Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016750005

FEI Number

3016750005

Entity Name

HCMED INNOVATIONS CO., LTD.

City/State/Country

New Taipei City, TW

Establishment Address

2F., No.166, Jiankang Rd., Zhonghe Dist., New Taipei City 23585, TW

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Repack or Relabel Medical Device,Manufacture Medical Device

Owner / Operator

HCMed Innovations Co., Ltd. (Owner Number: 10082903)

Owner / Operator Contact Address

Rm.B, 10F, No.319, Sec.2, Dunhua S. Rd., Da-an District, Taipei City, TW-TPE 10669, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K202171

PMA Number

N/A

All Registered Proprietary Names

Aerogen Go® Mask (Pediatric) Aerogen Go® Mask (Adult) AdheResp Pulmogine® Aerogen Go Vibrating Mesh Nebulizer Aerogen Go Medication Reservoir Aerogen Go Vibrating Mesh Nebulizer, Aerogen Go® Mask (Adult), Aerogen Go® Mask (Pediatric), Aerogen Go® Mouthpiece Aerogen Go AC/DC Adapter

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BYG	Mask, Oxygen	Anesthesiology	Class 1	868.5580	2025-12-22
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2025-12-23
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2021-10-19

Official Correspondent

Michelle Pieh

US Agent Details

Ho Shan Wang Email: acmebiotechs@gmail.com Phone: (623) 9864377

Related Public Records

Same Entity

HCMed Innovations 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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016750005. Last updated year: 2026. Please use registration number 3016750005 when referencing this establishment in official correspondence.