Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3021544569

FEI Number

3021544569

Entity Name

FAIRY MEDICAL ELECTRICS(JIAXING)CO.,LTD

City/State/Country

Jiaxing Zhejiang, CN

Establishment Address

West zone of 2nd Floor, Building A, No.2 Caohejing RD. Haichang Street, Haining City, Jiaxing City, Zhejiang P, Jiaxing Zhejiang 314499, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Fairy Medical Electrics(Jiaxing)Co.,LTD (Owner Number: 10083861)

Owner / Operator Contact Address

West zone of 2nd Floor, Building A, No.2 Caohejing RD. Haichang Street, Haining City, Jiaxing City, Zhejiang Province, Jiaxing, CN-ZJ 314499, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

COL-R-AF01 CRUX FR10-FR02 CRUX FR10-FR06 CRUX FR10-FR08 CRUX FR10-FR03 CRUX FR10-FR04 CRUX FR10-FR05 CRUX 110i-SS01 CRUX FR10-FR09 CRUX FR10-FR01 CRUX FR10-FR10 CRUX FR10-FR07 COL-D-A01

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IZW	Collimator, Automatic, Radiographic	Radiology	Class 2	892.1610	2021-12-27
IZX	Collimator, Manual, Radiographic	Radiology	Class 2	892.1610	2021-12-27
KPW	Device, Beam Limiting, X-Ray, Diagnostic	Radiology	Class 2	892.1610	2024-12-17

Official Correspondent

Yuqi Lang

US Agent Details

Marco Mu Business: MID-LINK INTERNATIONAL CO., LTD Email: us.agent@mid-link.net Phone: (702) 2095185

Related Public Records

Same Entity

Fairy Medical Electrics(Jiaxing)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 3021544569. Last updated year: 2026. Please use registration number 3021544569 when referencing this establishment in official correspondence.