HIALUROM
Basic Information
- Primary DI
- 05944728007239
- Basic UDI-DI Code
- B-05944728007239
- Reference
- HIALUROM
- Device Types
-
Single use Sterile
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 3
- Status
- On The Market
- Manufacturer
- Rompharm Company SRL
Additional Description
HIALUROM is a sterile, viscoelastic solution of sodium hyaluronate. HIALUROM 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 HIALUROM contains 15 mg of sodium hyaluronate, sodium chloride and water for injections. Sterile by moist heat. is a sterile, viscoelastic solution of sodium hyaluronate. HIALUROM 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 HIALUROM 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 | Notified Body | Status |
|---|---|---|---|
| MDD Annex II Section 4 | 252.973 | National Standards Authority of Ireland (NSAI) | Expired |
Available In Countries
Similar Devices
Other on-the-market devices with the same classification (Eu Md Class 3) and regulation (EU MDD).