Serres Oy
FI-MF-000004504 · Finland · Kauhajoki as.
Serres Oy is registered in the European database on medical devices as a manufacturer, with 201 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 201 |
|---|
Among these devices, 21 are declared with a measuring function.
Devices declared under this manufacturer
- Control valve Plug
- Low trolley 55 cm
- Measuring cup
- On-off valve
- Pre-gelled bag 3000 ml
- Pre-gelled bag, folded
- Suction bag + Suction tube F/F, CH25, 3 m, SerresTip removable
- Suction bag for Laerdal LSU pump 1000 ml
- Suction bag, backflow valve, single packed
- Suction bag, single packed
- Suction canister blue 2000 ml
- Vacuum source protector
Showing 12 of 201 declared devices.
Catalogue references include 570329, 570820, 570959, 57151, 57157-2, 57167-26308.
European nomenclature codes declared: A060301, A0680, A06030401, A0703, A0799, A070199.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | SERRES OY (FI) · FDA 3010300504 |
| Devices in EUDAMED | 201 |
| Country of registration | Finland |
Device-level evidence
| Devices with a numeric GTIN | 201 |
|---|---|
| Found in the U.S. device database | 22 |
| Share | 10.9 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | SERRES OY |
What it holds in Canada
| Licences on record | 1 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 1 |
| First licensed | 2011-12-08 |
Licence types: System (1).
Licensed under: SERRES SUCTION BAG SYSTEM.
North American profile: Both markets. Serres Oy is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
FI22/00000016 | amended | 2027-11-27 |
FI22/00000016 | reissued | 2030-10-24 |