MaioRegen Prime

Organization name

Fin-ceramica faenza spa

SRN

IT-MF-000023496

Manufacturer status

Active

Certificate health across this manufacturer's portfolio.

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

• CW009

  EUDAMED did not publish a description for this code.
• CW267

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

  EUDAMED did not publish a description for this code.
• CW001

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

  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 18 countries total.

Trade name

MaioRegen Prime

UDI-DI code

18054188161007

Basic UDI-DI

B-18054188161007

Reference / catalog number

01600288

Issuing entity

GS1

Risk category

Class III

Applicable legislation

MDD [Directive 93/42/EEC on medical devices]

Status

On the market

Quantity

1

Additional product description

MaioRegen is a line of reabsorbable implantable medical devices, intended for treating lesions of the cartilage which may affect the subchondral bone structure. MaioRegen Prime is indicated for the treatment of single or multiple grade IV (Outerbridge classification) osteochondral defects with severely compromised bone. Such lesions may be traumatic, post-traumatic, degenerative or due to osteochondritis dissecans (OCD).

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• dimension 1 — 2 MU10
• dimension 2 — 3 MU10
• dimension 3 — 0.6 MU10

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

• P900402RESORBABLE FILLING AND RECONSTRUCTION DEVICES