Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3033813891

FEI Number

3033813891

Entity Name

ZHENGZHOU MAGIQUE HUAER BIOTECH CO.,LTD.

City/State/Country

Zhengzhou Henan, CN

Establishment Address

5th Floor,Block D,Building 18,Henan International University Science Park,, Zhengzhou Henan 450001, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Zhengzhou Magique Huaer Biotech Co.,Ltd. (Owner Number: 10091602)

Owner / Operator Contact Address

5th Floor,Block D,Building 18,Henan International University Science Park,, Zhengzhou, CN-HA 450001, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Micro needling therapy system Oxygen Dome Facial Machine

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GDF	Guide, Needle, Surgical	General, Plastic Surgery	Class 1	878.4800	2024-10-18
MNE	Orthosis, Moldable, Supportive, Skin Protective	Physical Medicine	Class 1	890.3475	2025-04-24

Official Correspondent

Kaihui Wang

US Agent Details

hui hong Business: ABMED MEDICAL TECHNOLOGY INC Email: info@abmed.us Phone: (509) 5816099

Related Public Records

Same Entity

Zhengzhou Magique Huaer Biotech 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 3033813891. Last updated year: 2026. Please use registration number 3033813891 when referencing this establishment in official correspondence.