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

SYNCARTIL

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

Basic Information

Primary DI
05944728007161
Basic UDI-DI Code
B-05944728007161
Reference
SYNCARTIL
Device Types
Single use Sterile
Regulation
Eu Mdd
Classification
Eu Md Class 3
Status
On The Market
Manufacturer
Rompharm Company SRL

Additional Description

SYNCARTIL is a sterile, viscoelastic solution of sodium hyaluronate. SYNCARTIL contains 30 mg/2 ml of sodium hyaluronate with a molecular weight of 1.5 - 2.4 million daltons dissolved in physiological saline solution with the average osmolality of 335 milliosmoles, in a single-use syringe. The sodium hyaluronate is purified from the bacterial fermentation of a Streptococcus strain. Each milliliter of SYNCARTIL contains 15 mg of sodium hyaluronate, sodium chloride and water for injections. Sterile by moist heat.

CND Nomenclature Codes

Code Description
P900402 RESORBABLE FILLING AND RECONSTRUCTION DEVICES

Certificates

Type Number
MDD Annex II Section 4 252.973

Available In Countries

๐Ÿ‡ญ๐Ÿ‡บ Hungary

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