Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016734135

FEI Number

3016734135

Entity Name

TAIWAN COMFORT CHAMP MANUFACTURING CO., LTD.

City/State/Country

Taoyuan City, TW

Establishment Address

No. 55, Aly. 51, Ln. 50, Daren Rd., Taoyuan Dist., Taoyuan City 330058, TW

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

TAIWAN COMFORT CHAMP MANUFACTURING Co., LTD. (Owner Number: 10068241)

Owner / Operator Contact Address

No. 55, Aly. 51, Ln. 50, Daren Rd., Taoyuan Dist.,, Taoyuan City, TW-TAO 330058, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Face Mask Uneed Pleated Activated Carbon Mask Uneed Pleated Mask Craftsman Flat-Fold Stretch Activated Carbon Mask Face Masks Taiwan Champ 3D Face Mask (Flexible) Uneed Flat-Fold Stretch Activated Carbon Mask Uneed Flat-Fold Stretch Mask Craftsman Pleated Mask Craftsman Flat-Fold Stretch Mask Craftsman Pleated Activated Carbon Mask Taiwan Champ Medical Face Mask

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QKR	Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua	Unknown	Class N	N/A	2020-11-23
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2020-04-08

Official Correspondent

Ula Ho

US Agent Details

Matt Dryden Business: Promedic, LLC. Email: matt.dryden@promedic.cc Phone: (239) 3076060

Related Public Records

Same Entity

TAIWAN COMFORT CHAMP MANUFACTURING 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 3016734135. Last updated year: 2026. Please use registration number 3016734135 when referencing this establishment in official correspondence.