Eu Mdr Eu Md Class 3 On The Market ๐Ÿ‡ฎ๐Ÿ‡น Italy

MaioRegen Chondro+ Oval

Fin-ceramica faenza spa ยท ๐Ÿ‡ฎ๐Ÿ‡น Italy
Devices (same UDI-DI)
34
Certificates
1
Countries
17
Notified Bodies
1

Basic Information

Primary DI
18054188161540
Basic UDI-DI Code
805418816MaioRegenCF
Reference
01600407
Device Types
Single use Sterile
Regulation
Eu Mdr
Classification
Eu Md Class 3
Status
On The Market

Additional 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.

CND Nomenclature Codes

Code Description
P900402 RESORBABLE FILLING AND RECONSTRUCTION DEVICES

Certificates

Type Number
MDR Technical Documentation CVD 0004-23

Available In Countries

๐Ÿ‡ง๐Ÿ‡ช Belgium ๐Ÿ‡ง๐Ÿ‡ฌ Bulgaria ๐Ÿ‡จ๐Ÿ‡ฟ Czechia ๐Ÿ‡ฉ๐Ÿ‡ช Germany ๐Ÿ‡ฌ๐Ÿ‡ท Greece ๐Ÿ‡ช๐Ÿ‡ธ Spain ๐Ÿ‡ซ๐Ÿ‡ท France ๐Ÿ‡ญ๐Ÿ‡ท Croatia ๐Ÿ‡ญ๐Ÿ‡บ Hungary ๐Ÿ‡ฎ๐Ÿ‡น Italy ๐Ÿ‡ฑ๐Ÿ‡น Lithuania ๐Ÿ‡ณ๐Ÿ‡ฑ Netherlands ๐Ÿ‡ต๐Ÿ‡ฑ Poland ๐Ÿ‡ต๐Ÿ‡น Portugal ๐Ÿ‡ท๐Ÿ‡ด Romania ๐Ÿ‡ธ๐Ÿ‡ฎ Slovenia ๐Ÿ‡ธ๐Ÿ‡ฐ Slovakia

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