Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3042204925

FEI Number

3042204925

Entity Name

Mand.ro Co., Ltd.

City/State/Country

Bucheon-si Gyeonggi, KR

Establishment Address

202-802, Chun-Ui Technopark 2, 18, Bucheon-ro 198beon-gil, Wonmi-gu,, Bucheon-si Gyeonggi 14557, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Mand.ro Co., Ltd. (Owner Number: 10094346)

Owner / Operator Contact Address

202-802, Chun-Ui Technopark 2, 18, Bucheon-ro 198beon-gil, Wonmi-gu,, Bucheon-si, KR-41 14557, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Cosmetic Passive Hand Mand.ro Mark 7X Mand.ro Mark 7 Mand.ro Mark 7A Mand.ro Mark 7D Mand.ro Mark 5 Mand.ro Mark 7B

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IRA	Hand, External Limb Component, Mechanical	Physical Medicine	Class 1	890.3420	2025-12-18
IQZ	Hand, External Limb Component, Powered	Physical Medicine	Class 1	890.3420	2025-11-24

Official Correspondent

Sangho Yi

US Agent Details

GLENN CHOI Business: ST&G USA Corporation Email: glenn@stngco.com Phone: (714) 3963739

Related Public Records

Same Entity

Mand.ro 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 3042204925. Last updated year: 2026. Please use registration number 3042204925 when referencing this establishment in official correspondence.