Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007605720

FEI Number

3007605720

Entity Name

Molnlycke Health Care Oy

City/State/Country

Mikkeli Etela-Savo, FI

Establishment Address

Saimaankatu 6 PO Box 76, Mikkeli Etela-Savo FI-50101, FI

Establishment Type(s)

Manufacture Medical Device

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

K123892

PMA Number

N/A

All Registered Proprietary Names

Mepitac Mefix Multiple wound dressings Mepilex Border Heel Ag Mepilex Border Sacrum Ag Mepilex Border Post Op Ag Mepilex Border Ag Avance Solo NPWT System Mepitel Ag Mepilex Ag Exufiber Ag+ MEFILM MEPITEL ONE Mepitel Film MEPITEL Mepore Film Mepilex Transfer Ag

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	1996-07-24
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2011-07-18
OMP	Negative Pressure Wound Therapy Powered Suction Pump	General, Plastic Surgery	Class 2	878.4780	2021-08-24
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2015-05-14
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2009-02-09
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2016-11-09
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2005-10-06
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2013-11-12

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
3007048057	Molnlycke Health Care AB	Molndal Vastra Gotaland, SE

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K843874	Beiersdorf, Inc.	LEUKOPOR SURGICAL TAPE	1985-02-21
K915446	Sun Glitz Corp.	STRETCH WRAP	1992-05-06
K833120	Acme United Corp.	ONE TIME COMPOUND BENZOIN TINCTURE-	1983-12-29
K870091	Avery Intl.	IV SECUREMENT DEVICE USING PCCE THERMO. FILM	1987-02-04
K150256	Argentum Medical	SILVERLON BURN CONTACT DRESSINGS	2015-04-30

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-06	B. Braun Medical, Inc.	U	D-Stat Dry Hemostatic Bandage. The product is an adhesive bandage.
Z-0038-2025	3M Company Health Care Business 3m Center	U	3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R
Z-0009-2013	Accuro Medical Product LLC	2	Wound Pro Apex Negative Pressure Wound Therapy Powered Suction Pump; Accuro Medical Products LLC, 2854 Hitchcock Ave, Downers Grove, IL 60515; part number 84635400182, sold inside the Apex Negative Wound Therapy system, part number 84635400181 Promotes wound healing through drainage and removal of infectious material and other fluids from the wound site using continuous and/or intermittent negative pressure. Types of wounds indicated include diabetic/neuropathic ulcers, pressure ulcers, chronic wounds, acute wounds and dehisced wounds.
Z-0039-2015	Smith & Nephew, Inc.	2	RENASYS EZ/ RENASYS EZ Plus 250 mL canister with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus Canisters are used for the collection of exudate removed from wounds being treated by negative pressure wound therapy (NPWT).
Z-0040-2015	Smith & Nephew, Inc.	2	RENASYS EZ/ RENASYS EZ Plus 800 mL canister with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus Canisters are used for the collection of exudate removed from wounds being treated by negative pressure wound therapy (NPWT).

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007605720. Last updated year: 2026. Please use registration number 3007605720 when referencing this establishment in official correspondence.