Molnlycke Health Care Sdn Bhd

FDA Filings

This page includes the latest FDA filings for Molnlycke Health Care Sdn Bhd. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number9610054
FEI Number1000207790
NameMolnlycke Health Care SDN BHD
Owner & OperatorMOLNLYCKE HEALTH CARE US LLC
Contact Address5550 Peachtree Parkway, Suite 500
Norcross GA 30092 US
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressLOT 9, LORONG PERUSAHAAN, KULIM IND. ESTATE
KULIM, KEDAH DARULAMAN Kedah, 09000 MY
Establishment TypeManufacture Medical Device



Registration Number3010309112
FEI Number3010309112
NameMolnlycke Health Care Sdn. Bhd.
Owner & OperatorMOLNLYCKE HEALTH CARE US LLC
Contact Address5550 Peachtree Parkway, Suite 500
Norcross GA 30092 US
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressPlot 204, Kawasan Perindustrian Kuala Ketil
Kuala Ketil Kedah, 09300 MY
Establishment TypeManufacture Medical Device



FDA Filings

Device
Company
DeviceDate
Molnlycke Health Care Sdn. Bhd. [MOLNLYCKE HEALTH CARE US LLC]
Biogel PI UltraTouch S Surgical Glove2019-09-25
Molnlycke Health Care Sdn. Bhd. [MOLNLYCKE HEALTH CARE US LLC]
Biogel PI UltraTouch S Indicator Underglove2019-09-25
Molnlycke Health Care SDN BHD [MOLNLYCKE HEALTH CARE US LLC]
Biogel PI UltraTouch S Surgical Glove2019-09-25
Molnlycke Health Care SDN BHD [MOLNLYCKE HEALTH CARE US LLC]
Biogel PI UltraTouch S Indicator Underglove2019-09-25
Molnlycke Health Care Sdn. Bhd. [MOLNLYCKE HEALTH CARE US LLC]
Biogel PI Micro Indicator Underglove2015-12-21
Molnlycke Health Care SDN BHD [MOLNLYCKE HEALTH CARE US LLC]
Biogel PI Micro Indicator Underglove2015-12-21
Molnlycke Health Care Sdn. Bhd. [MOLNLYCKE HEALTH CARE US LLC]
Biogel PI Micro surgical glove2015-05-12
Molnlycke Health Care SDN BHD [MOLNLYCKE HEALTH CARE US LLC]
Biogel PI Micro surgical glove2015-05-12
Molnlycke Health Care Sdn. Bhd. [MOLNLYCKE HEALTH CARE US LLC]
Biogel PI OrthoPro2012-02-06
Molnlycke Health Care SDN BHD [MOLNLYCKE HEALTH CARE US LLC]
Biogel PI OrthoPro2012-02-06
Molnlycke Health Care Sdn. Bhd. [MOLNLYCKE HEALTH CARE US LLC]
Biogel PI Indicator2009-01-13
Molnlycke Health Care SDN BHD [MOLNLYCKE HEALTH CARE US LLC]
Biogel PI Indicator2009-01-13
Molnlycke Health Care Sdn. Bhd. [MOLNLYCKE HEALTH CARE US LLC]
Biogel Diagnostic2008-05-07
Molnlycke Health Care SDN BHD [MOLNLYCKE HEALTH CARE US LLC]
Biogel Diagnostic2008-05-07
Molnlycke Health Care Sdn. Bhd. [MOLNLYCKE HEALTH CARE US LLC]
Biogel Super-Sensitive surgical glove2008-05-07
Molnlycke Health Care Sdn. Bhd. [MOLNLYCKE HEALTH CARE US LLC]
Biogel Sensor Glove2008-05-07
Molnlycke Health Care SDN BHD [MOLNLYCKE HEALTH CARE US LLC]
Biogel Super-Sensitive surgical glove2008-05-07
Molnlycke Health Care SDN BHD [MOLNLYCKE HEALTH CARE US LLC]
Biogel Sensor Glove2008-05-07
Molnlycke Health Care Sdn. Bhd. [MOLNLYCKE HEALTH CARE US LLC]
Biogel Indicator Underglove2008-05-07
Molnlycke Health Care SDN BHD [MOLNLYCKE HEALTH CARE US LLC]
Biogel Indicator Underglove2008-05-07
Molnlycke Health Care Sdn. Bhd. [MOLNLYCKE HEALTH CARE US LLC]
Biogel Opti-Fit Ortho surgical gloves2008-05-07
Molnlycke Health Care SDN BHD [MOLNLYCKE HEALTH CARE US LLC]
Biogel Opti-Fit Ortho surgical gloves2008-05-07
Molnlycke Health Care Sdn. Bhd. [MOLNLYCKE HEALTH CARE US LLC]
Biogel Eclipse2008-05-07
Molnlycke Health Care SDN BHD [MOLNLYCKE HEALTH CARE US LLC]
Biogel Eclipse2008-05-07
Molnlycke Health Care Sdn. Bhd. [MOLNLYCKE HEALTH CARE US LLC]
Biogel PI surgical glove2008-05-07
Molnlycke Health Care SDN BHD [MOLNLYCKE HEALTH CARE US LLC]
Biogel PI surgical glove2008-05-07
Molnlycke Health Care Sdn. Bhd. [MOLNLYCKE HEALTH CARE US LLC]
Biogel Surgeons Glove2008-05-07
Molnlycke Health Care SDN BHD [MOLNLYCKE HEALTH CARE US LLC]
Biogel Surgeons Glove2008-05-07
Molnlycke Health Care Sdn. Bhd. [MOLNLYCKE HEALTH CARE US LLC]
Biogel Skinsense2008-05-07
Molnlycke Health Care SDN BHD [MOLNLYCKE HEALTH CARE US LLC]
Biogel Skinsense2008-05-07
Molnlycke Health Care Sdn. Bhd. [MOLNLYCKE HEALTH CARE US LLC]
Biogel PI Ultratouch G surgical glove2008-05-07
Molnlycke Health Care Sdn. Bhd. [MOLNLYCKE HEALTH CARE US LLC]
Biogel PI UltraTouch surgical glove2008-05-07
Molnlycke Health Care Sdn. Bhd. [MOLNLYCKE HEALTH CARE US LLC]
Biogel PI UltraTouch M surgical glove2008-05-07
Molnlycke Health Care Sdn. Bhd. [MOLNLYCKE HEALTH CARE US LLC]
Biogel PI Pro-Fit surgical glove2008-05-07
Molnlycke Health Care SDN BHD [MOLNLYCKE HEALTH CARE US LLC]
Biogel PI Ultratouch G surgical glove2008-05-07
Molnlycke Health Care SDN BHD [MOLNLYCKE HEALTH CARE US LLC]
Biogel PI UltraTouch surgical glove2008-05-07
Molnlycke Health Care SDN BHD [MOLNLYCKE HEALTH CARE US LLC]
Biogel PI UltraTouch M surgical glove2008-05-07
Molnlycke Health Care SDN BHD [MOLNLYCKE HEALTH CARE US LLC]
Biogel PI Pro-Fit surgical glove2008-05-07
Molnlycke Health Care Sdn. Bhd. [MOLNLYCKE HEALTH CARE US LLC]
Biogel Skinsense N2008-05-07
Molnlycke Health Care Sdn. Bhd. [MOLNLYCKE HEALTH CARE US LLC]
Biogel NeoDerm2008-05-07
Molnlycke Health Care SDN BHD [MOLNLYCKE HEALTH CARE US LLC]
Biogel Skinsense N2008-05-07
Molnlycke Health Care SDN BHD [MOLNLYCKE HEALTH CARE US LLC]
Biogel NeoDerm2008-05-07
Molnlycke Health Care Sdn. Bhd. [MOLNLYCKE HEALTH CARE US LLC]
Biogel M2008-04-02
Molnlycke Health Care SDN BHD [MOLNLYCKE HEALTH CARE US LLC]
Biogel M2008-04-02

Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020092224220Taipei,China (Taiwan) -> Oakland, CaliforniaBIOGEL SURGEON GLOVES1140 CTN
2020092224223Kaohsiung,China (Taiwan) -> Oakland, CaliforniaBIOGEL SURGEON GLOVES1140 CTN
2020092224230Kaohsiung,China (Taiwan) -> Oakland, CaliforniaBIOGEL SURGEON GLOVES1140 CTN
2020092121365Singapore,Singapore -> Charleston, South CarolinaBIOGEL SURGEON GLOVES1140 CTN
2020092119326Singapore,Singapore -> Charleston, South CarolinaBIOGEL SURGEON GLOVES1140 CTN
2020092119309Singapore,Singapore -> Charleston, South CarolinaBIOGEL SURGEON GLOVES1140 CTN
2020092119308Singapore,Singapore -> Charleston, South CarolinaBIOGEL SURGEON GLOVES1140 CTN
2020092119319Singapore,Singapore -> Charleston, South CarolinaBIOGEL SURGEON GLOVES1140 CTN

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