Devices (same UDI-DI)
1
Certificates
1
Countries
1
Notified Bodies
1
Basic Information
- Primary DI
- 07350108050067
- Basic UDI-DI Code
- B-07350108050067
- Reference
- 690707
- Device Types
-
Single use Sterile Sterilization
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 2b
- Status
- On The Market
- Manufacturer
- Magle Chemoswed AB
Additional Description
The product under review, SmartGel, represents a water-based, amorphous hydrogel intended as wound dressing for the management of dry to moderately exuding wounds. SmartGel contains biodegradable starch microspheres that expand in aqueous solutions and are degraded by α-amylase in vivo.
CND Nomenclature Codes
| Code | Description |
|---|---|
| M04040501 | HYDROGEL DRESSINGS, NON-COMBINED |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II (excluding section 4) | 145067-21-01-21 | CE Certiso Orvos- és Kórháztechnikai Ellenőrző és Tanúsító Kft. | Expired |
Available In Countries
🇩🇪 Germany
Similar Devices
Other on-the-market devices with the same classification (Eu Md Class 2b) and regulation (EU MDD).
Horizontal Steam Sterilizer
Device
EU MDD
·
Eu Md Class 2b
·PROHS Equipamento Hospitalar e Serviços Associados S.A.·On the market·10 countries
Adacolumn
Device
EU MDD
·
Eu Md Class 2b
·JIMRO Co., Ltd.·On the market·9 countries
Echopulse
Device
EU MDD
·
Eu Md Class 2b
·Theraclion·On the market·8 countries
Echopulse
Device
EU MDD
·
Eu Md Class 2b
·Theraclion·On the market·7 countries
Sonovein
Device
EU MDD
·
Eu Md Class 2b
·Theraclion·On the market·6 countries
Mevion S250i
Device
EU MDD
·
Eu Md Class 2b
·Mevion Medical Systems, Inc.·On the market·1 country