Devices (same UDI-DI)
1
Certificates
2
Countries
1
Notified Bodies
2
Basic Information
- Primary DI
- D-8053303261441DDM42EB
- Basic UDI-DI Code
- B-8053303261441DDM42EB
- Reference
- DDM42BL20XS
- Device Types
-
Single use Sterile
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 3
- Status
- On The Market
- Manufacturer
- Mastelli S.r.l.
Additional Description
Newgyn is a viscoelastic, apyrogenic, sterile gel for single use for intradermal and/or intramucosal infiltrations containing polynucleotides (10 mg/ml) and hyaluronic acid (10 mg/ml)
CND Nomenclature Codes
| Code | Description |
|---|---|
| P900402 | RESORBABLE FILLING AND RECONSTRUCTION DEVICES |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II (excluding section 4) | QCT-0082-18 | ISTITUTO SUPERIORE DI SANITA' | Expired |
| MDD Annex II Section 4 | EPG-0321-21 | ISTITUTO SUPERIORE DI SANITA' | Expired |
Available In Countries
๐ฎ๐น Italy
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