Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013340866

FEI Number

3013340866

Entity Name

OSSAWARE BIOTECH CO., LTD.

City/State/Country

Shenkang Hsiang Changhua, TW

Establishment Address

No. 51, Xinggong Rd.,, Shenkang Hsiang Changhua 50971, TW

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

OSSAWARE BIOTECH CO., LTD. (Owner Number: 10075919)

Owner / Operator Contact Address

No. 51, Xinggong Rd.,, Shenkang Hsiang, TW-CHA 50971, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

CUSMED FACE MASK

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2021-03-11

Official Correspondent

Meng Feng Huang

US Agent Details

JJ Wu Business: Cusmed Biotech LLC Email: FDA@CUSMED.COM Phone: (702) 6133699

Related Public Records

Same Entity

OSSAWARE BIOTECH 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 3013340866. Last updated year: 2026. Please use registration number 3013340866 when referencing this establishment in official correspondence.