Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3032723136

FEI Number

3032723136

Entity Name

ZHUHAI NIRAY PHOTON TECHNOLOGY CO., LTD.

City/State/Country

Zhuhai Guangdong, CN

Establishment Address

5F, Building 5, No.66, Keji 1st Road,, Tangjiawan Town, High-tech Zone, Zhuhai Guangdong 519080, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

Zhuhai Niray Photon Technology Co., Ltd. (Owner Number: 10094509)

Owner / Operator Contact Address

5F, Building 5, No.66, Keji 1st Road,, Tangjiawan Town, High-tech Zone, Zhuhai, CN-GD 519080, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Medical Diagnostic Rotating Anode X-ray Tube(NRX350); Medical Diagnostic Rotating Anode X-ray Diagnostic Rotating Anode X-ray Tube(NiceRay3887); Medical Diagnostic Rotating Anode X-ray Assembly(NiceRayX200); Medical Diagnostic X-Ray Tube Assembly(NiceRayX490). Medical CT X-Ray Tube Assembly(NiceRayX600); Medical CT X-Ray Tube Assembly(NiceRayX880); Medical CT X-Ray Tube Assembly(NiceRayX350A); Medical CT X-Ray Tube Assembly(NiceRayX1735); Tube(NiceRay750D); Medical Diagnostic Rotating Anode X-ray Tube(NiceRay700); Medical Tube(NiceRay2150); Medical Diagnostic Rotating Anode X-ray Tube(NiceRay3071); Medical Tube(NiceRay000); Medical Diagnostic Rotating Anode X-ray Tube(NiceRay500B); Medical Tube(NiceRay350A); Medical Diagnostic Rotating Anode X-ray Tube(NiceRay1735); Medical Medical CT X-Ray Tube Assembly(NRH350); Medical CT X-Ray Tube Assembly(NiceRayX422); Tube(NiceRay422); Medical Diagnostic Rotating Anode X-ray Tube(NiceRay600); Medical Diagnostic Rotating Anode X-ray Tube(NiceRay200); Medical Diagnostic Rotating Anode X-ray Tube(NiceRay490); Medical CT X-Ray Tube Assembly(NiceRayX3887); Medical CT X-Ray Tube Assembly(NiceRayX000); Diagnostic Rotating Anode X-ray Tube(NiceRay135); Medical Diagnostic Rotating Anode X-ray Diagnostic Rotating Anode X-ray Tube(NiceRay750G); Medical Diagnostic Rotating Anode X-ray Diagnostic Rotating Anode X-ray Tube(NiceRay1740); Medical Diagnostic Rotating Anode X-ray Medical CT X-Ray Tube Assembly(NiceRayX500B); Medical CT X-Ray Tube Assembly(NiceRayX135); Medical CT X-Ray Tube Assembly(NiceRayX165); Medical CT X-Ray Tube Assembly(NiceRayX400C); Medical CT X-Ray Tube Assembly(NiceRayX1740); Medical CT X-Ray Tube Assembly(NiceRayX2150); Tube(NiceRay165); Medical Diagnostic Rotating Anode X-ray Tube(NiceRay160); Medical Diagnostic Medical Diagnostic X-Ray Tube Assembly(NiceRayX160); Medical Diagnostic X-Ray Tube Medical CT X-Ray Tube Assembly(NiceRayX750D); Medical CT X-Ray Tube Assembly(NiceRayX700); Medical CT X-Ray Tube Assembly(NiceRayX3071); Medical CT X-Ray Tube Assembly(NiceRayX750G); Rotating Anode X-ray Tube(NiceRay880); Medical Diagnostic Rotating Anode X-ray

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ITY	Assembly, Tube Housing, X-Ray, Diagnostic	Radiology	Class 1	892.1760	2025-12-04

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar corp Email: David.Lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

Zhuhai Niray Photon Technology Co., Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3032723136. Last updated year: 2026. Please use registration number 3032723136 when referencing this establishment in official correspondence.