Mölnlycke Health Care holds several certificates. The certificates can be requested by sending an email to: info.hq@molnlycke.com
(The certificates are available in English only).
Please state the name of the certificate you would like to have sent to you and also the email address the certificate should be sent to. The certificates available for request can be found in the list below.
Quality and Environmental System certificates
Mölnlycke Health Care has decided to meet ISO 9001 (Quality system in design and production), ISO 14001 (Environmental Management system) and the requirements for medical device manufacturers described in ISO 13485 and holds two Quality System Certificates issued by British Standards Institution (BSI).
FM 39247
This is to certify that Mölnlycke Health Care AB Hold Certificate No FM 39247 and operates a Quality Management System which complies with the requirements of ISO 9001:2000
MD 83345
Demonstrates compliance with ISO 13485:2003 - the specific standard for medical device manufacturers.
FM 75630
This is to certify that Mölnlycke Health Care Hold Certificate No FM 75630 and operates a Quality Management System, which complies with the requirements of ISO 13485:2003 for the following scope: The design, development and manufacture of sterile wound and scar dressings, open wound products, wound management gels, cavity dressings, swabs, sponges, sterile alcohol wipes, skin care products, non sterile textile bandages and supports, sterile wound irrigation solutions, abdominal towels, operation sets, surgical and equipment drapes, procedure packs, surgical gowns and other medical staff clothing for use in the patient environment, sterile and non sterile medical surgical gloves and examination gloves and sterile surgical gloves and examination gloves.
For the Canadian market, a special ISO 13485 certificate is needed.
EMS 62098
Demonstrates compliance with ISO 14001:2004, Environmental Management system
CE certificates
The European legislation requires CE-marking of our Medical Devices, which entails a notified body certification (with the exception of non-sterile Class I products for which self-certification applies).
CE 01965
This certificate covers Class ΙΙ a, Class ΙΙ b and Class III medical devices.
The design and manufacture of sterile open wound products, wound management gels, cavity dressings, wound dressings, surgical swabs, sponges, abdominal towels, porcine based wound dressings, procedure packs, medicated and non-medicated polyurethane foam dressings, hydrogel dressings and saline solutions for topical irrigation.
CE 01966
This certificate covers sterile Class Ι products.
The manufacture of alcohol cleansing wipes for disinfecting Medical Devices. Those aspects of manufacture related to maintaining and securing sterility of wound and scar dressings, swabs, sponges, procedure packs, operation sets, surgical and equipment drapes, gloves, surgical gowns, other sterile clothing, knitted primary dressings and polyurethane tracheostomy dressings. Those aspects of manufacturing relating to obtaining sterility in the assembly of procedure packs defined under brand formulas in accordance with Article 12 in the Medical Devices Directive.
CE 91450
The manufacture of sterile and non sterile medical gloves.
CE 01780
Valid for The Private Label Manufacture of Melgisorb® open wound and cavity dressings.
CE 88503
Xelma 1ml Extracellular matrix Protein
CE 81725
This certificate covers Class III Procedure Pak
Class III Procedure packs incorporating class III sutures, sponges and incise films, surgical patties, surgical strips, premium surgiclips, thoracic catheters, Guide Wires, Auto Suture ENDO CLIP Appliers with Metal Clips and a range of non class III single use drapes, incise films, covers, gowns, dressings, swabs (Class I and Class IIa), towels, bandages, syringes, tubing, catheters, cannulae
CE 514235
Mepilex Ag wound dressing with silver salt