Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011189029

FEI Number

3011189029

Entity Name

DONGGUAN AIDISY MACHINERY & ELECTRONIC EQUIPMENT CO., LTD.

City/State/Country

Dongguan Guangdong, CN

Establishment Address

Part B,3rd F, Block A, Wentang Industrial Park,Longhua Road,Zhouwu Dongcheng District, Dongguan City,Guangdong Province,523000, P.R.China., Dongguan Guangdong 523000, CN

Establishment Type(s)

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

Owner / Operator

Dongguan Aidisy Machinery & Electronic Equipment Co., Ltd. (Owner Number: 10047031)

Owner / Operator Contact Address

Part B,3rd F, Block A, Wentang Industrial Park,Longhua Road,Zhouwu Dongcheng District, Dongguan City,Guangdong Province,523000, P.R.China., Dongguan, CN-GD 523000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K123030

PMA Number

N/A

All Registered Proprietary Names

NEBULIZER Clever Choice PMI Probasics Nebulizer

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2014-06-16

Official Correspondent

Jianjun Wang

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

Dongguan Aidisy Machinery & Electronic Equipment Co., Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K163485	Adherium (Nz), Ltd.	SmartTouch	2017-08-30
K781467	Travenol Laboratories, S.A.	U-FLOAT VALVE 2D9023	1978-09-07

Similar Registrations

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3018783526	CEVA LOGISTICS NETHERLANDS BV (Venray)	Oostrum Limburgh, NL
3005998497	SUNMED AP, LTD.	ZHUHAI Guangdong, CN
3006852037	Omron Healthcare Manufacturing Vietnam Co., Ltd.	Ho Chi Minh City, VN
3006783791	GaleMed (Xiamen) Co., Ltd.	XIAMEN Fujian, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011189029. Last updated year: 2026. Please use registration number 3011189029 when referencing this establishment in official correspondence.