Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3029328624

FEI Number

3029328624

Entity Name

ZHENGZHOU ZHONGKEMEI HEALTH TECHNOLOGY CO., LTD.

City/State/Country

Shangjie District Henan, CN

Establishment Address

Room 928, 16th Floor, Unit 1,, Building 1, No. 33 Jinshuo Road, Shangjie District Henan 450000, CN

Establishment Type(s)

Foreign Private Label Distributor,Remanufacture Medical Device,Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

Zhengzhou Zhongkemei Health Technology Co., Ltd. (Owner Number: 10095064)

Owner / Operator Contact Address

Room 928, 16th Floor, Unit 1,, Building 1, No. 33 Jinshuo Road, Shangjie District, CN-HA 450000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Red light therapy device Hydrogen inhale machine

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ILY	Lamp, Infrared, Therapeutic Heating	Physical Medicine	Class 2	890.5500	2026-06-17
BYW	Device, Rebreathing	Anesthesiology	Class 1	868.5675	2026-01-20

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

Zhengzhou Zhongkemei Health 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 3029328624. Last updated year: 2026. Please use registration number 3029328624 when referencing this establishment in official correspondence.