Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007048057

FEI Number

3007048057

Entity Name

Molnlycke Health Care AB

City/State/Country

Molndal Vastra Gotaland, SE

Establishment Address

Entreprenorsstraket 21, Molndal Vastra Gotaland SE-431 53, SE

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

MOLNLYCKE HEALTH CARE US LLC (Owner Number: 8030877)

Owner / Operator Contact Address

5445 Triangle Parkway, Suite 400, Peachtree Corners, GA 30092, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K053442

PMA Number

N/A

All Registered Proprietary Names

MEFILM MEPITEL ONE Mepitel Film MEPITEL Mepore Film Mepitel Ag Biogel Skinsense N Biogel NeoDerm Biogel Skinsense Indicator Underglove Biogel PI OrthoPro Biogel PI Indicator Biogel M Exufiber Ag+ Biogel Surgeons Glove Biogel Diagnostic Biogel PI Pro-Fit surgical glove Biogel PI UltraTouch M surgical glove Biogel PI Ultratouch G surgical glove Biogel PI UltraTouch surgical glove Mepilex Border Lite Mepilex Mepilex Border Mextra Superabsorbent Mepilex XT Exufiber Mepilex Border Heel Mepilex Transfer Mepore Pro Mepilex Border Flex Mepilex Heel Melgisorb Plus Mepilex Border Post Op Mestopore Mesorb Mepore Film and Pad Mepilex Border Flex Lite Mepilex Up Mestopore S Mepore Roll Mepilex Border Sacrum MESALT MEPORE ALLDRESS Mepilex Lite Biogel PI Micro Indicator Underglove Mepilex Border Heel Ag Mepilex Border Sacrum Ag Mepilex Border Post Op Ag Mepilex Border Ag Normlgel face Mask Barrier Medical Face Mask Barrier N95 Particulate Respirator Biogel Opti-Fit Ortho surgical gloves Biogel PI Micro surgical glove Dermafit Tubipad Tubigrip Setopress Tubifast Elset Barrier Surgical Cap Barrier Nurse's Cap Barrier Surgical Hood Molnlycke Static Air BIOGEL ECLIPSE, LATEX, POWDER FREE, INDICATOR UNDERGLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) Biogel PI UltraTouch S Indicator Underglove Biogel PI UltraTouch S Surgical Glove Tortoise Turning and Positioning System Mepiform Biogel PI surgical glove

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2005-10-06
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2015-05-14
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2009-02-08
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2008-05-07
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2012-02-06
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2009-01-13
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2008-04-02
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2016-11-09
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2008-05-07
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2008-05-07
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2008-05-07
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2005-12-21
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2015-12-21
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2011-07-18
MGQ	Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic	Unknown	Class U	N/A	2016-11-29
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2009-02-08
MSH	Respirator, Surgical	General, Plastic Surgery	Class 2	878.4040	2016-08-03
OPH	Radiation Attenuating Medical Glove	General Hospital	Class 1	880.6250	2026-02-11
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2026-02-11
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2008-05-07
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2015-05-12
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2009-02-06
FYF	Cap, Surgical	General, Plastic Surgery	Class 1	878.4040	2012-02-06
IKY	Mattress, Flotation Therapy, Non-Powered	General Hospital	Class 1	880.5150	2016-12-20
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2008-05-07
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2019-09-25
FMR	Device, Transfer, Patient, Manual	General Hospital	Class 1	880.6785	2016-12-20
MDA	Elastomer, Silicone, For Scar Management	General, Plastic Surgery	Class 1	878.4025	2003-03-12
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2008-05-07

Official Correspondent

Yannick Spenninck

US Agent Details

Yannick Spenninck Business: Molnlycke Health Care Email: yannick.spenninck@molnlycke.com Phone: (470) 3903565

Related Public Records

Same Entity

MOLNLYCKE HEALTH CARE US LLC

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3006607005	MOLNLYCKE HEALTH CARE (THAILAND), LTD.	Amphur Muang Chonburi Chon Buri, TH
1225263	Molnlycke Manufacturing US, LLC	Wiscasset, ME, US
3010099071	MOLNLYCKE MANUFACTURING US, LLC	Brunswick, ME, US
3010309112	Molnlycke Health Care Sdn. Bhd.	Kuala Ketil Kedah, MY
8020673	MOLNLYCKE HEALTH CARE	OLDHAM, GB

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K881936	Iberhospitex, S.A.	OPER-FILM-ADHESIVE MEMBRANE	1988-08-31
K150256	Argentum Medical	SILVERLON BURN CONTACT DRESSINGS	2015-04-30
K002933	Maxxim Medical	STERILE SENSICARE SYNTHETIC POLYISOPRENE POWDER-FREE SURGICAL GLOVES	2000-10-19
K913402	Smith & Nephew Perry	PERRY(R) DERMAGUARD(R) PLUS GLOVES	1991-10-02
K894452	Kerala Rubber & Reclaims, Ltd.	KRR GLOVE, PATIENT EXAMINATION GLOVES	1989-08-09

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0013-2019	COVIDIEN LLC	1	Kerlix AMD Antimicrobial Bandage Roll, 6 Ply, 4-1/2 x 12.3 (11.4 cm x 3.7m), REF 3332 Product Usage- as both primary and secondary dressing containing PHMB (polyhexamethylene biguanide) to resist bacterial colonization within the dressing and bacterial penetration through the dressing.
Z-0014-2019	COVIDIEN LLC	1	Kerlix Bandage Roll, 100% Cotton, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m), REF 6715 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0015-2019	COVIDIEN LLC	1	Kerlix Gauze Roll, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m) Stretched, REF 7880 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0016-2019	COVIDIEN LLC	1	Kerlix Bandage Roll, 100 Cotton, 8 Ply, Large 4-1/2 x 9.3 (11.4 cm x 2.8 m), REF 6716 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0017-2019	COVIDIEN LLC	1	Dermacea Gauze Fluff Roll, 6 Ply, 4-1/2 x 4-1/8 yd (11.4 cm x 3.7 m), REF 441103 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007048057. Last updated year: 2026. Please use registration number 3007048057 when referencing this establishment in official correspondence.