Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014656175

FEI Number

3014656175

Entity Name

ZOOMAX TECHNOLOGY CO., LIMITED

City/State/Country

Hangzhou Zhejiang, CN

Establishment Address

9F, Building D, Paradise Software Park, No.3 Xidoumen Road, Hangzhou Zhejiang 310012, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Sterilize Medical Device for Another Party (Contract Sterilizer),Remanufacture Medical Device,Reprocess Single-Use Device,Foreign Private Label Distributor,Complaint File Establishment per 21 CFR 820.198,Repack or Relabel Medical Device

Owner / Operator

ZOOMAX TECHNOLOGY CO., LIMITED (Owner Number: 10058836)

Owner / Operator Contact Address

9F, Building D, Paradise Software Park, No.3 Xidoumen Road, Hangzhou, CN-ZJ 310012, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Zoomax Luna 6 Zoomax Snow Pad Zoomax Snow 12 Zoomax Luna EYE Zoomax Snow Eye Zoomax Luna HD 24 Pro Insert Earphones Zoomax Luna 8 Zoomax Luna 6 Zoomax Snow 12 Zoomax Snow Eye Zoomax Luna S Zoomax Snow Pad Zoomax Luna Eye Zoomax Acesight VR Zoomax Luna HD 24 Pro Zoomax Luna S Zoomax Snow Pad Zoomax Luna 8

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HJG	System, Reading, Television, Closed-Circuit	Ophthalmic	Class 1	886.5820	2018-11-29
HOI	Spectacle, Magnifying	Ophthalmic	Class 1	886.5840	2018-11-01
EWO	Audiometer	Ear, Nose, Throat	Class 2	874.1050	2025-04-23
HPG	Aid, Vision, Electronic, Battery-Powered	Ophthalmic	Class 1	886.5900	2018-12-10
HJF	Magnifier, Hand-Held, Low-Vision	Ophthalmic	Class 1	886.5540	2018-11-01

Official Correspondent

Stella Shen

US Agent Details

Rebecca Chen Business: Zoomax USA Inc. Email: info@zoomaxusa.com Phone: (339) 8008033

Related Public Records

Same Entity

ZOOMAX TECHNOLOGY CO., LIMITED

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K920069	Innoventions, Inc.	MAGNI-CAM	1992-03-02
K780270	Maico Hearing Instruments, Inc.	COMPUTER AUDIOMETER - MA26	1978-02-27
K923074	Life-Tech Intl., Inc.	DANPLEX SCREENING AUDIOMETER	1992-09-23

Similar Registrations

Registration Number	Establishment Name	Location
3011587055	SHAOXING UNDIS MEDICAL TECHNOLOGY COMPANY LIMITED	Shaoxing Zhejiang, CN
3003032840	ACULA TECHNOLOGY CORP	Luchu Taoyuan, TW
3011898560	BEIJING HONGDEE CORPORATION	Beijing, CN
3009840810	REHAN ELECTRONICS	Carnew Wexford, IE
1123650	FREEDOM SCIENTIFIC BLV GROUP, LLC.	Clearwater, FL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014656175. Last updated year: 2026. Please use registration number 3014656175 when referencing this establishment in official correspondence.