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 OFKOREA EXCHANGE (KOSDAQ)041920DUNS 687879726

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

FDA Registration(s)
Registration Number3003591740
FEI Number3003591740
NameCHARLES MACK
Owner & OperatorMEDIANA CO., LTD.
Contact Address132, Donghwagongdan-ro, Munmak-eup
WONJU-SI KR-42 Gangweondo 220-801 KR
US Agent
Importing Logistics Registration
ImporterCardiac Science Corporation
Address3303 Monte Villa Parkway
Bothell, WA 98021 UNITED STATES
Importing Logistics Registration
ImporterMediana Co., Ltd.
AddressWonju Medical Industry Park, 1650-1 Donghwa-ri, Munmak-eup
Wonju-si, 220-801 KOREA, REPUBLIC OF
SubdivisionKR-42
Importing Logistics Registration
ImporterSchiller AG Swtizerland
AddressAltgasse 68, CH-6341 Baar
Baar, 6341 SWITZERLAND
SubdivisionCH-NOTA
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address2950 E Lindrick Dr.
Chandler, AZ 85249 US
Establishment Type
  • Manufacture Medical Device for Another Party (Contract Manufacturer)
  • Manufacture Medical Device



FDA Filings

Device
Company
DeviceDate
Mediana Co., Ltd.
V20, V20a, AVSM3 SNF2020-10-09
Mediana.CO.LTD
Direct Supply V10D-3XBNFU2020-07-02
Mediana.CO.LTD
Direct Supply V10D-3XBCFU2020-03-16
Mediana.CO.LTD
Direct Supply V10D-3XBNZU2020-02-06
Mediana.CO.LTD
Direct Supply V10D-3PBNRU2020-02-06
Mediana.CO.LTD
Direct Supply V10D-3XBNRU2020-02-06
Mediana.CO.LTD
Direct Supply V10D-3XBCRU2020-02-06
Mediana.CO.LTD
Direct Supply V10D-3XBCZU2020-02-06
Mediana.CO.LTD
Direct Supply V10D-3PBCRU2020-02-06
Mediana.CO.LTD
Patient Monitor M30 M30M-5PNXAH2020-02-06
Mediana.CO.LTD
Patient Monitor M30 M30M-3PXAH2020-02-06
Mediana.CO.LTD
Patient Monitor M30 M30M-1PXAH2020-02-06
Mediana.CO.LTD
Direct Supply V10D-3PXCRU2020-02-06
Mediana.CO.LTD
Direct Supply V10D-3PXNRU2020-02-06
Mediana.CO.LTD
Direct Supply V10D-3XXCZU2020-02-06
Mediana.CO.LTD
Direct Supply V10D-3XXCRU2020-02-06
Mediana.CO.LTD
Direct Supply V10D-3XXNZU2020-02-06
Mediana.CO.LTD
Direct Supply V10D-3XXNRU2020-02-06
Mediana.CO.LTD
Patient Monitor V10 V10M-3PLNZU2020-02-06
Mediana.CO.LTD
Patient Monitor V10 V10M-3PLNRU2020-02-06
Mediana.CO.LTD
Patient Monitor V10 V10M-3PXCZU2020-02-06
Mediana.CO.LTD
Patient Monitor V10 V10M-3PXCRU2020-02-06
Mediana.CO.LTD
Patient Monitor V10 V10M-3XXCZU2020-02-06
Mediana.CO.LTD
Patient Monitor V10 V10M-3XXCRU2020-02-06
Mediana.CO.LTD
Patient Monitor V10 V10M-2PXCZU2020-02-06
Mediana.CO.LTD
Patient Monitor V10 V10M-2PXCRU2020-02-06
Mediana.CO.LTD
Patient Monitor V10 V10M-2PXNZU2020-02-06
Mediana.CO.LTD
Patient Monitor V10 V10M-2PXNRU2020-02-06
Mediana.CO.LTD
Direct Supply PA3DS-PB02020-02-06
Mediana.CO.LTD
Direct Supply PA3DS-B02020-02-06
CHARLES MACK [MEDIANA CO., LTD.]
I20,I302019-10-31
CHARLES MACK [MEDIANA CO., LTD.]
Body Composition Analyzer2019-10-31
Mediana.CO.LTD
Non-contact Infrared Thermometer DT-100 008852018-08-03
CHARLES MACK [MEDIANA CO., LTD.]
DT-1002018-06-29
CHARLES MACK [MEDIANA CO., LTD.]
V102018-01-15
CHARLES MACK [MEDIANA CO., LTD.]
AVSM22018-01-15
CHARLES MACK [MEDIANA CO., LTD.]
V102018-01-15
CHARLES MACK [MEDIANA CO., LTD.]
AVSM22018-01-15
CHARLES MACK [MEDIANA CO., LTD.]
V102018-01-15
CHARLES MACK [MEDIANA CO., LTD.]
AVSM22018-01-15
Mediana Co., Ltd.
V102017-12-15
Mediana Co., Ltd.
DT-1002017-02-24
CHARLES MACK [MEDIANA CO., LTD.]
Insight-One2016-10-13
CHARLES MACK [MEDIANA CO., LTD.]
Insight-I2016-10-13
CHARLES MACK [MEDIANA CO., LTD.]
Insight-micro+2016-10-13
MEDIANA CO., LTD
V102016-08-25
CHARLES MACK [MEDIANA CO., LTD.]
Diagnostic Ultrasuond System2016-06-29
CHARLES MACK [MEDIANA CO., LTD.]
Nellcor Bedside SpO2 Patient Monitoring System (PM100N)2015-03-27
CHARLES MACK [MEDIANA CO., LTD.]
Nellcor Potable SpO2 Patient Monitoring System2014-10-27
CHARLES MACK [MEDIANA CO., LTD.]
Nellcor Bedside SpO2 Patient Monitoring System2012-07-17
CHARLES MACK [MEDIANA CO., LTD.]
NBSPMS2012-07-17
CHARLES MACK [MEDIANA CO., LTD.]
PATIENT MONITOR,YM60002012-01-13
MEDIANA CO., LTD.
PATIENT MONITOR2011-11-09
MEDIANA CO., LTD.
FM202011-11-08
CHARLES MACK [MEDIANA CO., LTD.]
HBP-T1052011-10-26
MEDIANA CO., LTD.
F102011-06-24
MEDIANA CO., LTD.
PULSE OXIMETER MODEL P102011-02-09
CHARLES MACK [MEDIANA CO., LTD.]
Model 912202010-11-30
CHARLES MACK [MEDIANA CO., LTD.]
Model 912202010-11-30
CHARLES MACK [MEDIANA CO., LTD.]
VITAL SIGNS MONITOR2010-08-16
CHARLES MACK [MEDIANA CO., LTD.]
S2072010-08-16
CHARLES MACK [MEDIANA CO., LTD.]
MODEL HBP-20702010-08-16
CHARLES MACK [MEDIANA CO., LTD.]
VITAL SIGNS MONITOR2010-08-16
CHARLES MACK [MEDIANA CO., LTD.]
S2072010-08-16
CHARLES MACK [MEDIANA CO., LTD.]
MODEL HBP-20702010-08-16
CHARLES MACK [MEDIANA CO., LTD.]
VITAL SIGNS MONITOR2010-08-16
CHARLES MACK [MEDIANA CO., LTD.]
S2072010-08-16
CHARLES MACK [MEDIANA CO., LTD.]
MODEL HBP-20702010-08-16
CHARLES MACK [MEDIANA CO., LTD.]
VITAL SIGNS MONITOR2010-08-16
CHARLES MACK [MEDIANA CO., LTD.]
S2072010-08-16
CHARLES MACK [MEDIANA CO., LTD.]
MODEL HBP-20702010-08-16
CHARLES MACK [MEDIANA CO., LTD.]
Patient Monitor2010-07-01
CHARLES MACK [MEDIANA CO., LTD.]
Lucon M-series (M20, M30)2010-07-01
MEDIANA CO., LTD.
LUCON M-SERIES PATIENT MONITOR, MODELS M20 AND M302010-06-08
CHARLES MACK [MEDIANA CO., LTD.]
BP S510 Colin Press Mate2009-03-28
CHARLES MACK [MEDIANA CO., LTD.]
BP S510 Colin Press Mate2009-03-28
CHARLES MACK [MEDIANA CO., LTD.]
BP S510 Colin Press Mate2009-03-28
CHARLES MACK [MEDIANA CO., LTD.]
BP S510 Colin Press Mate2009-03-28
CHARLES MACK [MEDIANA CO., LTD.]
BP S510 Colin Press Mate2009-03-28
CHARLES MACK [MEDIANA CO., LTD.]
BP S510 Colin Press Mate2009-03-28
CHARLES MACK [MEDIANA CO., LTD.]
YM10002005-08-15
CHARLES MACK [MEDIANA CO., LTD.]
VITAL SIGNS MONITOR2005-08-15
CHARLES MACK [MEDIANA CO., LTD.]
AVM-12005-08-15
CHARLES MACK [MEDIANA CO., LTD.]
ARGUS VCM SERIES2005-08-15
CHARLES MACK [MEDIANA CO., LTD.]
N-5602005-08-15
CHARLES MACK [MEDIANA CO., LTD.]
MULTIPLE NAMES USED2005-08-15
MEDIANA CO., LTD.
VITAL SIGNS MONITOR2005-07-28

Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
20200811115945Pusan,South Korea -> Seattle, WashingtonPARTS FOR PATIENT MONITOR 9018.19-90001 PKG
2020060853535Pusan,South Korea -> Seattle, WashingtonPARTS FOR PATIENT MONITOR 9018.19-90005 PKG
2020050519122Pusan,South Korea -> New York/Newark Area, Newark, New JerseyPULSE OXIMETER INV NO MA020-0032 5 PLT (432 BOXES) HS-CODE 9018190000432 CTN
2020050457247Pusan,South Korea -> Seattle, WashingtonPARTS FOR PATIENT MONITOR 9018.19-90001 PKG
2020030317838Pusan,South Korea -> New York/Newark Area, Newark, New JerseyPULSE OXIMETER INV NO MA020-0006 5 PLT (432 BOXES) HS-CODE 9018190000432 CTN
2020011715562Pusan,South Korea -> New York/Newark Area, Newark, New JerseyPULSE OXIMETER INV NO MA019-0103104 7 PLT (648 BOXES) HS-CODE 9018190000648 CTN
2020011023753Pusan,South Korea -> New York/Newark Area, Newark, New JerseyPULSE OXIMETER INV NO MA019-0099 3 PLTS(216BOXES) HS-CODE 9018190000216 CTN
2019111113221Pusan,South Korea -> New York/Newark Area, Newark, New JerseyPULSE OXIMETER INV NO MA019-0074 MA019-0075 5 PLTS(432BOXES) HS-CODE 9018190000432 CTN

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