Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008937712

FEI Number

3008937712

Entity Name

Seegene Inc.

City/State/Country

Songpa-gu Seoul, KR

Establishment Address

Taewon Building, 91, Ogeum-ro, Songpa-gu Seoul 05548, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Seegene Inc. (Owner Number: 10060570)

Owner / Operator Contact Address

Taewon Building, 91, Ogeum-Ro, Songpa-gu, KR-11 05548, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Seegene STARlet STARMag 96x4 Universal Cartridge Kit STARMag 96x4 Universal Plus Cartridge Kit STARMag 96 X 4 Viral DNA/RNA 200 C Kit Seegene NIMBUS STARMag M96 Kit STARprep EZ Buffer

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JJH	Clinical Sample Concentrator	Clinical Chemistry	Class 1	862.2310	2019-05-28

Official Correspondent

Hwalee Ryu

US Agent Details

Jun Byum Kim Business: Seegene USA, Inc. Email: jbkim@seegene.com Phone: (800) 7252167

Related Public Records

Same Entity

Seegene 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 3008937712. Last updated year: 2026. Please use registration number 3008937712 when referencing this establishment in official correspondence.