Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008624479

FEI Number

3008624479

Entity Name

MEDIKAN CO., Ltd.

City/State/Country

Gangseo-gu Seoul, KR

Establishment Address

Rm 502 Gayang Techno Town Bldg., 217 Heojun-ro, Gangseo-gu, Gangseo-gu Seoul 07531, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Medikan Co., Ltd. (Owner Number: 10089085)

Owner / Operator Contact Address

Rm 502 Gayang Techno Town Bldg., 217 Heojun-ro, Gangseo-gu, Gangseo-gu, KR-11 07531, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

X-Trap Celltibator GT TP-118 TP-113 TP-107 TP-119 TP-111 TP-117 TP-112 TP-109 TP-106 TP-118B FG-103 STEM-XE Combi 416K Lipokit STEM-X Lipomini Time Capsule TaraLock Celltibator Breathe Celltibator GTX Mystem TP-203 TP-201 TP-202 TP-204 TP-207 TP-205 Filler geller RainbowScope Celltibator GTX Inner Chamber Megakit Celltibator GT Celltibator Breathe

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KET	Filters, Cell Collection, Tissue Processing	Pathology	Class 1	864.3010	2025-02-12
KJE	Spinner System, Cell Culture	Hematology	Class 1	864.2240	2025-02-12
IQG	Adaptor, Holder, Syringe	Physical Medicine	Class 1	890.5050	2025-08-07
QBV	Centrifuge For Preparation Of Cell Concentrate And/Or Plasma Concentrate	Clinical Chemistry	Class 1	862.2050	2024-08-26
GCY	Apparatus, Suction, Single Patient Use, Portable, Nonpowered	General, Plastic Surgery	Class 1	878.4680	2025-01-21
KYW	Container, Liquid Medication, Graduated	General Hospital	Class 1	880.6430	2025-02-12
GCX	Apparatus, Suction, Operating-Room, Wall Vacuum Powered	General Hospital	Class 2	880.6740	2024-09-09
KJF	System, Suspension, Cell Culture	Hematology	Class 1	864.2240	2025-02-12
GEA	Cannula, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2025-08-07
LEC	Grinder, Tissue	Pathology	Class 1	864.3010	2025-01-23
IBJ	Light, Microscope	Pathology	Class 1	864.3600	2025-02-12
KIT	Media And Components, Synthetic Cell And Tissue Culture	Hematology	Class 1	864.2220	2025-01-22

Official Correspondent

No official correspondent registered.

US Agent Details

Christopher Peeters Business: Cell Surgical Network Corp. Email: Chris@cellsurgicalnetwork.com Phone: (760) 4240488

Related Public Records

Same Entity

Medikan Co., Ltd.

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K883982	Iberhospitex, S.A.	DRENOVAC	1989-02-23
K863293	Lifestream Int'L, Inc.	DISPOSABLE SUCTION CANNULA NO. 902008-000	1986-09-09
K832690	Sigma Chemical Co.	MINIMUM ESSENTIAL MED. EAGLE M0268	1983-09-12
K861867	Hazleton Research Products, Inc.	MEM ALPHA EAGLE MEDIUM	1986-05-29
K821916	Dutchland Laboratories, Inc.	IMPROVED MEM-RICHTER'S POWDER MODIF.	1982-07-27

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0020-04	Vital Concepts, Inc.	1	Huntington Instruments brand Irrigation Aspiration System with Single Spike Tubing and 33 cm Probe, Disposable (single use only), sterile, latex free. Catalog # 55040. Labeled as Manufactured for Huntington Instruments, Ogden Utah.
Z-0021-04	Vital Concepts, Inc.	1	Irrigation Aspiration System with Double Spike Tubing and 33 cm Probe, Disposable (single use only), sterile, latex free. Catalog # 55060. HYDRO-PRO brand labeled as sold by Vital Concepts, Inc., Grand Rapids, Michigan. Huntington Instruments brand labeled as Manufactured for Huntington Instruments, Ogden Utah. Quanta Technologies L.L.C. brand Manufactured for Quanta Technologies, L.L.C., Tucson, AZ. Catalogue # 55060-10 sold in Canada and labeled as Manufactured for Jac-Cell Medic, Dorval, Quebec.
Z-0022-04	Vital Concepts, Inc.	1	HYDRO-PRO brand Irrigation Aspiration System with double Spike Tubing, no Probe, Disposable (single use only), sterile, latex free. Catalog # 55160. Vital Concepts, Inc., Grand Rapids, Michigan.
Z-0023-04	Vital Concepts, Inc.	1	HYDRO-PRO brand Suction-Irrigation System without Probe, Disposable (single use only), sterile, latex free. R-Med Re-Order # 55170R; Distributed by R-Med, Inc., Orgeon, OH
Z-0024-04	Vital Concepts, Inc.	1	Quanta Technologies L.L.C. brand REORDER # LAPKIT 3. Contents 1 -55060 Suction/Irrigation Valve 2- 30012 Insufflation Tubing set 3- 5010 Anti Fog Solution with Sponge. Manufactured for Quanta Technologies, L.L.C., Tucson, AZ.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008624479. Last updated year: 2026. Please use registration number 3008624479 when referencing this establishment in official correspondence.