MaioRegen Prime

Organization name

Fin-ceramica faenza spa

SRN

IT-MF-000023496

Manufacturer status

Active

Certificate health across this manufacturer's portfolio.

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• CW009

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• CW010

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• CW001

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• CW007

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• CW032

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Primary placement in Italy; available across 17 countries total.

Trade name

MaioRegen Prime

UDI-DI code

18054188160963

Basic UDI-DI

805418816MaioRegenCF

Reference / catalog number

01600285

Issuing entity

GS1

Risk category

Class III

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

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 Prime is indicated for the treatment of osteochondral lesions with severe subchondral tissue impairment, such as: - traumatic, post-traumatic, degenerative lesions of grade IVa and IVb 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; - lesions resulting from osteochondritis dissecans.

Additional information URL

https://www.finceramica.it/ifu/maioregen

Clinical sizes

• Dimension 1 — 0.6 MU10
• 1.2 MU10

European Medical Device Nomenclature — the EU product classification assigned to this device.

• P900402RESORBABLE FILLING AND RECONSTRUCTION DEVICES