Effectum Medical AG
CH-MF-000012474 · Switzerland · Olten
Effectum Medical AG is registered in the European database on medical devices as a manufacturer, with 21 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 17 |
|---|
Among these devices, 9 are declared sterile, 7 active, 4 with a measuring function.
Authorised representative in the Union: Emergo Europe B.V..
Devices declared under this manufacturer
- ActivCellpen
- DBI-BreathCollector SESI-Adapter
- DBI-BreathCollector Starter Kit-10
- Hall-U-Sana
- Magnes Nushu
- Pantaject® 0.5/1mL
- Pantaject® 3mL
- Picleo Paediatric Dosing Device (de-fr-it)
- Picleo Paediatric Dosing Device (en)
- Picleo Peadiatric Dosing Device (gr-cz-sk)
- Picleo Peadiatric Dosing Device (no-se-dk)
- ReLink Care
Showing 12 of 21 declared devices.
Catalogue references include 008.001.002, 008.001.004, 016.001.001, 016.001.002, 019.001.001-1, 5000584, DBI-C-1001-02.
European nomenclature codes declared: A99, W05019099, Z120603, A0704, Z12030292, Z1212012092.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 21 |
| Country of registration | Switzerland |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 21 |
|---|---|
| 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. Effectum Medical AG was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
1000318721 | supplemented | 2028-01-10 |