Eu Mdr
Eu Md Class 2a
On The Market
🇺🇸 United States
derma+flex Mini, 0.36g
Devices (same UDI-DI)
10
Certificates
0
Countries
2
Notified Bodies
0
Basic Information
- Primary DI
- 00850067626008
- Basic UDI-DI Code
- 854137001MPNKL
- Reference
- DF70310
- Device Types
-
Single use Sterile
- Regulation
- Eu Mdr
- Classification
- Eu Md Class 2a
- Status
- On The Market
- Manufacturer
- Chemence Medical Inc.
Additional Description
derma+flex Mini is considered a medical device because its intended purpose is not achieved through chemical action within the body or dependent on being metabolized by the body. derma+flex Mini is classified according to MDR/EU 2017/745 Annex VIII as a Class IIa device, based on Rule 4; derma+flex Mini is a non-invasive device primarily intended to manage the micro-environment of closed skin wounds.
CND Nomenclature Codes
| Code | Description |
|---|---|
| H900199 | TISSUE ADHESIVES - OTHER |
Available In Countries
🇮🇹 Italy
🇵🇱 Poland
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