Eu Mdd
Eu Md Class 3
On The Market
🇷🇴 Romania
SERTOBEC Tendon
Devices (same UDI-DI)
1
Certificates
1
Countries
2
Notified Bodies
1
Basic Information
- Primary DI
- 05944728010130
- Basic UDI-DI Code
- B-05944728010130
- Reference
- HIALUROM Tendon
- Device Types
-
Single use Sterile
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 3
- Status
- On The Market
- Manufacturer
- Rompharm Company SRL
Additional Description
HIALUROM Tendon is a viscoelastic, isotonic, 40 mg/2 ml solution of sodium hyaluronate in a buffered physiological solution comprised of sodium phosphate, sodium chloride, and mannitol at a pH of 7 - 8. The sodium hyaluronate is purified from the bacterial fermentation of a Streptococcus strain. 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 | 252.970 | National Standards Authority of Ireland (NSAI) | Expired |
Available In Countries
🇷🇴 Romania
🇹🇷 Türkiye
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