Minze NV
BE-MF-000022123 · Belgium · Antwerp
Minze NV is registered in the European database on medical devices as a manufacturer, with 10 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 10 |
|---|
Among these devices, 3 are declared active, 1 with a measuring function.
Devices declared under this manufacturer
- Lutastic+
- Minze Diary
- Minze Homecup
- Minze Hospicup
- Minze Peehat
- Minze Platform
- Minze Potty
- Minze Shield
- Minze Standing Man Cup
- Minze Uroflow
Catalogue references include Minze Homecup, Minze Peehat, Minze Shield, Minze Standing Man Cup, Minze1, Minze2.
European nomenclature codes declared: Z12169080, Z12169092, Z121605.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | MINZE NV (BE) · FDA 3016248661 |
| Devices in EUDAMED | 10 |
| Country of registration | Belgium |
Device-level evidence
| Devices with a numeric GTIN | 10 |
|---|---|
| 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: United States only. Minze NV is registered in the United States but was not found in the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
BE23/00000279 | amended | 2028-09-27 |