Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3021343245

FEI Number

3021343245

Entity Name

SHENZHEN CERTAINN TECHNOLOGY CO., LTD.

City/State/Country

Shenzhen Guangdong, CN

Establishment Address

L302, Bldg. 2, No.8 Tangtou 1st Road, Shenzhen Guangdong 518108, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

Shenzhen CERTAINN Technology Co., Ltd. (Owner Number: 10083554)

Owner / Operator Contact Address

L302, Bldg. 2, No.8 Tangtou 1st Road, Shenzhen, CN-GD 518108, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Auto Refractometer Keratometer Manual refractometer Corneal Topographer Handheld Auto Refractometer Digital Camera Unit Operating Microscope OPM500, OPM500C, OPM500D

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HKO	Refractometer, Ophthalmic	Ophthalmic	Class 1	886.1760	2021-12-01
MMQ	Topographer, Corneal, Ac-Powered	Ophthalmic	Class 1	886.1350	2025-07-16
HKN	Refractor, Manual, Non-Powered, Including Phoropter	Ophthalmic	Class 1	886.1770	2021-12-02
KQM	Camera, Surgical And Accessories	General, Plastic Surgery	Class 1	878.4160	2025-06-12
HRM	Microscope, Operating & Accessories, Ac-Powered, Ophthalmic	General, Plastic Surgery	Class 1	878.4700	2024-01-22

Official Correspondent

No official correspondent registered.

US Agent Details

Jessie Yao Business: MEDRIGHT TECH INC Email: info@medright-tech.com Phone: (718) 2169957

Related Public Records

Same Entity

Shenzhen CERTAINN 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 3021343245. Last updated year: 2026. Please use registration number 3021343245 when referencing this establishment in official correspondence.