MaioRegen Slim Oval

Primary DI

18054188161519

Basic UDI-DI Code

805418816MaioRegenCF

Reference

01600305

Device Types

Single use Sterile

Regulation

Eu Mdr

Classification

Eu Md Class 3

Status

On The Market

Manufacturer

Fin-ceramica faenza spa

MaioRegen line of resorbable and implantable medical devices is indicated for the treatment of chondral and osteochondral joint lesions. The devices are provided as a three-dimensional porous and multilayered matrix, consisting of: - a layer of type I collagen fibres (equine origin); - one or two composite layers consisting of type I collagen fibres (equine origin) and magnesium-enriched hydroxyapatite crystals. MaioRegen Slim is indicated for the treatment of osteochondral lesions with moderate subchondral tissue impairment, such as: - traumatic, post-traumatic, degenerative lesions of grade IVa according to the ICRS classification; - grade IV lesions according to the Outerbridge classification; - early osteoarthrosis stage lesions (early OA as defined by Luyten, Knee Surg Sports Traumatol Arthrosc., 2012) and grade I and II lesions according to the Kellgren and Lawrence classification, in the absence of osteophytes.

The Basic UDI-DI associated with this device has 34 devices in total. Below are some other devices sharing the same Basic UDI-DI.

Other on-the-market devices with the same classification (Eu Md Class 3) and regulation (EU MDR).