BEUDAMED
    16 results · 50ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    EPIEN Medical, Inc

    Manufacturer
    🇺🇸 United States·3 Basic UDI-DIs·3 Devices·2 Importers

    EPIEN MEDICAL, INC.

    FDA registration
    EPIEN MEDICAL, INC.·2 products·🇺🇸 United States

    BUCCAL TOPICAL TREATMENT PREPARATIONS NOT INCLUDED IN OTHER CLASSES

    Device
    EU MDR · Eu Md Class 1 ·EPIEN Medical, Inc·On the market

    HybenX® OTD

    Device
    EU MDR · Eu Md Class 1 ·EPIEN Medical, Inc·On the market

    HybenX® OTD Gel

    Device
    EU MDR · Eu Md Class 1 ·EPIEN Medical, Inc·On the market

    HYBENX Advanced Dental Debridement

    FDA UDI
    Epien Medical, Inc.·00860004740315·HYBENX Advanced Dental Debridement is topical l...

    HYBENX Root Canal Cleanser

    FDA UDI
    Epien Medical, Inc.·00860004740308·EPIEN Root Canal Cleanser is indicated for use ...

    HYBENX Advanced Dental Debridement Gel

    FDA UDI
    Epien Medical, Inc.·00860004740322·HYBENX Advanced Dental Debridement is a topical...

    ORALMEDIC

    FDA Adverse Event
    Injury ·EPIEN MEDICAL, INC.·Product code NEC·May 22, 2025

    HYBENX GEL

    FDA Adverse Event
    Injury ·EPIEN MEDICAL, INC.·Product code KJJ·November 22, 2023

    Oralmedic

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·EPIEN Medical, Inc·1 device

    HybenX® OTD

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·EPIEN Medical, Inc·1 device

    HYBENX OTD Gel

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·EPIEN Medical, Inc·1 device

    ALL-in-1

    Importer
    🇧🇪 Belgium·1 Manufacturer

    QNET B.V.

    Authorized representative
    🇳🇱 Netherlands·33 Manufacturers·364 Devices

    Kalms Consulting GmbH

    Importer
    🇩🇪 Germany·8 Manufacturers