Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015139810

FEI Number

3015139810

Entity Name

SHENZHEN AIRGLE CORPORATION LIMITED

City/State/Country

Shenzhen Guangdong, CN

Establishment Address

Zone A&B, The 11th Floor, KeChuang Building, QuanZhi Science & Technology Innovation Park, Houting Maozhoushan Industrial Park, ShaJing Street, Baoan District, Shenzhen Guangdong 518000, CN

Establishment Type(s)

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

Owner / Operator

SHENZHEN AIRGLE CORPORATION LIMITED (Owner Number: 10059006)

Owner / Operator Contact Address

Zone A&B, The 11th Floor, KeChuang Building, QuanZhi Science & Technology Innovation Park, Houting Maozhoushan Industrial Park,ShaJing Street, Baoan District, Shenzhen, CN-GD 518000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Airgle Room Air Purifier, Models: AG300, AG300S, AG300L, AG300E, AG320, AG320S, AG320L, AG320E Airgle Clean Room Air Purifier, Models: AG900, AG900S, AG900L, AG900E, AG930, AG930S, AG930L, AG930E Airgle Room Air Purifier, Models: AG600, AG600S, AG600L, AG600E, AG700, AG700S, AG700L, AG700E Airgle Face Mask, Models: AM120, AM120M, AM120W, AM120B, AM120G, AM100, AM100S, AM100M, AM100L Airgle Extraoral Dental Smart FlexHose, Models: AG600D, AG900D

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FRA	Purifier, Air, Ultraviolet, Medical	General Hospital	Class 2	880.6500	2026-03-05
BSJ	Mask, Gas, Anesthetic	Anesthesiology	Class 1	868.5550	2018-12-05
GDR	Saw, Manual And Accessories	General, Plastic Surgery	Class 1	878.4800	2020-12-24

Official Correspondent

Jerry Liu

US Agent Details

Jeff Liu Email: jerry@airgle.com.cn Phone: (917) 3997708

Related Public Records

Same Entity

SHENZHEN AIRGLE CORPORATION LIMITED

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 3015139810. Last updated year: 2026. Please use registration number 3015139810 when referencing this establishment in official correspondence.