Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3038181305

FEI Number

3038181305

Entity Name

FORTUNA HELIX

City/State/Country

Seoul, KR

Establishment Address

Seoul Biohub Global Center, Suite 502, 117-3 Hoegi-ro, Dongdaemun-gu, Seoul 02455, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Fortuna Helix (Owner Number: 10093089)

Owner / Operator Contact Address

Seoul Biohub Global Center, Suite 502, 117-3 Hoegi-ro, Dongdaemun-gu, Seoul, KR-11 02455, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Fortuna Helix GenPredict: Disease

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PTA	Genetic Variant Detection And Health Risk Assessment System	Immunology	Class 2	866.5950	2025-04-03

Official Correspondent

Bermseok Oh

US Agent Details

Gonjin Choi Email: nutrichoi@gmail.com Phone: (949) 3167388

Related Public Records

Same Entity

Fortuna Helix

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Similar Registrations

Registration Number	Establishment Name	Location
3015489159	ALOM Technologies Corporation	Indianapolis, IN, US
3003436513	ASURAGEN, INC.	AUSTIN, TX, US
3004597845	ALOM TECHNOLOGIES CORPORATION	FREMONT, CA, US
3035380687	TARGETED GENOMICS, LLC	Irvine, CA, US
3018077536	SUPERA FULFILLMENT LLC	Houston, TX, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3038181305. Last updated year: 2026. Please use registration number 3038181305 when referencing this establishment in official correspondence.