Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010201636

FEI Number

3010201636

Entity Name

WOOJEON CO.

City/State/Country

Gunpo-si Gyeonggi, KR

Establishment Address

2F, 3F, 85-22, Sanbon-ro,, Gunpo-si Gyeonggi 435-832, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

WOOJEON COMPANY (Owner Number: 10042693)

Owner / Operator Contact Address

2F, 3F, 85-22, Sanbon-ro,, Gunpo-si, KR-41 15849, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K111392

PMA Number

N/A

All Registered Proprietary Names

WOOJEON ACUPUNCTURE NEEDLE

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MQX	Needle, Acupuncture, Single Use	General Hospital	Class 2	880.5580	2012-12-19

Official Correspondent

Suk keun Jung

US Agent Details

Huichao Lee Email: info@smbusa.com Phone: (734) 6297552

Related Public Records

Same Entity

WOOJEON COMPANY

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 3010201636. Last updated year: 2026. Please use registration number 3010201636 when referencing this establishment in official correspondence.