Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013178978

FEI Number

3013178978

Entity Name

Guangdong Newdermo Biotech Co., Ltd

City/State/Country

Guangzhou Guangdong, CN

Establishment Address

Building 70(C28),No.9 Huateng Road,Jinshan Village,Shiqi Town, Panyu District, Guangzhou Guangdong 511450, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Guangdong Newdermo Biotech Co., Ltd (Owner Number: 10053680)

Owner / Operator Contact Address

Building 70 (C28), No.9 Huateng Road, Jinshan Village, Shiqi Town, Panyu District, Guangzhou, CN-GD 511450, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

LED Light Therapy Mask(FM-19K) FIRMAGLOW; FIRMAGLOW Body

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	2024-11-14
GED	Brush, Dermabrasion, Manual	General, Plastic Surgery	Class 1	878.4800	2026-01-13

Official Correspondent

Junyi Xing

US Agent Details

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

Related Public Records

Same Entity

Guangdong Newdermo 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 3013178978. Last updated year: 2026. Please use registration number 3013178978 when referencing this establishment in official correspondence.