MaioRegen Chondro+ Oval

Organization name

Fin-ceramica faenza spa

SRN

IT-MF-000023496

Manufacturer status

Active

Certificate health across this manufacturer's portfolio.

5 warnings recorded — scroll inside the panel to see all entries.

• CW001

  EUDAMED did not publish a description for this code.
• CW009

  EUDAMED did not publish a description for this code.
• CW007

  EUDAMED did not publish a description for this code.
• CW010

  EUDAMED did not publish a description for this code.
• CW032

  EUDAMED did not publish a description for this code.

Primary placement in Italy; available across 17 countries total.

Trade name

MaioRegen Chondro+ Oval

UDI-DI code

18054188161533

Basic UDI-DI

805418816MaioRegenCF

Reference / catalog number

01600406

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 Chondro+ is indicated for the treatment of cartilage lesions with no or mild alteration of the subchondral tissue, such as: grade III traumatic and post-traumatic lesions according to the ICRS classification and grades III-IV ones according to the Outerbridge classification.

Additional information URL

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

Clinical sizes

• Dimension 1 — 1.8 MU10
• Dimension 2 — 3.6 MU10
• Dimension 3 — 0.2 MU10

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

• P900402RESORBABLE FILLING AND RECONSTRUCTION DEVICES