Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3029084259

FEI Number

3029084259

Entity Name

FIO INTERNATIONAL CO.,LTD

City/State/Country

Seo-gu Incheon, KR

Establishment Address

Suite 301-302, 11, Cheongna canal-ro 260beon-gil, Seo-gu Incheon 22762, KR

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

FIO INTERNATIONAL CO.,LTD (Owner Number: 10089922)

Owner / Operator Contact Address

Suite 301-302, 11, Cheongna canal-ro 260beon-gil, Seo-gu, KR-28 22762, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Pimple patch

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2024-01-22

Official Correspondent

No official correspondent registered.

US Agent Details

David Hyun Jun Paek Email: dpaek.rennes@gmail.com Phone: (818) 9030660

Related Public Records

Same Entity

FIO INTERNATIONAL 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 3029084259. Last updated year: 2026. Please use registration number 3029084259 when referencing this establishment in official correspondence.