Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8020673

FEI Number

2819

Entity Name

MOLNLYCKE HEALTH CARE

City/State/Country

OLDHAM, GB

Establishment Address

TUBITON HOUSE, Medlock Street, OLDHAM OL1 3HS, GB

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

N/A

PMA Number

N/A

All Registered Proprietary Names

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 Exufiber Ag+ Dermafit Tubipad Tubigrip Setopress Tubifast Elset

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2005-12-21
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2016-11-09
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2009-02-06

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
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

Similar Registrations

Registration Number	Establishment Name	Location
3027643662	ERIBIOTECH CO.,LTD	Suzhou Jiangsu, CN
3006607005	MOLNLYCKE HEALTH CARE (THAILAND), LTD.	Amphur Muang Chonburi Chon Buri, TH
3015432652	E.L.F. COSMETICS INC	Oakland, CA, US
3043138901	DONGGUAN SAMVO BIOTECHNOLOGY CO., LTD	Dongguan Guangdong, CN
3015215566	THE HAIN CELESTIAL GROUP	Hoboken, NJ, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8020673. Last updated year: 2026. Please use registration number 8020673 when referencing this establishment in official correspondence.