Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3034246178

FEI Number

3034246178

Entity Name

CTCELLS, INC.

City/State/Country

Seoul, KR

Establishment Address

216, Gaepo-Ro, Gangnam-Gu, Seoul 06307, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

CTCELLS, Inc. (Owner Number: 10092057)

Owner / Operator Contact Address

216, Gaepo-Ro, Gangnam-Gu, Seoul, KR-11 06307, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

CTCeptor (Model: CTM-C1203) / Consumables: CTCD(Model: CTD-C103), CTR-S(Model: CTR-SP1001)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GKH	Apparatus, Automated Blood Cell Diluting	Hematology	Class 1	864.5240	2024-11-28

Official Correspondent

Minsuk Kim

US Agent Details

Eugene Sa Business: CTCELLS USA, Inc. Email: eugenesa@ctcells.com Phone: (323) 8998737

Related Public Records

Same Entity

CTCELLS, 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 3034246178. Last updated year: 2026. Please use registration number 3034246178 when referencing this establishment in official correspondence.