Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015077448

FEI Number

3015077448

Entity Name

Oneness Biotech Co., Ltd.

City/State/Country

Pingtung County, TW

Establishment Address

No.8, Tangchang Rd., Nanchou Township, Pingtung County 926, TW

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

Oneness Biotech Co., Ltd (Owner Number: 10087222)

Owner / Operator Contact Address

35F, No. 66, Sec. 1, Zhongxiao W. Rd., Zhongzheng Dist., Taipei City, TW-TPE 100, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K251093

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2024-07-10
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2023-01-31
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2025-06-11

Official Correspondent

Angel Hsieh

US Agent Details

Shuling Cheng Business: Oneness USA Co., Ltd. Email: md.regulatory@onenessbio.com.tw Phone: (626) 6462457

Related Public Records

Same Entity

Oneness Biotech 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
K150256	Argentum Medical	SILVERLON BURN CONTACT DRESSINGS	2015-04-30

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-06	B. Braun Medical, Inc.	U	D-Stat Dry Hemostatic Bandage. The product is an adhesive bandage.
Z-0038-2025	3M Company Health Care Business 3m Center	U	3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015077448. Last updated year: 2026. Please use registration number 3015077448 when referencing this establishment in official correspondence.