3007481893 Nihon Kohden Tomioka Corporation Nihon Kohden Kawamoto Production Center Fukaya-Shi Saitama, JP Manufacture Medical Device View Details
3007962724 Nihon Kohden Tomioka Corporation Gunma Tokyo, JP Manufacture Medical Device View Details
3013501110 Nihon Kohden Corporation - Tokorozawa establishment Advanced Technology Center Tokorozawa Saitama, JP Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility View Details
3016852448 Nihon Kohden Corporation - Eastern Japan Logistics Center Sakado City Saitama, JP Export Device to the United States But Perform No Other Operation on Device View Details
3021736577 Nihon Vinyl Cord Corporation - Kodama Second Factory Honjo-shi Saitama, JP Manufacture Medical Device View Details
3030154814 Nihon Kohden America Fulfillment Center Foothill Ranch, CA, US Manufacture Medical Device View Details
3030516450 Nihon Vinyl Cord Corporation - Shimo-ongata Factory Hachioji-shi Tokyo, JP Manufacture Medical Device for Another Party (Contract Manufacturer) View Details
8030229 NIHON KOHDEN TOMIOKA PRODUCTION CENTER TOMIOKA-SHI Gunma, JP Manufacture Medical Device View Details
9611252 NIHON KOHDEN CORP. SHINJUKU-KU Tokyo, JP 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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