Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010126182

FEI Number

3010126182

Entity Name

WOORHI MECHATRONICS

City/State/Country

Gunpo-si Gyeonggi, KR

Establishment Address

5th Floor Woorhi Mecha Building, 58 San bon-ro 48 beon-gil, Gunpo-si Gyeonggi 15846, KR

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Woorhi Mechatronics (Owner Number: 10093681)

Owner / Operator Contact Address

5th Floor Woorhi Mecha Building, 58 San bon-ro 48 beon-gil, Gunpo-si, KR-41 15846, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

DP 4 DP 4 Needle Cartridge Dermapen 4

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QAI	Powered Microneedle Device	General, Plastic Surgery	Class 2	878.4430	2025-06-23

Official Correspondent

Yong Woon Woo

US Agent Details

Shaun Kerrigan Business: Equipmed USA LLC Email: shaun.kerrigan@fecclaw.com Phone: (949) 7985500

Related Public Records

Same Entity

Woorhi Mechatronics

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 3010126182. Last updated year: 2026. Please use registration number 3010126182 when referencing this establishment in official correspondence.