Mondomed NV

Belgium Last updated 21 Oct 2026

Devices: 326
Registries: EUDAMED
FDA recalls: 0

Catalogue326

Page 7 of 7

Fractomed Lite Ref 1055813LL

Class I EUDAMED Active
Fractomed Lite Ref 1055842LR

Class I EUDAMED Active
Fractomed Lite Ref 1055815L

Class I EUDAMED Active
Fractomed Lite Ref 1055810LR

Class I EUDAMED Active
Fractomed Lite Ref 1055770L

Class I EUDAMED Active
Fractomed Lite Ref 1055794LL

Class I EUDAMED Active
Fractomed Lite Ref 1055816AL

Class I EUDAMED Active
Fractomed Lite Ref 1055793LR

Class I EUDAMED Active
Fractomed Lite Ref 1055778LL

Class I EUDAMED Active
Fractomed Lite Ref 1055772LR

Class I EUDAMED Active
Fractomed Lite Ref 1055797LR

Class I EUDAMED Active
Fractomed Lite Ref 1055698LR

Class I EUDAMED Active
Fractomed Lite Ref 1055840LL

Class I EUDAMED Active
Fractomed Lite Ref 1055808L

Class I EUDAMED Active
Fractomed Lite Ref 1055811LL

Class I EUDAMED Active
Fractomed Lite Ref 1055825L

Class I EUDAMED Active
Fractomed Lite Ref 1055778LR

Class I EUDAMED Active
Fractomed Lite Ref 1055693LL

Class I EUDAMED Active
Fractomed Lite Ref 1055806L

Class I EUDAMED Active
Fractomed Lite Ref 1055798LL

Class I EUDAMED Active
Fractomed Lite Ref 1055800L

Class I EUDAMED Active
Fractomed Lite Ref 1055699LL

Class I EUDAMED Active
Fractomed Lite Ref 1055818L

Class I EUDAMED Active
Fractomed Lite Ref 1055678LL

Class I EUDAMED Active
Fractomed Lite Ref 1055817L

Class I EUDAMED Active
Fractomed Lite Ref 1055818AL

Class I EUDAMED Active

Showing 301-326 of 326

EUDAMED certificates1

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
Website: www.mondomed.be
Email: [email protected]
Phone: 003211440990(from company website)
PRRC contact: Pasquale Cimmino
EUDAMED SRN: BE-MF-000001283

Catalogue326

Fractomed Lite Ref 1055813LL

Fractomed Lite Ref 1055842LR

Fractomed Lite Ref 1055815L

Fractomed Lite Ref 1055810LR

Fractomed Lite Ref 1055770L

Fractomed Lite Ref 1055794LL

Fractomed Lite Ref 1055816AL

Fractomed Lite Ref 1055793LR

Fractomed Lite Ref 1055778LL

Fractomed Lite Ref 1055772LR

Fractomed Lite Ref 1055797LR

Fractomed Lite Ref 1055698LR

Fractomed Lite Ref 1055840LL

Fractomed Lite Ref 1055808L

Fractomed Lite Ref 1055811LL

Fractomed Lite Ref 1055825L

Fractomed Lite Ref 1055778LR

Fractomed Lite Ref 1055693LL

Fractomed Lite Ref 1055806L

Fractomed Lite Ref 1055798LL

Fractomed Lite Ref 1055800L

Fractomed Lite Ref 1055699LL

Fractomed Lite Ref 1055818L

Fractomed Lite Ref 1055678LL

Fractomed Lite Ref 1055817L

Fractomed Lite Ref 1055818AL