FDA.reportPublic FDA data

MOLNLYCKE HEALTH CARE

Matched from indexed company URL: Molnlycke Health Care

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
80206732819MOLNLYCKE HEALTH CARE1N2026-01-01TUBITON HOUSE Medlock Street OLDHAM GB OL1 3HS
96100541000207790Molnlycke Health Care SDN BHD1N2026-01-01LOT 9, LORONG PERUSAHAAN 4 KULIM INDUSTRIAL ESTATE KULIM Kedah MY 09000
30048249043004824904MOLNLYCKE HEALTH CARE, US LLC1Y2026-01-01100 Schmid Plaza Road Anderson SC US 29624
30070480573007048057Molnlycke Health Care AB1N2026-01-01Entreprenorsstraket 21 Molndal Vastra Gotaland SE SE-431 53
30103091123010309112Molnlycke Health Care Sdn. Bhd.1N2026-01-01Plot 204, Kawasan Perindustrian Kuala Ketil Kuala Ketil Kedah MY 09300
30253556683025355668Molnlycke Health Care SDN BHD1N2026-01-01Lot 12A, Jalan Hi-Tech 7 Industrial Zone Phase 2, Kulim Hi-Tech Park Kulim Kedah MY 09090

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
07333350377205Mepore® - Mepore Roll 4cmx5m+46737733775pedro.lopes@molnlycke.com
07333350625993Mepore® - Mepore Roll 7cmx5m+46737733775pedro.lopes@molnlycke.com
07333350862176Mepore® Pro - Mepore Pro 9x10 cm+46737733775pedro.lopes@molnlycke.com
07333350872489Mepore® - Mepore 10x11 cm+46737733775pedro.lopes@molnlycke.com
07333350904104Mestopore® - Mestopore+46737733775pedro.lopes@molnlycke.com
07333350917159Mepore® Pro - Mepore Pro 9x15cm+46737733775pedro.lopes@molnlycke.com
07333350976712Tubigrip® - Tubigrip B Natural x 10m+46737733775pedro.lopes@molnlycke.com
07333350996147Mepore® - Mepore 9x10cm, ph+46737733775pedro.lopes@molnlycke.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
880671627439027K984368NORMLGEL 0.9% ISOTONIC SALINE GELMGQ1999-02-22
768871565531151K971514REGENT BIOGEL DIAGNOSTIC PROCEDURE GLOVELYY1997-10-29
880671565531151K971514REGENT BIOGEL DIAGNOSTIC PROCEDURE GLOVELYY1997-10-29
1832571565531151K971514REGENT BIOGEL DIAGNOSTIC PROCEDURE GLOVELYY1997-10-29
880671237707897K935189E-Z DERM BIOSYNTHETIC WOUND DRESSINGKGN1994-07-11
880671857828765K934194BARRIER LASER PLUS FACE MASKFXX1994-03-28
880672005612916K920108BARRIER EXTRA PROTECTION PLUS FACE MASKFXX1994-02-10
880671614064232K910557BARRIER* EXTRA PROTECTION PLUS FACE MASKFXX1991-04-29
880671935289946K875107HEALTH CARE EYE PROTECTIONHOY1988-03-21
880671415285602K203369Avance Solo Negative Pressure Wound Therapy (NPWT) SystemOMP2021-07-01
1832571079323936K190077Biogel® PI UltraTouch S Surgical Glove, Biogel® Pl Ultra Touch S Indicator UndergloveKGO2019-05-24
3119751079323936K190077Biogel® PI UltraTouch S Surgical Glove, Biogel® Pl Ultra Touch S Indicator UndergloveKGO2019-05-24
880671079323936K190077Biogel® PI UltraTouch S Surgical Glove, Biogel® Pl Ultra Touch S Indicator UndergloveKGO2019-05-24
768871079323936K190077Biogel® PI UltraTouch S Surgical Glove, Biogel® Pl Ultra Touch S Indicator UndergloveKGO2019-05-24
107131079323936K190077Biogel® PI UltraTouch S Surgical Glove, Biogel® Pl Ultra Touch S Indicator UndergloveKGO2019-05-24
880671982599597K161935Avance Foam Dressing Kit - XLOMP2016-11-04
880671130028110K161797Avance Tubing, Avance Y-Connector, Avance ViewPadOMP2016-10-19
880671792540874K160379Exufiber Ag+FRO2016-08-25
996901792540874K160379Exufiber Ag+FRO2016-08-25
880671663454634K152741Mepiseal Soft Silicone SealantOMP2016-01-22
768871615503784K150146Biogel PI Micro Indicator UndergloveKGO2015-08-31
1832571615503784K150146Biogel PI Micro Indicator UndergloveKGO2015-08-31
880671615503784K150146Biogel PI Micro Indicator UndergloveKGO2015-08-31
1832571276934488K141719BIOGEL PL MICRO SURGICAL GLOVEKGO2014-09-04
880671276934488K141719BIOGEL PL MICRO SURGICAL GLOVEKGO2014-09-04
768871276934488K141719BIOGEL PL MICRO SURGICAL GLOVEKGO2014-09-04
880672037595761K130040MEPITEL AGFRO2014-02-12
880671539790341K123892MEPILEX TRANSFER AGFRO2013-04-05
880671314064668K122132AVANCE FOAM DRESSING KIT INCL. TRANSPARENT FILM, TRANSFER PAD (SMALL, MEDIUM, LARGE) AVANCE TRANSPARENT FILM AVANCE FOAMOMP2013-01-17
1832571666589220K112257BIOGEL PI ORTHOPRO BROWN SURGICAL GLOVEKGO2011-09-20
880671666589220K112257BIOGEL PI ORTHOPRO BROWN SURGICAL GLOVEKGO2011-09-20
3119751666589220K112257BIOGEL PI ORTHOPRO BROWN SURGICAL GLOVEKGO2011-09-20
768871666589220K112257BIOGEL PI ORTHOPRO BROWN SURGICAL GLOVEKGO2011-09-20
880671772791308K102923BARRIER N95 PARTICULATE RESPIRATORMSH2010-11-19
880671802085847K100029MEPILEX BORDER AG DRESSINGFRO2010-09-15
880671084260065K081180SKINSENSE POLYISOPRENE UNDERGLOVEKGO2008-08-26
3119751084260065K081180SKINSENSE POLYISOPRENE UNDERGLOVEKGO2008-08-26
1832571084260065K081180SKINSENSE POLYISOPRENE UNDERGLOVEKGO2008-08-26
768871084260065K081180SKINSENSE POLYISOPRENE UNDERGLOVEKGO2008-08-26
3119751909315816K071700BIOGEL SENSOR SURGEON'S GLOVE WITH NON-PYROGENIC STATEMENTKGO2007-09-11
768871909315816K071700BIOGEL SENSOR SURGEON'S GLOVE WITH NON-PYROGENIC STATEMENTKGO2007-09-11
880671909315816K071700BIOGEL SENSOR SURGEON'S GLOVE WITH NON-PYROGENIC STATEMENTKGO2007-09-11
1832571909315816K071700BIOGEL SENSOR SURGEON'S GLOVE WITH NON-PYROGENIC STATEMENTKGO2007-09-11
3119751976534468K071565BIOGEL INDICATOR UNDERGLOVE WITH NON-PYROGENIC STATEMENTKGO2007-09-10
1832571976534468K071565BIOGEL INDICATOR UNDERGLOVE WITH NON-PYROGENIC STATEMENTKGO2007-09-10
768871976534468K071565BIOGEL INDICATOR UNDERGLOVE WITH NON-PYROGENIC STATEMENTKGO2007-09-10
880671976534468K071565BIOGEL INDICATOR UNDERGLOVE WITH NON-PYROGENIC STATEMENTKGO2007-09-10
1832571020620132K071465BIOGEL ORTHOPAEDIC SURGICAL GLOVE WITH NON-PRYOGENIC STATEMENTKGO2007-09-11
880671020620132K071465BIOGEL ORTHOPAEDIC SURGICAL GLOVE WITH NON-PRYOGENIC STATEMENTKGO2007-09-11
768871020620132K071465BIOGEL ORTHOPAEDIC SURGICAL GLOVE WITH NON-PRYOGENIC STATEMENTKGO2007-09-11
3119751020620132K071465BIOGEL ORTHOPAEDIC SURGICAL GLOVE WITH NON-PRYOGENIC STATEMENTKGO2007-09-11
1832571004033008K071414BIOGEL ECLIPSE, LATEX, POWDER FREE, INDICATOR UNDERGLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)KGO2007-09-10
3119751004033008K071414BIOGEL ECLIPSE, LATEX, POWDER FREE, INDICATOR UNDERGLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)KGO2007-09-10
768871004033008K071414BIOGEL ECLIPSE, LATEX, POWDER FREE, INDICATOR UNDERGLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)KGO2007-09-10
880671004033008K071414BIOGEL ECLIPSE, LATEX, POWDER FREE, INDICATOR UNDERGLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)KGO2007-09-10
880671832933619K071354MEPILEX AG DRESSINGFRO2007-07-13
880671583280660K053443BIOGEL ECLIPSE NON-PYROGENIC LATEX POWDER-FREE STERILE SURGEON'S GLOVEKGO2006-02-01
3119751583280660K053443BIOGEL ECLIPSE NON-PYROGENIC LATEX POWDER-FREE STERILE SURGEON'S GLOVEKGO2006-02-01
1832571583280660K053443BIOGEL ECLIPSE NON-PYROGENIC LATEX POWDER-FREE STERILE SURGEON'S GLOVEKGO2006-02-01
768871583280660K053443BIOGEL ECLIPSE NON-PYROGENIC LATEX POWDER-FREE STERILE SURGEON'S GLOVEKGO2006-02-01
880671499195386K053442BIOGEL SKINSENSE POLY-ISOPRENE POWDER-FREE NON-LATEX GLOVEKGO2006-03-07
768871499195386K053442BIOGEL SKINSENSE POLY-ISOPRENE POWDER-FREE NON-LATEX GLOVEKGO2006-03-07
3119751499195386K053442BIOGEL SKINSENSE POLY-ISOPRENE POWDER-FREE NON-LATEX GLOVEKGO2006-03-07
1832571499195386K053442BIOGEL SKINSENSE POLY-ISOPRENE POWDER-FREE NON-LATEX GLOVEKGO2006-03-07
1832571443707334K053441BIOGEL LATEX POWDER FREE STERILE SURGEON'S GLOVEKGO2006-04-10
768871443707334K053441BIOGEL LATEX POWDER FREE STERILE SURGEON'S GLOVEKGO2006-04-10
880671443707334K053441BIOGEL LATEX POWDER FREE STERILE SURGEON'S GLOVEKGO2006-04-10
1832571920169413K053102BIOGEL SKINSENSE POWDER-FREE NON-LATEX SURGEON'S GLOVEKGO2006-03-10
3119751920169413K053102BIOGEL SKINSENSE POWDER-FREE NON-LATEX SURGEON'S GLOVEKGO2006-03-10
768871920169413K053102BIOGEL SKINSENSE POWDER-FREE NON-LATEX SURGEON'S GLOVEKGO2006-03-10
880671920169413K053102BIOGEL SKINSENSE POWDER-FREE NON-LATEX SURGEON'S GLOVEKGO2006-03-10
1832571634098606K050899BIOGEL LATEX STERILE POWDER-FREE GLOVEKGO2005-08-12
768871634098606K050899BIOGEL LATEX STERILE POWDER-FREE GLOVEKGO2005-08-12
880671634098606K050899BIOGEL LATEX STERILE POWDER-FREE GLOVEKGO2005-08-12
768871206232251K050184BIOGEL SKINSENSE POLY-ISOPRENE POWDER-FREE NON-LATEX GLOVEKGO2005-03-16
3119751206232251K050184BIOGEL SKINSENSE POLY-ISOPRENE POWDER-FREE NON-LATEX GLOVEKGO2005-03-16
1832571206232251K050184BIOGEL SKINSENSE POLY-ISOPRENE POWDER-FREE NON-LATEX GLOVEKGO2005-03-16
880671206232251K050184BIOGEL SKINSENSE POLY-ISOPRENE POWDER-FREE NON-LATEX GLOVEKGO2005-03-16
3119751597951491K000421BIOGEL NEOTECH II POWDER-FREE NEOPRENE SURGEON'S GLOVEKGO2000-08-14
768871597951491K000421BIOGEL NEOTECH II POWDER-FREE NEOPRENE SURGEON'S GLOVEKGO2000-08-14
880671597951491K000421BIOGEL NEOTECH II POWDER-FREE NEOPRENE SURGEON'S GLOVEKGO2000-08-14
1832571597951491K000421BIOGEL NEOTECH II POWDER-FREE NEOPRENE SURGEON'S GLOVEKGO2000-08-14
880671039931295
880671244736648
880671247173425
880671341643336
996901341643336
880671400400945
880671428658944
880671572719055
880671693225722
996901693225722
880671725403762
880671774912780
880671799287143
880671940375439
880672043828272

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
KGO612019-05-24
FRO62016-08-25
OMP52021-07-01
LYY31997-10-29
FXX31994-03-28
MSH12010-11-19
MGQ11999-02-22
KGN11994-07-11
HOY11988-03-21

NDC#

Hibiclens

Molnlycke Health Care

Chlorhexidine Gluconate

Hibiclens

Molnlycke Health Care

Chlorhexidine Gluconate

Hibiclens

Molnlycke Health Care

Chlorhexidine Gluconate

PMN#

MEPILEX

1998-10-28

MOLNLYCKE HEALTH CARE, INC.

GUDID#

80 records. Showing 1-40. Next