Devices (same UDI-DI)
1
Certificates
2
Countries
1
Notified Bodies
2
Basic Information
- Primary DI
- D-8053303261434DDM11EN
- Basic UDI-DI Code
- B-8053303261434DDM11EN
- Reference
- DDM11BL20XS
- Device Types
-
Single use Sterile
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 3
- Status
- On The Market
- Manufacturer
- Mastelli S.r.l.
Additional Description
Ialest is a viscoelastic, apyrogenic, sterile gel supplied in a pre-filled syringe for single use for intradermal infiltration. Ialest contains hyaluronic acid produced using biotechnology, and is not animal-based.
CND Nomenclature Codes
| Code | Description |
|---|---|
| P900402 | RESORBABLE FILLING AND RECONSTRUCTION DEVICES |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II Section 4 | EPG-0134-18 | ISTITUTO SUPERIORE DI SANITA' | Expired |
| MDD Annex II (excluding section 4) | QCT-0082-18 | ISTITUTO SUPERIORE DI SANITA' | Expired |
Available In Countries
๐ฎ๐น Italy
Similar Devices
Other on-the-market devices with the same classification (Eu Md Class 3) and regulation (EU MDD).
SafeSept Transseptal Guidewire
Device
EU MDD
·
Eu Md Class 3
·Pressure Products Medical Device Manufacturing LLC.·On the market·32 countries
PTCA BALLOON DILATION CATHETERS
Device
EU MDD
·
Eu Md Class 3
·BrosMed Medical Co., Ltd·On the market·32 countries
PTCA BALLOON DILATION CATHETERS
Device
EU MDD
·
Eu Md Class 3
·BrosMed Medical Co., Ltd·On the market·32 countries
Cutanplast Standard
Device
EU MDD
·
Eu Md Class 3
·Mascia Brunelli S.p.A.·On the market·21 countries
PTCA BALLOON DILATION CATHETERS
Device
EU MDD
·
Eu Md Class 3
·BrosMed Medical Co., Ltd·On the market·32 countries
PTCA BALLOON DILATION CATHETERS
Device
EU MDD
·
Eu Md Class 3
·BrosMed Medical Co., Ltd·On the market·32 countries