Eu Mdr Eu Md Class 2a On The Market 🇺🇸 United States

exofin Micro CE, 0.5g

Chemence Medical Inc. · 🇺🇸 United States
Devices (same UDI-DI)
10
Certificates
0
Countries
10
Notified Bodies
0

Basic Information

Primary DI
00854137001276
Basic UDI-DI Code
854137001MPNKL
Reference
EX91510
Device Types
Single use Sterile
Regulation
Eu Mdr
Classification
Eu Md Class 2a
Status
On The Market
Manufacturer
Chemence Medical Inc.

Additional Description

exofin® is considered a medical device because its intended purpose is not achieved through chemical action within the body or dependent on being metabolised by the body. exofin® Topical Skin Adhesive is classified according to MDR/EU 2017/745 Annex VIII as a Class IIa device, based on Rule 4; exofin® 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

🇨🇿 Czechia 🇬🇷 Greece 🇪🇸 Spain 🇫🇮 Finland 🇫🇷 France 🇮🇹 Italy 🇱🇹 Lithuania 🇵🇱 Poland 🇸🇪 Sweden 🇹🇷 Türkiye

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The Basic UDI-DI associated with this device has 10 devices in total. Below are some other devices sharing the same Basic UDI-DI.

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