It has been approved as a medical device class III under rule 13 in april this year!
"Woulgan® Biogel combines hydrogel components with the company’s proprietary beta-glucan SBG, and has been CE-marked as a medical device Class III, Rule 13 under the EU Directive for Medical Devices. This is an advanced classification. DNV Nemko Presafe has acted as Notified Body responsible for the CE-marking, with the Medicines and Healthcare products Regulatory Authority (MHRA) in the UK acting as the Competent Medical Authority."