Eu Mdd
Eu Md Class 3
On The Market
🇨🇦 Canada
Revanesse® Ultra 1.0 mL
Devices (same UDI-DI)
1
Certificates
1
Countries
5
Notified Bodies
1
Basic Information
- Primary DI
- D-PN40004PK
- Basic UDI-DI Code
- B-PN40004PK
- Reference
- PN40004
- Device Types
-
Single use Sterile
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 3
- Status
- On The Market
- Manufacturer
- Prollenium Medical Technologies Inc.
Additional Description
Revanesse® Ultra™is a colorless, odorless, transparent and aqueous gel of synthetic origin. The gel is stored in a pre-filled disposable syringe. Each box contains two 1ml syringes of Revanesse® Ultra™along with two sterilized needles.
CND Nomenclature Codes
| Code | Description |
|---|---|
| P900402 | RESORBABLE FILLING AND RECONSTRUCTION DEVICES |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II (excluding section 4) | 301001848ADDE11 | NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY | Expired |
Available In Countries
🇦🇹 Austria
🇧🇬 Bulgaria
🇷🇴 Romania
🇸🇪 Sweden
🇬🇧 United Kingdom
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