Pamel d.o.o.
HR-MF-000028336 · Croatia · Zagreb
Pamel d.o.o. is registered in the European database on medical devices as a manufacturer, with 104 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 104 |
|---|
Most frequent device types declared: AC202515, COMBY EEG CAP, ELECUP120, MEC3s-5257, SEC3237.
Among these devices, 89 are declared with a measuring function.
Devices declared under this manufacturer
- Comby EEG cap with 20 Ag/AgCl electrodes - SIGMA, size 42-47, green
- Comby EEG cap with 20 Ag/AgCl electrodes, size 47-52, yellow
- Comby EEG cap with 20 Ag/AgCl electrodes, size 52-57, red
- Comby EEG cap with 21 Ag/AgCl electrodes - MM, size 37-42
- Comby EEG cap with 21 Ag/AgCl electrodes, size 47-52
- Comby EEG cap with 22 Ag/AgCl electrodes, size 52-57, red
- Comby EEG cap with 22 gold plated electrodes, size 52-57, red
- Comby EEG cap with 23 gold plated electrodes, size 47-52
- Comby EEG cap with 24 gold plated electrodes, size 37-42
- Comby EEG cap with 24 gold plated electrodes, size 47-52
- Mini EEG cap, size 42-47
- Mini EEG cap, size 47-52
Showing 12 of 104 declared devices.
Catalogue references include CEC1214752, CEC1225257, CEC2225257, CEC2234752, CEC2243742, Comby EEG cap with 20 Ag/AgCl electrodes, size 47-52, yellow.
European nomenclature codes declared: N01010203, N01010299, N010299, N010180.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | PAMEL D.O.O. (HR) · FDA 3021192567 |
| Devices in EUDAMED | 104 |
| Country of registration | Croatia |
Device-level evidence
| Devices with a numeric GTIN | 104 |
|---|---|
| Found in the U.S. device database | 5 |
| Share | 4.8 % |
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. Pamel d.o.o. is registered in the United States but was not found in the Canadian register.