Mediana Co L T D

FDA Filings

This page includes the latest FDA filings for Mediana Co L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

KOREA REP OF

KOREA EXCHANGE (KOSDAQ)

041920

DUNS 687879726

Mediana Co L T D holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

• CHARLES MACK

FDA Registration(s)

• Registration Number: 3003591740
• FEI Number: 3003591740
• Name: CHARLES MACK
• Owner & Operator: MEDIANA CO., LTD.
• Contact Address: 132, Donghwagongdan-ro, Munmak-eup ; WONJU-SI KR-42 Gangweondo 220-801 KR
• US Agent:
  • CHARLES MACK
  • IRC USA
  • 931 6254938 0
  • 541 3765063
  • ircfda@gmail.com
• Importing Logistics Registration:
  • Importer: Cardiac Science Corporation
  • Address: 3303 Monte Villa Parkway ; Bothell, WA 98021 UNITED STATES
• Importing Logistics Registration:
  • Importer: Mediana Co., Ltd.
  • Address: Wonju Medical Industry Park, 1650-1 Donghwa-ri, Munmak-eup ; Wonju-si, 220-801 KOREA, REPUBLIC OF
  • Subdivision: KR-42
• Importing Logistics Registration:
  • Importer: Schiller AG Swtizerland
  • Address: Altgasse 68, CH-6341 Baar ; Baar, 6341 SWITZERLAND
  • Subdivision: CH-NOTA
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 2950 E Lindrick Dr. ; Chandler, AZ 85249 US
• Establishment Type:
  • Manufacture Medical Device for Another Party (Contract Manufacturer)
  • Manufacture Medical Device

FDA Filings

Device Company	Device	Date
GUDID 08800003471508 Mediana.CO.LTD	Mediana Co., Ltd. Body Composition Analyzer I30	2023-08-31
GUDID 08800003468881 Mediana.CO.LTD	Mediana Co., Ltd. Body Composition Analyzer I25	2023-08-31
GUDID 08800003467235 Mediana.CO.LTD	Mediana Co., Ltd. Body Composition Analyzer I55	2023-08-31
GUDID 08800003467228 Mediana.CO.LTD	Mediana Co., Ltd. Body Composition Analyzer I50	2023-08-31
GUDID 08800003466412 Mediana.CO.LTD	Mediana Co., Ltd. Body Composition Analyzer I55	2023-08-31
GUDID 08800003466405 Mediana.CO.LTD	Mediana Co., Ltd. Body Composition Analyzer I50	2023-08-31
GUDID 08800003466115 Mediana.CO.LTD	Mediana Co., Ltd. Body Composition Analyzer I35	2023-08-31
GUDID 08800003458349 Mediana.CO.LTD	Mediana Co., Ltd. Body Composition Analyzer I35	2023-08-31
GUDID 08800003458301 Mediana.CO.LTD	Mediana Co., Ltd. Body Composition Analyzer I25	2023-08-31
GUDID 08800003455928 Mediana.CO.LTD	Mediana Co., Ltd. Body Composition Analyzer I20 I20M-XBXUS	2023-08-31
GUDID 08800003455805 Mediana.CO.LTD	Mediana Co., Ltd. Body Composition Analyzer I30	2023-08-31
GUDID 18800003465535 Mediana.CO.LTD	Direct Supply AVSM3SNF-3XBNDU	2021-07-01
GUDID 18800003465528 Mediana.CO.LTD	Direct Supply AVSM3SNF-3XBNEU	2021-06-28
GUDID 18800003460066 Mediana.CO.LTD	Direct Supply AVSM3SNF-3XBNTU	2020-12-25
PMN K200434 Mediana Co., Ltd.	V20, V20a, AVSM3 SNF	2020-10-09
GUDID 18800003456847 Mediana.CO.LTD	Direct Supply V10D-3XBNFU	2020-07-02
GUDID 18800003456809 Mediana.CO.LTD	Direct Supply V10D-3XBCFU	2020-03-16
GUDID 18800003447494 Mediana.CO.LTD	Direct Supply V10D-3XBNZU	2020-02-06
GUDID 18800003447487 Mediana.CO.LTD	Direct Supply V10D-3PBNRU	2020-02-06
GUDID 18800003447470 Mediana.CO.LTD	Direct Supply V10D-3XBNRU	2020-02-06
GUDID 18800003439444 Mediana.CO.LTD	Direct Supply V10D-3XBCRU	2020-02-06
GUDID 18800003439437 Mediana.CO.LTD	Direct Supply V10D-3XBCZU	2020-02-06
GUDID 18800003439420 Mediana.CO.LTD	Direct Supply V10D-3PBCRU	2020-02-06
GUDID 18800003428929 Mediana.CO.LTD	Patient Monitor M30 M30M-5PNXAH	2020-02-06
GUDID 18800003427847 Mediana.CO.LTD	Patient Monitor M30 M30M-3PXAH	2020-02-06
GUDID 18800003427205 Mediana.CO.LTD	Patient Monitor M30 M30M-1PXAH	2020-02-06
GUDID 18800003424990 Mediana.CO.LTD	Direct Supply V10D-3PXCRU	2020-02-06
GUDID 18800003424952 Mediana.CO.LTD	Direct Supply V10D-3PXNRU	2020-02-06
GUDID 18800003424808 Mediana.CO.LTD	Direct Supply V10D-3XXCZU	2020-02-06
GUDID 18800003424792 Mediana.CO.LTD	Direct Supply V10D-3XXCRU	2020-02-06
GUDID 18800003424761 Mediana.CO.LTD	Direct Supply V10D-3XXNZU	2020-02-06
GUDID 18800003424754 Mediana.CO.LTD	Direct Supply V10D-3XXNRU	2020-02-06
GUDID 18800003408891 Mediana.CO.LTD	Patient Monitor V10 V10M-3PLNZU	2020-02-06
GUDID 18800003408884 Mediana.CO.LTD	Patient Monitor V10 V10M-3PLNRU	2020-02-06
GUDID 18800003408693 Mediana.CO.LTD	Patient Monitor V10 V10M-3PXCZU	2020-02-06
GUDID 18800003408686 Mediana.CO.LTD	Patient Monitor V10 V10M-3PXCRU	2020-02-06
GUDID 18800003408495 Mediana.CO.LTD	Patient Monitor V10 V10M-3XXCZU	2020-02-06
GUDID 18800003408488 Mediana.CO.LTD	Patient Monitor V10 V10M-3XXCRU	2020-02-06
GUDID 18800003407795 Mediana.CO.LTD	Patient Monitor V10 V10M-2PXCZU	2020-02-06
GUDID 18800003407788 Mediana.CO.LTD	Patient Monitor V10 V10M-2PXCRU	2020-02-06
GUDID 18800003407757 Mediana.CO.LTD	Patient Monitor V10 V10M-2PXNZU	2020-02-06
GUDID 18800003407740 Mediana.CO.LTD	Patient Monitor V10 V10M-2PXNRU	2020-02-06
GUDID 18800003400574 Mediana.CO.LTD	Direct Supply PA3DS-PB0	2020-02-06
GUDID 18800003400567 Mediana.CO.LTD	Direct Supply PA3DS-B0	2020-02-06
PUH CHARLES MACK [MEDIANA CO., LTD.]	I20,I30	2019-10-31
PUH CHARLES MACK [MEDIANA CO., LTD.]	Body Composition Analyzer	2019-10-31
GUDID 18800003445537 Mediana.CO.LTD	Non-contact Infrared Thermometer DT-100 00885	2018-08-03
PMN K160358 | FLL CHARLES MACK [MEDIANA CO., LTD.]	DT-100	2018-06-29
PMN K170497 | FLL CHARLES MACK [MEDIANA CO., LTD.]	V10	2018-01-15
PMN K170497 | FLL CHARLES MACK [MEDIANA CO., LTD.]	AVSM2	2018-01-15
PMN K170497 | DXN CHARLES MACK [MEDIANA CO., LTD.]	V10	2018-01-15
PMN K170497 | DXN CHARLES MACK [MEDIANA CO., LTD.]	AVSM2	2018-01-15
PMN K170497 | DQA CHARLES MACK [MEDIANA CO., LTD.]	V10	2018-01-15
PMN K170497 | DQA CHARLES MACK [MEDIANA CO., LTD.]	AVSM2	2018-01-15
PMN K170497 Mediana Co., Ltd.	V10	2017-12-15
PMN K160358 Mediana Co., Ltd.	DT-100	2017-02-24
FWF CHARLES MACK [MEDIANA CO., LTD.]	Insight-One	2016-10-13
FWF CHARLES MACK [MEDIANA CO., LTD.]	Insight-I	2016-10-13
FSO CHARLES MACK [MEDIANA CO., LTD.]	Insight-micro+	2016-10-13
PMN K152659 MEDIANA CO., LTD	V10	2016-08-25
PMN K152369 | IYN CHARLES MACK [MEDIANA CO., LTD.]	Diagnostic Ultrasuond System	2016-06-29
PMN K142865 | DQA CHARLES MACK [MEDIANA CO., LTD.]	Nellcor Bedside SpO2 Patient Monitoring System (PM100N)	2015-03-27
PMN K141542 | DQA CHARLES MACK [MEDIANA CO., LTD.]	Nellcor Potable SpO2 Patient Monitoring System	2014-10-27
PMN K120773 | DQA CHARLES MACK [MEDIANA CO., LTD.]	Nellcor Bedside SpO2 Patient Monitoring System	2012-07-17
PMN K120773 | DQA CHARLES MACK [MEDIANA CO., LTD.]	NBSPMS	2012-07-17
PMN K112190 | MHX CHARLES MACK [MEDIANA CO., LTD.]	PATIENT MONITOR,YM6000	2012-01-13
PMN K112190 MEDIANA CO., LTD.	PATIENT MONITOR	2011-11-09
PMN K110612 MEDIANA CO., LTD.	FM20	2011-11-08
PMN K071645 | MWI CHARLES MACK [MEDIANA CO., LTD.]	HBP-T105	2011-10-26
PMN K110630 MEDIANA CO., LTD.	F10	2011-06-24
PMN K100225 MEDIANA CO., LTD.	PULSE OXIMETER MODEL P10	2011-02-09
PMN K082045 | MHX CHARLES MACK [MEDIANA CO., LTD.]	Model 91220	2010-11-30
PMN K062095 | MHX CHARLES MACK [MEDIANA CO., LTD.]	Model 91220	2010-11-30
PMN K082812 | MWI CHARLES MACK [MEDIANA CO., LTD.]	VITAL SIGNS MONITOR	2010-08-16
PMN K082812 | MWI CHARLES MACK [MEDIANA CO., LTD.]	S207	2010-08-16
PMN K082812 | MWI CHARLES MACK [MEDIANA CO., LTD.]	MODEL HBP-2070	2010-08-16
PMN K082812 | FLL CHARLES MACK [MEDIANA CO., LTD.]	VITAL SIGNS MONITOR	2010-08-16
PMN K082812 | FLL CHARLES MACK [MEDIANA CO., LTD.]	S207	2010-08-16
PMN K082812 | FLL CHARLES MACK [MEDIANA CO., LTD.]	MODEL HBP-2070	2010-08-16
PMN K082812 | DXN CHARLES MACK [MEDIANA CO., LTD.]	VITAL SIGNS MONITOR	2010-08-16
PMN K082812 | DXN CHARLES MACK [MEDIANA CO., LTD.]	S207	2010-08-16
PMN K082812 | DXN CHARLES MACK [MEDIANA CO., LTD.]	MODEL HBP-2070	2010-08-16
PMN K082812 | DQA CHARLES MACK [MEDIANA CO., LTD.]	VITAL SIGNS MONITOR	2010-08-16
PMN K082812 | DQA CHARLES MACK [MEDIANA CO., LTD.]	S207	2010-08-16
PMN K082812 | DQA CHARLES MACK [MEDIANA CO., LTD.]	MODEL HBP-2070	2010-08-16
PMN K100217 | MHX CHARLES MACK [MEDIANA CO., LTD.]	Patient Monitor	2010-07-01
PMN K100217 | MHX CHARLES MACK [MEDIANA CO., LTD.]	Lucon M-series (M20, M30)	2010-07-01
PMN K100217 MEDIANA CO., LTD.	LUCON M-SERIES PATIENT MONITOR, MODELS M20 AND M30	2010-06-08
PMN K063690 | MHX CHARLES MACK [MEDIANA CO., LTD.]	BP S510 Colin Press Mate	2009-03-28
PMN K063690 | DXN CHARLES MACK [MEDIANA CO., LTD.]	BP S510 Colin Press Mate	2009-03-28
PMN K063690 | DSK CHARLES MACK [MEDIANA CO., LTD.]	BP S510 Colin Press Mate	2009-03-28
PMN K063690 | DQA CHARLES MACK [MEDIANA CO., LTD.]	BP S510 Colin Press Mate	2009-03-28
PMN K063690 | DPS CHARLES MACK [MEDIANA CO., LTD.]	BP S510 Colin Press Mate	2009-03-28
PMN K063690 | CCK CHARLES MACK [MEDIANA CO., LTD.]	BP S510 Colin Press Mate	2009-03-28
PMN K051375 | DXN CHARLES MACK [MEDIANA CO., LTD.]	YM1000	2005-08-15
PMN K051375 | DXN CHARLES MACK [MEDIANA CO., LTD.]	VITAL SIGNS MONITOR	2005-08-15
PMN K051375 | DXN CHARLES MACK [MEDIANA CO., LTD.]	AVM-1	2005-08-15
PMN K051375 | DXN CHARLES MACK [MEDIANA CO., LTD.]	ARGUS VCM SERIES	2005-08-15
PMN K021090 | DQA CHARLES MACK [MEDIANA CO., LTD.]	N-560	2005-08-15
PMN K021090 | DQA CHARLES MACK [MEDIANA CO., LTD.]	MULTIPLE NAMES USED	2005-08-15
PMN K051375 MEDIANA CO., LTD.	VITAL SIGNS MONITOR	2005-07-28

Related Finance Registrations

NCAGE Code	1G61F	MEDIANA.CO.LTD
CAGE Code	1G61F	MEDIANA.CO.LTD

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
20200811115945	Pusan,South Korea -> Seattle, Washington	PARTS FOR PATIENT MONITOR 9018.19-9000	1 PKG
2020060853535	Pusan,South Korea -> Seattle, Washington	PARTS FOR PATIENT MONITOR 9018.19-9000	5 PKG
2020050519122	Pusan,South Korea -> New York/Newark Area, Newark, New Jersey	PULSE OXIMETER INV NO MA020-0032 5 PLT (432 BOXES) HS-CODE 9018190000	432 CTN
2020050457247	Pusan,South Korea -> Seattle, Washington	PARTS FOR PATIENT MONITOR 9018.19-9000	1 PKG
2020030317838	Pusan,South Korea -> New York/Newark Area, Newark, New Jersey	PULSE OXIMETER INV NO MA020-0006 5 PLT (432 BOXES) HS-CODE 9018190000	432 CTN
2020011715562	Pusan,South Korea -> New York/Newark Area, Newark, New Jersey	PULSE OXIMETER INV NO MA019-0103104 7 PLT (648 BOXES) HS-CODE 9018190000	648 CTN
2020011023753	Pusan,South Korea -> New York/Newark Area, Newark, New Jersey	PULSE OXIMETER INV NO MA019-0099 3 PLTS(216BOXES) HS-CODE 9018190000	216 CTN
2019111113221	Pusan,South Korea -> New York/Newark Area, Newark, New Jersey	PULSE OXIMETER INV NO MA019-0074 MA019-0075 5 PLTS(432BOXES) HS-CODE 9018190000	432 CTN