Mondomed NV
BE-MF-000001283 · Belgium · Hamont
Mondomed NV is registered in the European database on medical devices as a manufacturer, with 409 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 409 |
|---|
Most frequent device types declared: ENT, splinting devices.
Among these devices, 65 are declared sterile.
Devices declared under this manufacturer
- Fractomed
- Fractomed Lite
- KREWI-fract
- KREWI-fract blau
- MExT Noseblot
- Mondocel Ear tampon
- Mondocel Nasal tampon
Showing 12 of 409 declared devices.
Catalogue references include 1044861, 1055700, 1055785, 1155518, 744818, 755863.
European nomenclature codes declared: M030504, Q030299, Q030499.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 409 |
| Country of registration | Belgium |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 409 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Not found in the Canadian register |
|---|
⚠️ Canada lists no Class I devices at all — what that excludes.
North American profile: Neither register. Mondomed NV was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
BE24/00000069 | supplemented | 2029-03-08 |