Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3023346439

FEI Number

3023346439

Entity Name

Miracell Co.,Ltd.

City/State/Country

Seongnam-si Gyeonggi, KR

Establishment Address

B-601~608, 215, Galmachi-ro, Jungwon-gu,, Seongnam-si Gyeonggi 06222, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Miracell Co.,Ltd. (Owner Number: 10085629)

Owner / Operator Contact Address

3F Taehyun Bldg 413 Eonju-ro, Gangnam-gu, Seoul, KR-11 06222, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K250516

PMA Number

N/A

All Registered Proprietary Names

Smart M-Cell 2 Smart M-Cell 4 SMART M-CELL PRP Concentration System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KSO	Centrifuge, Blood-Bank For In Vitro Diagnostic Use	Hematology	Class 1	864.9275	2022-07-12
QBV	Centrifuge For Preparation Of Cell Concentrate And/Or Plasma Concentrate	Clinical Chemistry	Class 1	862.2050	2026-04-17

Official Correspondent

Hyun Shin

US Agent Details

Dave Kim Business: Mtech Group LLC Email: davekim@mtechgroupllc.com Phone: (713) 4672607

Related Public Records

Same Entity

Miracell 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 3023346439. Last updated year: 2026. Please use registration number 3023346439 when referencing this establishment in official correspondence.