Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015912984

FEI Number

3015912984

Entity Name

ROKIT HEALTHCARE INC.

City/State/Country

Geumcheon-gu Seoul, KR

Establishment Address

B-1101, B-1106, 32, Digital-ro 9-gil,, Geumcheon-gu Seoul 08512, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

ROKIT HEALTHCARE Inc. (Owner Number: 10076012)

Owner / Operator Contact Address

12F, Gasan High-hill Bldg., 9, Digital-ro 10-gil, Geumcheon-gu, Seoul, KR-11 08514, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

AiD Regen APLICOR 3D Dr. INVIVO 4D2D Dr. INVIVO Scaffold Kit APLICOR 3D KIT

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OUG	Medical Device Data System	General Hospital	Class 1	880.6310	2021-04-19
KYX	Dispenser, Liquid Medication	General Hospital	Class 1	880.6430	2020-07-30

Official Correspondent

Seok-Hwan You

US Agent Details

Takahiro Haruyama Business: GLOBIZZ CORPORATION Email: register@globizz.net Phone: (310) 5383860

Related Public Records

Same Entity

ROKIT HEALTHCARE 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 3015912984. Last updated year: 2026. Please use registration number 3015912984 when referencing this establishment in official correspondence.