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Mondomed NV

Belgium Last updated 21 Oct 2026

Devices
326
Registries
EUDAMED
FDA recalls
0

Catalogue326

Page 2 of 7

Showing 51-100 of 326

EUDAMED certificates1

EUDAMED certificates (1)

Notified body 1639 1 certificate

  • BE24/00000069 Supplemented

    Quality management system EU MDR

    Issued
    18 Aug 2026
    Expires
    8 Mar 2029
    Reason
    Add device or group

Notified bodies

  • Notified body 1639

About

Ever since 1983, MONDOMED® has been specialising in the production of high-tech PVA (polyvinyl alcohol) foam medical devices.

From the manufacturer's own website. Source

What Mondomed NV makes

Mondomed NV manufactures medical devices primarily consisting of polyvinyl alcohol (PVA) foam products, including nasal tampons and fracture dressings designed for wound care and hemostasis. The portfolio includes items like the Mondocel Nasal tampon for nasal bleeding control and various KREWI-fract foam dressings for managing traumatic fractures and wounds.

These devices are classified under EU Medical Device Regulation as Class I, ensuring compliance with basic safety and performance requirements. They are registered in the EU’s eudamed database, and the company is based in Belgium.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Address
20, Middenweg, Hamont, Belgium
Phone
003211440990(from company website)
PRRC contact
Pasquale Cimmino
EUDAMED SRN
BE-MF-000001283