Molnlycke Manufacturing US, LLC

FDA Device Registration & Listing · Wiscasset, ME, US · Registration 1225263

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
1225263
FEI Number
3000719717
Entity Name
Molnlycke Manufacturing US, LLC
City/State/Country
Wiscasset, ME, US
Establishment Address
11 Twin Rivers Drive, Wiscasset, ME 04578, US
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
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Dermafit Tubipad Tubigrip Setopress Tubifast Elset Static Air Heel Protector Z-Flex Heel Boot Z-Flo Fluidized Positioner

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FQM Bandage, Elastic General Hospital Class 1 880.5075 2009-02-06
FSA Lift, Patient, Non-Ac-Powered General Hospital Class 1 880.5510 2021-08-30
FMP Protector, Skin Pressure General Hospital Class 1 880.6450 2016-12-20
FNG Lift, Patient, Ac-Powered General Hospital Class 2 880.5500 2021-08-30

Official Correspondent

Yannick Spenninck

US Agent Details

No US Agent registered (Local establishment).

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
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
8020673 MOLNLYCKE HEALTH CARE OLDHAM, GB

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K912769 Century Manufacturing Co. PATIENT LIFT AND TRANSPORT 1991-10-02

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0013-2018 Handicare Usa Inc 1
PRISM MEDICAL A-625, MAX. LOAD 625 lbs. 283 Kgs., Patient lift, non-A/C powered
Z-0014-2018 Handicare AB Maskinvagen 1
Carina Mobile Lifts, Models: a) Carina350EM, REF 6060011 b) Carina350EML, REF 60600012 c) Carina350EE, REF 60600009

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1225263. Last updated year: 2026. Please use registration number 1225263 when referencing this establishment in official correspondence.
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