Eu Mdd
Eu Md Class 3
On The Market
๐ท๐ด Romania
JOINTEC
Devices (same UDI-DI)
1
Certificates
1
Countries
1
Notified Bodies
1
Basic Information
- Primary DI
- 05944728007185
- Basic UDI-DI Code
- B-05944728007185
- Reference
- JOINTEC
- Device Types
-
Single use Sterile
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 3
- Status
- On The Market
- Manufacturer
- Rompharm Company SRL
Additional Description
JOINTEC is a sterile, viscoelastic solution of sodium hyaluronate. JOINTEC 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 JOINTEC 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
๐ฌ๐ท Greece
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