Singderm
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Basic Information
- Primary DI
- 06936020106337
- Basic UDI-DI Code
- B-06936020106337
- Reference
- DF-SD-24-1.0
- Device Types
-
Single use Sterile
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 3
- Status
- On The Market
- Manufacturer
- Hangzhou Singclean Medical Products Co., Ltd.
Additional Description
Singderm is a sterile, biodegradable, nonpyrogenic, viscoelastic, clear, colorless, homogenized gel implant. It consists of modifiedl hyaluronic acid (HA) produced by bacteria, formulated to a concentration of 24 mg/ml and 0.3% lidocaine in a physiologic buffer.Singderm is presented in a graduated, pre-filled, disposable syringe. Each box contains one syringe, an instruction leaflet and a set ofl labels in order to ensure traceability. The contents of the Singderm syringe are sterilized by moist heat. If presense, the needles are sterilized by radiation or ethylene oxide.
CND Nomenclature Codes
| Code | Description |
|---|---|
| P900402 | RESORBABLE FILLING AND RECONSTRUCTION DEVICES |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II (excluding section 4) | Ξ.2020.106.13965 | UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ε. | |
| MDD Annex II Section 4 | Ξ.2020.106.13965-1 | UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ε. |
Available In Countries
Similar Devices
Other on-the-market devices with the same classification (Eu Md Class 3) and regulation (EU MDD).