Eu Mdd Eu Md Class 3 On The Market ๐Ÿ‡ท๐Ÿ‡ด Romania

CARTInorm XL TRIO

Rompharm Company SRL ยท ๐Ÿ‡ท๐Ÿ‡ด Romania
Devices (same UDI-DI)
1
Certificates
1
Countries
2
Notified Bodies
1

Basic Information

Primary DI
05944728007079
Basic UDI-DI Code
B-05944728007079
Reference
CARTInorm XL TRIO
Device Types
Single use Sterile
Regulation
Eu Mdd
Classification
Eu Md Class 3
Status
On The Market
Manufacturer
Rompharm Company SRL

Additional Description

CARTInorm XL TRIO is a bio-matrix in the form of a sterile, viscoelastic solution consisting of two highly purified cross-linked biopolymers, sodium hyaluronate and chondroitin sodium sulfate, and N-acetylglucosamine (NAG), a naturally amino sugar. CARTInorm XL TRIO contains sodium hyaluronate derived from bacterial fermentation of a Streptococcus strain, chondroitin sodium sulfate sourced from bovine cartilage, and NAG sourced from chitin, a naturally long-chain polymer of N-acetylglucosamine. CARTInorm XL TRIO is a sterile viscoelastic solution processed by aseptic technique and supplied in a disposable glass syringe delivering 2.25 mL of solution.

CND Nomenclature Codes

Code Description
P900402 RESORBABLE FILLING AND RECONSTRUCTION DEVICES

Certificates

Type Number
MDD Annex II Section 4 252.1173

Available In Countries

๐Ÿ‡ญ๐Ÿ‡บ Hungary ๐Ÿ‡ต๐Ÿ‡ฑ Poland

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