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

BIOPORT PLUS

Rompharm Company SRL ยท ๐Ÿ‡ท๐Ÿ‡ด Romania
Devices (same UDI-DI)
1
Certificates
1
Countries
7
Notified Bodies
1

Basic Information

Primary DI
05944728008243
Basic UDI-DI Code
B-05944728008243
Reference
BIOPORT PLUS
Device Types
Single use Sterile
Regulation
Eu Mdd
Classification
Eu Md Class 3
Status
On The Market
Manufacturer
Rompharm Company SRL

Additional Description

BIOPORT PLUS is a sterile, viscoelastic solution of sodium hyaluronate. BIOPORT PLUS 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 BIOPORT PLUS 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‡ฉ๐Ÿ‡ช Germany ๐Ÿ‡ฌ๐Ÿ‡ท Greece ๐Ÿ‡ช๐Ÿ‡ธ Spain ๐Ÿ‡ซ๐Ÿ‡ท France ๐Ÿ‡ฎ๐Ÿ‡น Italy ๐Ÿ‡ต๐Ÿ‡น Portugal ๐Ÿ‡น๐Ÿ‡ท Tรผrkiye

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