Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005321947

FEI Number

3005321947

Entity Name

HANA MICROELECTRONICS PUBLIC CO.,LTD.

City/State/Country

A. Muang Lamphun, TH

Establishment Address

101/2 Moo. 4, T.Banklang, A. Muang Lamphun 51000, TH

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Hana Microelectronics Public Co.,Ltd. (Owner Number: 10049943)

Owner / Operator Contact Address

101/2 Moo. 4, T.Banklang, A. Muang, TH-51 51000, TH

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Tempdrop Hailie Sensor (NF0110 ProAir HFA) Tala Engage, Engage Rechargeable, FIO

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	2021-12-01
LHD	Device, Fertility Diagnostic, Proceptive	Unknown	Class U	N/A	2016-05-23
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2021-12-01
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2023-09-27
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2019-02-27
QUG	Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter	Ear, Nose, Throat	Class 2	874.3305	2023-07-09
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2022-11-27

Official Correspondent

TIPAWAN DUANGKAEW

US Agent Details

Thang Bui Business: Senior Director of Sales and Business Development Email: thang_bui@hanaus.com Phone: (949) 3313363

Related Public Records

Same Entity

Hana Microelectronics Public 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

Registration Number	Establishment Name	Location
1110315	MYLAN PHARMACEUTICALS INC.	Morgantown, WV, US
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 3005321947. Last updated year: 2026. Please use registration number 3005321947 when referencing this establishment in official correspondence.