Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3042158718

FEI Number

3042158718

Entity Name

OPENPATCH INC.

City/State/Country

Taipei, TW

Establishment Address

11 F.-1, No. 24, Sec. 4, Xinyi Rd., Da'an Dist., Taipei 106, TW

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

OpenPatch Inc. (Owner Number: 10094030)

Owner / Operator Contact Address

9F., No. 86-2, Yiwen 1st St., Taoyuan Dist., Taoyuan, TW-TAO 330007, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

OpenPatch Super Vi Hydrogel Wound Dressing (Sterile) OpenPatch Super Vi Red Light Medical Adhesive Patch (Non-Sterile) OpenPatch Super Vi Sting Free Adhesive Remover (Non-Sterile)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NAE	Dressing, Wound, Hydrogel Without Drug And/Or Biologic	General, Plastic Surgery	Class 1	878.4022	2025-11-17
FPX	Strip, Adhesive, Closure, Skin	General Hospital	Class 1	880.5240	2025-11-17
KOY	Degreaser, Skin, Surgical	General, Plastic Surgery	Class 1	878.4730	2025-11-17

Official Correspondent

Janice Chen

US Agent Details

Wen Wang Business: Willow Glen Consultancy LLC Email: Wen.Wang@WillowGlenFDA.com Phone: (619) 8690249

Related Public Records

Same Entity

OpenPatch Inc.

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 3042158718. Last updated year: 2026. Please use registration number 3042158718 when referencing this establishment in official correspondence.